Intraoperative Aromatherapy Versus Placebo for Port-a-Cath Placement Under Monitored Anesthesia Care. A Randomized Controlled Trial
Phase: PHASE2
Conditions: Cancer Pain
Sponsor: M.D. Anderson Cancer Center

Pr ot oc ol 2 0 2 1 -0 9 9 4  
Versi o n Date: 0 2/ 0 6/ 2 0 2 3  
Pa ge 1  of 3 5  
St u d y  Titl e : I nt r a o p e r ati v e a r o m at h e r a p y v e r s u s pl a c e b o 
f o r P o rt -a -C at h  pl a c e m e nt  u n d e r M o nit o r e d A n e st h e si a C a r e . 
A r a n d o mi z e d c o nt r oll e d t ri al  
P ri n ci p al  I n v e sti g at o r  ( PI) : N eil B ail a r d  M D  
C o -I n v e sti g at o r (s )  ( C o -I): J u a n P. C at a  M D  
C oll a b o r at o r (s ):  C a ri n H a g b e r g M D , J eff r e y C e r n y M D, S p e n c e r K e e M D, K at y 
F r e n c h M D , Ali ci a  K o w al s ki M D , Eli z a b et h R e b ell o M D 
St ati sti c ia n : L ei F e n g  
S p o n s o r  N a m e : B E E K L E Y C O R P O R A TI O N  
Pr o pri et ar y of M D A n d er s o n C a n c er C e nt er

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SUMMARY TABLE
Title
Intraoperative aromatherapy versus placebo for Port-
a-Cath placement under Monitored Anesthesia Care
(MAC). A randomized controlled trial.
Study Population Size
(# of patients)
70
Study Design
This is a prospective, controlled, randomized trial.
Primary Objective
To compare the time to readiness for discharge (minutes) from 
Post-Anesthesia Care Unit (PACU) after Port-a-Cath placement 
surgery between patients who are randomized to receive 
intraoperative aromatherapy versus placebo
Secondary Objectives
To evaluate the following secondary outcomes:
1) Anxiety score (HADS) in preoperative holding area
2) Midazolam use intraoperatively (mg)
3) Intraoperative opioid use (morphine equivalents)
4) Intraoperative anti-emetic use
5) Time to first occurrence of postoperative nausea or 
vomiting (PONV) in PACU
6) Rate and intensity of PONV in PACU
7) Antiemetic use in PACU
8) Opioid use in PACU (morphine equivalents)
9) Pain intensity in PACU (0-10 numerical rating scale)
10)Patient satisfaction in PACU
Inclusion Criteria
x
Adult patients (≥18 years old) 
x
Undergoing
Port-a-Cath placement
surgery under 
Monitored Anesthesia Care
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x
Signed Informed Consent form
Exclusion Criteria
x
Patients undergoing other surgical procedures 
during Port-a-Cath placement (including explantation of 
a Port-a-Cath or other previous vascular access device)
x
Patients requiring general anesthesia or those not eligible 
for MAC
x
Patients allergic or sensitive to plants, essential oils, or 
any of the medications used in this study
x
Patients with history of G6PD deficiency
x
Patients with history of atrial fibrillation
x
Patients unable to complete study questionnaires
x
Patients who are completely anosmic or who have history 
of intolerance to aromatherapy.
x
Patients who have been taking any opioid daily for 90 
days or more
x
Patients who have been taking any benzodiazepine daily 
for 30 days or more
Study Procedures
Pretreatment
Evaluation
Eligible subjects will be identified from within the patient 
population of the study site. There will be no advertisements 
for study subjects.
On-Study Visits
All study procedures and data collection will occur on the day 
of surgery.
Follow-up Visits
None
End of Study Visit
None
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Brief Analysis Plan
We will summarize continuous demographics and clinical 
variables using means, standard deviations, medians and 
ranges. Categorical demographic variables and clinical 
variables will be summarized through frequencies and 
percentages. Fisher’s exact test or Chi-square test will be 
used to evaluate the association between two categorical 
variables of interest. Wilcoxon-rank sum test or t-test will be 
used to compare continuous outcomes between treatment 
groups. Linear/logistic regression model may be fitted to 
assess 
the 
effect 
of 
important 
covariates 
on 
the 
primary/secondary endpoints.
1. OBJECTIVES
The primary objective is to compare the time to readiness for discharge from PACU 
(minutes) after Port-a-Cath placement surgery between patients who are randomized to 
receive intraoperative aromatherapy versus placebo
Secondary Objectives are to evaluate the following secondary outcomes: 
1.
Anxiety score (HADS) in preoperative holding area
2. Midazolam use intraoperatively (mg)
3. Intraoperative opioid use (morphine equivalents)
4. Intraoperative anti-emetic use
5. Time to first occurrence of postoperative nausea or vomiting in PACU
6. Rate and intensity of PONV in PACU
7. Antiemetic use in PACU
8. Opioid use in PACU (morphine equivalents)
9. Pain intensity in PACU (0-10 numerical rating scale)
10. Patient satisfaction in PACU
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2. BACKGROUND
2.1. Porta-Catheter placement
A Porta-Catheter (Port-a-Cath) is a vascular access device placed completely under the skin 
on either side of the chest. The device is routinely placed to deliver chemotherapy treatments, 
obtain blood draws or infuse fluids intravenously. Port-a-Cath placement may be performed 
under general anesthesia or sedation (Monitored Anesthesia Care, MAC) depending on patient 
health factors and preference. Intraoperative anxiety is a common problem when MAC instead 
of general anesthesia is used during minor surgical procedures such as Port-a-Cath placement. 
Johansson et al. reported that 60% of the patients felt “unpleasant” during Port-a-Cath 
insertion under local anesthesia. Intraoperative anxiety is associated with a negative influence 
on pain perception, increased use of sedatives like benzodiazepines (i.e., midazolam) and 
opioids, prolonged recovery after surgery and unnecessary postprocedural hospitalization. 
Benzodiazepines such as midazolam produce calming effects via binding to GABAA receptors.
Fatigue, confusion, respiratory depression, and restlessness are undesirable adverse effects of 
midazolam and opioids which limit patients’ ability to actively participate in their intra- and 
postoperative care. Furthermore, Chang et al. found that the use of benzodiazepines does not
improve patient’s satisfaction during Port-a-Cath placement. Non-benzodiazepines drugs such 
as dexmedetomidine can also been used to provide procedural anxiolysis. Intraoperative 
sedation with i.v. dexmedetomidine has demonstrated significant reduction in the 
postoperative opioid consumption and prolongation of postoperative analgesia when general
anesthesia is avoided, as reported by Giordano et al. However, dexmedetomidine can cause 
hypotension and bradycardia and prolonged sedation. As a result of the potential adverse of 
benzodiazepines and dexmedetomidine, and opioids, non-pharmacological therapies have 
been studied to limit their excessive use intraoperatively.
Music, a non-pharmacological intervention, has been studied to reduce anxiety in minor 
surgery. While Schaal et al. indicated that perioperative music did not reduce anxiety or 
cortisol levels during Port-a-Cath placement, McDaniel et al. reported that music via 
headphones (though not via loudspeakers) resulted in significantly lower anxiety after the 
procedure compared to the beginning. However, a major deficiency in McDaniel’s study was 
the lack of randomization to the studied interventions and that musical therapy can interfere 
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with the patients’ ability to follow commands. Therefore, it is important to examine other non-
pharmacological intraoperative interventions which may be able to reduce anxiety and the use 
of excessive doses of midazolam and opioids, as well as improve recovery after Port-a-Cath 
placement.
2.2 Aromatherapy
Essential oils have a long tradition in pharmaceutical sciences as natural products with 
pharmacological applications. Aromatherapy, the therapeutic use of essential oils extracted 
from aromatic plants, may offer a simple, lowǦrisk and costǦeffective method of managing 
intraoperative anxiety. Aromatherapy is fastǦacting, noninvasive, has minimal side effects, and 
can be applied in multiple forms including aromatabs. It has been demonstrated that 
inhalation aromatherapy molecules act on olfactory receptors located in primary olfactory 
neurons. Upon activation of olfactory neurons, an action potential is generated and propagated 
via the olfactory tract which projects from the lateral olfactory stria to the amygdala, a key 
structure of the limbic system involved in behavior and emotions. Lv et al. suggested that anti-
anxiolytic mechanisms included interaction with NMDA or GABAA receptors, voltageǦ
dependent sodium channels, voltageǦdependent calcium channels, and glutamatergic and 
cholinergic neurotransmission.
Various essential oils have been studied to reduce anxiety. Linalyl acetate and linalool are 
molecules found in lavender. The former has narcotic actions while linalool is considered a 
sedative, an NMDA antagonist and an inhibitor of serotoninergic targets. Yuan et al. proposed 
that both molecules also exert anti-inflammatory effects by inhibiting activation of NF-kB and 
the release of pro-inflammatory cytokines (i.e., TNF-a, IL-1B and PGE2). The sedative effects 
of lavender aromatherapy have been studied in multiple clinical studies. A meta-analysis by 
Perry et al. showed a lack of conclusive evidence to indicate aromatherapy for the treatment of 
preoperative anxiety. However, more recent studies have shown promising results. For 
instance, Wotman et al. demonstrated a reduction in preoperative anxiety in ambulatory 
surgery patients treated with aromatherapy undergoing procedures in general otolaryngology. 
A major limitation of the study was the lack of a placebo-controlled arm. Comparable results
were reported by Jaruzel et al. in a pilot observational study in breast cancer patients and by 
Beyliklioğlu et al. in a randomized controlled trial. Kim et al. in a study of acupuncture needle 
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insertion found that subjects who inhaled a lavender oil for 5 minutes demonstrated a decrease 
in anxiety, less needle insertion pain, and Bispectral Index (processed EEG) changes suggestive 
of sedation.
Peppermint oil has long been valued for its antinausea effect. Grigoleit et al. found that 
menthol and menthone, the main constituents of peppermint oil, appear to act as smooth 
muscle relaxants through calcium channel blockade when the oil is orally ingested. As an
inhaled vapor, peppermint oil likely acts through another mechanism, such as by influencing 
neurotransmitter release at the chemoreceptor trigger zone of the medulla. Hines et al., in a 
systematic review, found that aromatherapy appeared to be no better than placebo in 
preventing nausea, although there was some evidence that patients who had received 
aromatherapy required fewer antiemetic medications. Hines et al. rated the quality of the 
included studies as moderate to very low by GRADE (Grading of Recommendations, 
Assessment, Development and Evaluations) criteria, however. More recently, Ahmadi et al.
found peppermint oil aromatherapy to be effective in reducing nausea after abdominal surgery. 
Maghami et al. found that peppermint oil aromatherapy was effective in reducing nausea after 
open-heart surgery, although the peppermint oil was delivered via in-line nebulizer in patients 
who remained intubated, limiting the study’s generalizability. 
Because the existing literature is equivocal for both lavender and peppermint 
aromatherapy, we believe that a well-designed placebo-controlled trial may help to resolve 
some of the uncertainty as to their clinical effectiveness in the ambulatory perioperative 
setting. As well, to our knowledge there have been no studies of aromatherapy conducted on 
subjects undergoing surgery performed under Monitored Anesthesia Care (versus general 
anesthesia).
Our primary hypothesis is that preoperative and intraoperative placement of an active 
lavender-peppermint patch (vs. placebo patch) will result in a shorter time to discharge-
readiness in the post-anesthesia care unit (PACU). Secondary hypotheses are that subjects 
randomized to active aromatherapy patch will have lower midazolam use intraoperatively 
(mg), lower intraoperative opioid use (morphine equivalents), lower supplemental 
intraoperative antiemetic use, longer time to first occurrence of PONV, lower rate and intensity 
of post-operative nausea or vomiting in PACU, lower rate of rescue antiemetic use in PACU, 
lower maximum pain intensity in PACU (0-10 numerical rating scale), and higher patient 
satisfaction in PACU (Likert scale).

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3. Background Device Information
Aromatabs® are inhalational aromatherapy patches intended to self-adhere to a patient’s 
gown or clothing and release pleasant odors over several hours (up to 8 hours, per 
manufacturer). The essential oils themselves do not contact with the patient’s skin, since the 
patch is contained in a plastic envelope, and it is this plastic envelope that is affixed to the 
patient’s gown or clothing. https://beekley.com/product-details/elequil-aromatabs-lavender-
peppermint-373
The Aromatabs® patches will be stored in a secured cabinet in the study team office, 
following storage guidelines from the manufacturer. Each patch will be labeled in accordance
with FDA regulations and institutional policies before use. Detailed records of receipt, use or 
disposition will be maintained by the Principal Investigator in accordance to FDA regulations 
and institutional policies.
This is study is not intended to promote nor market Aromatabs®.
4. Study Design
This is a prospective randomized controlled trial.
5. Discussion of Study Population
5.1 Study Characteristics
Number of Subjects: This study will enroll 70 patients. We anticipate that we will have at 
least 62 eligible and treated patients.
5.2 Inclusion and Exclusion Criteria
a) Inclusion Criteria
Ɣ
Adult patients (≥18 years old) 
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Ɣ
Port-a-Cath placement under Monitored Anesthesia Care
Ɣ
Signed informed consent
b) Exclusion Criteria
x
Patients undergoing other surgical procedures during Port-a-Cath placement
(including explantation of a Port-a-Cath or other previous vascular access device)
x
Patients requiring general anesthesia or those not eligible for MAC
x
Patients allergic or sensitive to plants, essential oils, or any of the medications used in 
this study
x
Patients with history of G6PD deficiency
x
Patients with history of atrial fibrillation 
x
Patients unable to complete study questionnaires
x
Patients who are completely anosmic or who have history of intolerance to 
aromatherapy
x
Patients who have been taking any opioid daily for 90 days or more
x
Patients who have been taking any benzodiazepine daily for 30 days or more
6. Subject Identification, Recruitment and Consent
6.1 Method of Subject Identification and Recruitment
Eligible subjects will be identified from within the patient population of the study site by 
members of the research team. Advertisements for study subjects are not anticipated.
6.2 Consent Process
Subjects deemed eligible to participate in the study will be explained in detail the purpose, 
nature, and procedures of the study, as well as the potential risks, benefits, and alternatives. 
They will be given a consent form to read and if they so choose, to discuss with friends, family, 
and other clinicians. They will be invited to ask questions and, after all questions are answered
to their satisfaction, invited to sign the consent form. The Principal Investigator or another 
member of the research team will participate in the consenting process to ensure the subject
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has full understanding of the procedure and risks. No study-specific procedure will be
performed before the consent form is signed.
A separate consent document for the port-a-cath will be explained by your surgery team.
All consents will be signed electronically within the medical record on a MD Anderson 
Cancer Center password protected computer.
6.3 Costs to the Subject
None
6.4 Payment for Participation
There will be no payments for participation in the study.
6.5 Return of Individual Research Results
Individual research results will not be provided back to the subject.
7. Methods and Study Procedures
7.1 Pretreatment Evaluation
The PI/Co-PI/research coordinator of the study will evaluate the inclusion/exclusion
criteria. Patients will be approached while in the preoperative area to discuss participation in
the study. The PI/Co-PI/research coordinator will ensure that patients are properly informed
about the study. All study related data will only be collected after the PI or Co-PI approves
patient enrollment in the study and the patient has signed the consent.
7.2 Procedure
Prior to surgery, subjects will be randomized to either a lavender/peppermint patch 
(Elequis Aromatabs®, Beekley Corporation (https://beekley.com/aromatherapy/elequil-
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aromatabs-aromatherapy-designed-for-the-clinical-setting) or a matching placebo patch. The 
assigned Aromatab® will be activated in the preoperative holding area by opening the outer 
plastic envelope and then affixed to a folded towel placed aside the subject’s head, contralateral 
to the side of the planned surgery. The towel and Aromatab® will be transferred to the 
operating table with the subject as they arrive in the operative suite and maintained beside the 
subject’s head throughout the surgery.
All subjects will have standard physiologic monitors placed on arrival to the operating room 
as per American Society of Anesthesiologists standards. They will have a nasal oxygen cannula 
or face mask placed to maintain adequate oxygenation. An anesthesia provider (Certified 
Registered Nurse Anesthetist and/or Physician Anesthesiologist) will be present with them 
continuously from the time they leave the preoperative holding area until the time that they 
reach the PACU, and a handoff is given to the receiving PACU nurse. Patients will be eligible to 
receive a maximum dose of 2 mg midazolam i.v. in the preoperative holding area just before 
transporting to the operative suite (standard of care, depending on patient’s age, physiologic 
condition, and preference). The anesthesia provider will administer intraoperative doses of 
midazolam i.v. and opioid i.v. as needed, titrating to the desired level of sedation. The towel 
and Aromatab® will be discarded when the subject leaves the operating room. Prophylactic 
antiemetics will be administered per anesthesiologist clinical judgment, as Port-a-Cath 
placement is not known to carry a high risk of postoperative nausea and vomiting (PONV), and 
general anesthesia is not being administered. Further, midazolam itself is known to have an 
antiemetic effect, as reported by Grant et al. If subjects report experience nausea or vomiting 
during the procedure, rescue emetics will be administered as necessary and per standard of 
care.
Postoperatively, all subjects will be taken to the PACU and cared for by a PACU nurse in 
standard fashion until they are discharged. Under the current standard of care, the surgeon 
injects local anesthetic around the surgical wound, thus very few current outpatient Port-a-
Cath patients require postoperative opioids. If subjects have breakthrough pain, postoperative 
opioids or other analgesics will be administered as necessary and per standard of care. If the 
subjects experience postoperative nausea or vomiting in PACU, rescue emetics will be 
administered as necessary and per standard of care. In the PACU, a research coordinator, 
research fellow, collaborator, or other member of the research team will assess patient’s 
nausea/vomiting, pain intensity and satisfaction.
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7.3 Training of Clinical Site Personnel
The PI will conduct a training session with all anesthesia collaborators. The anesthesia 
collaborators will view a video demonstrating preparation and positioning of the aromatherapy 
patch/placebo patch on a folded towel, and placement of that towel next to the patient’s head.
7.4 Data Collected from EMR
x
Demographics (e.g., BMI, age, gender, and ethnicity)
x
Comorbidities (Charlson score)
x
Dosing and type of preoperative, intraoperative, and postoperative medications
x
Information regarding sedation management intraoperatively
x
Sedation times (sedation start from placement of aromatab or placebo to procedure
end)
x
Procedure times (procedure start to procedure end)
7.5 Additional Data Collected by Research Coordinator
x
Hospital Anxiety and Depression Score (HADS) recorded in preoperative holding 
area after subject has given consent
x
Aldrete Parsap recovery scores, recorded every 15 minutes in PACU from patient 
arrival (Anesthesia End timepoint) until a Parsap score of 18 or higher
x
Time in minutes from Anesthesia End to Aldrete Parsap score of 18 or higher
x
Pain intensity using the Verbal Numeric Rating Scale (0: no pain and 10 worst pain 
ever) every 15 minutes from procedure end until a Parsap score of 18 or more is 
reached
x
Nausea intensity using the Verbal Numeric Rating Scale (0: no nausea and 10 worst
nausea ever) every 15 minutes from procedure end until a Parsap score of 18 or more 
is reached. 
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x
Vomiting: The number of episodes of vomiting will be recorded every 15 minutes 
from procedure end until a Parsap score of 18 or more is reached. 
x
Patient satisfaction (Patient-Reported Outcome, Likert scale), assessed as soon as a 
Parsap score of 18 or more has been reached.
x
Apfel Post-Operative Nausea and Vomiting Risk Score
8. Subject Withdrawals
Subjects may be withdrawn from the study for the following reasons:
1) Subject non-compliance with study procedures
2) Unacceptable adverse events (safety or tolerability)
3) The subject may withdraw from the study at any time and for any reason
4) Clinician decision that it is in the best interest of the subject to withdraw from the
study
9. Safety and Reportable Events
9.1 Adverse Event Definition
An adverse event is any symptom, sign, illness, or experience which develops or worsens 
during the course of the study, whether or not the event is considered related to investigational 
product. This includes a change in a subject's condition or laboratory results, which has or 
could have a deleterious effect on the subject's health or well-being. An Adverse Event that is 
related to the investigational device may be referred to as an Adverse Device Effect (ADE). 
Unanticipated Adverse Device Effect (UADE): Any device related adverse event, the nature 
or severity of which is not consistent with or listed in the applicable product information (e.g., 
instructions for use, subject informed consent document, subject information brochure [if 
applicable], promotional literature) or any other unanticipated serious problem associated 
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with a device that relates to the rights, safety, or welfare of subjects. These are dichotomous 
outcomes.
Expected Adverse Events
The experimental treatment is generally recognized as safe. No adverse events are expected.
9.2 Serious Adverse Event
A serious adverse event is defined as any adverse medical experience that results in any of 
the following outcomes:
x
Death
x
Is life-threatening
x
Requires inpatient hospitalization or prolongation of existing hospitalization
x
Results in persistent or significant disability/incapacity
x
Is a congenital anomaly/birth defect
x
Requires medical or surgical intervention to prevent permanent impairment or damage
9.3 Recording Adverse Events
All adverse events (AE) and serious adverse events (SAE) will be monitored from the 
time of procedure through end of the study. Th PI will immediately conduct an evaluation of 
any unanticipated adverse device effect.
An AE is defined as any undesirable clinical occurrence in a patient whether or not it is 
considered to be device related. In addition, the definition of AE applies to any event with an 
onset post study procedure or to any underlying diseases, present at baseline, that exacerbate 
in severity post study procedure. Therefore, an underlying disease that was present at the time 
of enrollment is not reported as an AE, but any increase in the severity of the underlying 
disease is to be reported as an AE. All reported AEs must be recorded in the database. A 
description of the event, including the start date, resolution date, action taken, and the 
outcome should be provided, along with the Investigator’s assessment of the relationship 
between the AE, the study treatment and the study procedure. This protocol will use common 
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terminology criteria for adverse events (CTCAE) version 4.0. For the AEs not characterized in 
the CTACE, the following definitions for rating severity of AEs will be used:  
Mild:
Awareness of signs or symptoms, but easily tolerated; are of minor 
irritant type; causing no loss of time from normal activities; 
symptoms would not require medication or a medical evaluation; 
signs or symptoms are transient.
Moderate:
Interferes with the patient’s usual activity and/or requires 
symptomatic treatment.
Severe:
Symptom(s) causing severe discomfort and significant impact of 
the patient’s usual activity and requires treatment.
A serious adverse event (SAE) is defined as an event which leads to:  
x
Death due to any cause
x
Life-threatening condition
x
Results in persistent or significant disability/incapacity
x
Requires in-patient hospitalization or prolonged hospitalization
x
Necessitates an intervention to prevent a permanent impairment of a body 
function or permanent damage to a body structure
x
Results in congenital abnormality
All SAE’s will be reported.
For purposes of this study, the following events are not considered adverse events, 
because they are normally expected to occur in conjunction post-surgery, or are associated with 
customary, standard care of patients undergoing these procedures:
x
Early post-operative pain (within 48hours post-index procedure) at the incision site 
and/or related to position on procedure table
x
Post-anesthesia emesis, nausea, or headache (within 24 hours post-index procedure)
x
Chest pain without associated ECG changes 
x
Electrolyte imbalance without clinical sequalea following endoscopic procedure, 
even if requiring correction
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x
Low grade temperature increase (d38.3qC/d101qF) 
x
Any pre-planned surgical procedures
This listing of events is intended to provide guidance to the investigational sites for 
purposes of adverse event reporting.  The Investigator at the investigational site should utilize 
his/her own clinical judgment in evaluating adverse experiences and may decide that the above 
events should be reported as adverse events.  
9.4 Responsibilities for Reporting Serious Adverse Events
The Investigator should record all serious adverse experiences that occur during the study 
period in the appropriate source documents and/or AE log as applicable. The study period 
for reporting serious adverse events (e.g., from the time of signing consent to final study 
visit) should be indicated, who needs to be notified and the time frame for notification. If 
there are any specific reporting forms to be completed, this should be indicated here. The 
Investigator will comply with regulations and institutional review board (IRB) policy 
regarding the reporting of adverse events.
If the PI determines that an unanticipated adverse device effect presents an unreasonable 
risk to subjects, the PI will terminate all investigations or parts of investigations presenting 
that risk as soon as possible. Termination shall occur not later than 5 working days after the 
PI makes this determination and the manufacturer shall be informed of any malfunctions 
or adverse device effects within 15 working days of PI acknowledgement of the event. PI 
may not resume a terminated investigation without IRB and FDA approval.
10. Risk/Benefit Assessment
10.1 Potential Risks
x
Skin or eye irritation from the aromatic oils or other components of the patch
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10.2 Protection Against Risks
x
Appropriate patient selection
x
Continual monitoring of the patient throughout the perioperative period
x
Affixing of the aromatherapy patch to a towel placed next to the patient’s head, rather 
than to the patient’s gown or to their skin
x
No direct contact with the oils themselves (safely contained in the plastic envelope of the 
Aromatab® patch itself)
10.3 Potential Benefits to Subjects
x
Decreased sedation or drowsiness
x
Less post-operative nausea
x
Reduction in time spent in the PACU, more rapid fitness for discharge
10.4 Alternatives to Participation
x
The patient may decline to participate, in which case standard of care Monitored 
Anesthesia Care will be provided
11. Confidentiality of Data and Information Storage
All study participants will be assigned a study number. The PI will maintain the key to the 
study number and medical record number in a password locked MD Anderson computer.
Information about study subjects will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
Patient data will be entered into a password protected electronic spreadsheet and online 
database (i.e., REDCap). Only the investigators, who have been invited to participate in the 
study and who are registered with the IRB, as well as have documented completion of all IRB 
and HIPAA regulations will have access to patient data, but not the medical record key. 
Electronic records will be stored for 5 years after study conclusion on the institution’s 

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password protected computer, after which time they will be deleted. If there is a breach in 
confidentiality or violation of IRB and HIPAA regulations, the IRB will be notified in a timely 
manner (within 7 days) and appropriate actions taken thereafter. All data used in the analysis 
and reporting of this investigation will be de-identified. Any photography shall be done in a 
discrete manner. Should images run the risk of enabling patient identification, identifying 
characteristics will be obscured electronically prior to publication.
In order to ensure compliance with the Health Insurance Portability and Accountability Act 
(HIPAA), all subjects enrolled in the study will be required to provide authorization to disclose 
Protected Health Information (PHI). This authorization will be included in the informed 
consent document as required by the IRB. In all study reports and in any resulting 
publications, subjects will not be referred to by their initials and/or study identification 
number.
12.
Sample Determination and Data Analysis
12.1 Randomization
Once patients meet all inclusion criteria and after consenting, they will be randomized 
to receive either Aromatab® patch or placebo patch with a 1:1 allocation ratio. Concealment 
of treatment will occur until two hours prior to surgery. Patients and O.R. caregivers will 
not be blinded as to their study group (not feasible).
12.2 Sample Size Determination
This is a randomized controlled trial to compare the time to readiness for discharge 
from PACU (minutes) after Port-a-Cath placement surgery between the patients who are 
randomized to receive intraoperative aromatherapy (Aromatab® patch) versus placebo. We 
will enroll 70 patients, and we anticipate that we will have at least 62 eligible and treated 
patients. Patients will be randomized to receive either Aromatab® patch or placebo patch 
with a 1:1 allocation ratio. The primary objective of the study is to determine if patients
randomized to receive Aromatab® patch will have a significantly shorter time to readiness 
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for discharge from PACU (minutes) after surgery when compared to patients who receive a 
placebo patch. The primary endpoint, time to readiness for discharge from PACU after 
surgery, is defined as the time interval in minutes, from the end of surgery to the time when 
a patient is evaluated as ready to be discharged from PACU. We observed from previous 
data on the patients treated with standard of care (same as placebo) that the mean PACU 
duration was 66.5 minutes with a standard deviation of 20.7. The study with 31 patients in 
each treatment arm will have 80% power to detect a difference of 15 minutes in mean time 
to readiness for discharge from PACU after surgery between 66.5 minutes for the placebo 
arm and 51.5 minutes for the aromatherapy arm assuming a common standard deviation of 
20.7 using a two group t-test with a two-sided type I error rate of 0.05 (nQuery+nTerim 
4.0).
12.3 Planned Statistical Analysis
We will summarize continuous demographics and clinical variables, such as age, surgery 
time, anesthesia time, amount of medication, time in PACU, and pain score, using means, 
standard deviations, medians, and ranges. Categorical demographic variables and clinical 
variables, such as gender, incidence, and intensity of PONV, incidence of antiemetic use in 
PACU, will be summarized through frequencies and percentages. Fisher’s exact test or Chi-
square test will be used to evaluate the association between two categorical variables of 
interest. Wilcoxon-rank sum test or t-test will be used to compare continuous outcomes 
such as time to readiness for discharge from PACU (minutes) after surgery between 
treatment groups. Linear/logistic regression model may be fitted to assess the effect of 
important covariates on the primary/secondary endpoints.
12.4 Data Collection and Management
All study data will either be collected on a paper case report form (CRF) (which will be
entered into a computer database) or will be extracted directly from the EMR to the 
REDCap database. Each subject will be assigned a random number code and the key linking
the code and the subject identifier will be stored on an MD Anderson password protected 
computer. All changes to the CRF will follow Good Clinical Practice guidelines. The
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Research Manager is responsible for auditing the consistency of the data transcribed from
the paper CRF to the computer. A protocol violation log will be maintained, and all protocol
violations will be reported to the IRB.
Members of the research team are responsible for transferring the information to the 
appropriate CRFs. The PI is responsible for ensuring the forms are accurately completed at 
the time of, or as soon as possible after, the subject procedure or the availability of test 
results. The PI is required to sign the CRF on the appropriate page(s) to verify that she has 
reviewed the recorded data. Upon PI approval, CRFs will be entered into the password 
protected REDCap database for analysis.
The PI will not share any of the data collected in this study with the Sponsor.
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13. References
1.
Johansson E, Engervall P, Björvell H, Hast R, Björkholm M. Patients' perceptions of 
having a central venous catheter or a totally implantable subcutaneous port system-
results from a randomised study in acute leukaemia. Support Care Cancer. 2009 
Feb;17(2):137-43.
 Giordano C, Pini Prato A, Casciaro R, Simonini A (2018) Dexmedetomidine Infusion 
Perioperative to Control Agitation in Non-intubated Young Patient with Cystic Fibrosis 
Undergoing Upper Arm Ultrasound Guided Totally Implantable Port-A-Cath Placement: 
A Case Report. Analg Resusc: Curr Res 7:1.
3. Chang DH, Hiss S, Herich L, Becker I, Mammadov K, Franke M, Mpotsaris A, Kleinert 
R, Persigehl T, Maintz D, Bangard C. Implantation of venous access devices under local 
anesthesia: patients' satisfaction with oral lorazepam. Patient Prefer Adherence. 2015 
Jul 7;9:943-9.
4. Schaal NK, Brückner J, Wolf OT, Ruckhäberle E, Fehm T, Hepp P. The effects of a music 
intervention during port catheter placement on anxiety and stress. Sci Rep. 2021 Mar 
11;11(1):5807.
5. McDaniel C, Burkett AM, Cormier M, Duvall J, Davis S, Gabriel L et al. PICC, The Music 
and Travel to the Port of Relaxation: The Effects of Music on Perceived Pain and Anxiety 
in Patients Receiving PICCs and Port-A-Caths. J Radiol Nurs, 28(1), 32-34. 
6. Lv XN, Liu ZJ, Zhang HJ, Tzeng CM. Aromatherapy and the central nerve system 
(CNS): therapeutic mechanism and its associated genes. Curr Drug Targets. 2013 
Jul;14(8):872-9.
7. Yuan R, Zhang D, Yang J, Wu Z, Luo C, Han L et al. Review of aromatherapy essential 
oils and their mechanism of action against migraines. J Ethnopharmacol. 2021 Jan 
30;265:113326
8. Perry R, Terry R, Watson LK, Ernst E. Is lavender an anxiolytic drug? A systematic 
review of randomised clinical trials. Phytomedicine. 2012 Jun 15;19(8-9):825-35.
9. Wotman M, Levinger J, Leung L, Kallush A, Mauer E, Kacker A. The Efficacy of 
Lavender Aromatherapy in Reducing Preoperative Anxiety in Ambulatory Surgery 
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Patients Undergoing Procedures in General Otolaryngology. Laryngoscope Investig 
Otolaryngol. 2017 Nov 8;2(6):437-441.
10. Jaruzel CB, Gregoski M, Mueller M, Faircloth A, Kelechi T. Aromatherapy for 
Preoperative Anxiety: A Pilot Study. J Perianesth Nurs. 2019 Apr;34(2):259-264.
11. Beyliklioğlu A, Arslan S. Effect of Lavender Oil on the Anxiety of Patients Before Breast 
Surgery. J Perianesth Nurs. 2019 Jun;34(3):587-593.
12. Kim S, Kim HJ, Yeo JS, Hong SJ, Lee JM, Jeon Y. The effect of lavender oil on stress, 
bispectral index values, and needle insertion pain in volunteers. J Altern Complement 
Med. 2011 Sep;17(9):823-6.
13. Grigoleit HG, Grigoleit P. Pharmacology and preclinical pharmacokinetics of 
peppermint oil. Phytomedicine. 2005 Aug;12(8):612-6.
14. Hines S, Steels E, Chang A, Gibbons K. Aromatherapy for treatment of postoperative 
nausea and vomiting. Cochrane Database of Systematic Reviews 2018, Issue 3. Art. No.: 
CD007598. DOI: 10.1002/14651858.CD007598.pub3. Accessed 27 September 2021.
15. Ahmadi Y, Rezaei J, Rezaei M, Khatony A. Comparison of the Effect of Inhalation 
Aromatherapy with 10% and 30% Peppermint Essential Oils on the Severity of Nausea 
in Abdominal Surgery Patients. Evid Based Complement Alternat Med. 2020 Apr 
20;2020:5897465. 
16. Maghami M, Afazel MR, Azizi-Fini I, Maghami M. The effect of aromatherapy with 
peppermint essential oil on nausea and vomiting after cardiac surgery: A randomized 
clinical trial. Complement Ther Clin Pract. 2020 Aug;40:101199.
17. Grant MC, Kim J, Page AJ, Hobson D, Wick E, Wu CL. The Effect of Intravenous 
Midazolam on Postoperative Nausea and Vomiting: A Meta-Analysis. Anesth Analg. 
2016 Mar;122(3):656-663.
18. Aldrete JA, Kroulik D. A postanesthetic recovery score. Anesth Analg. 1970 Nov-
Dec;49(6):924-34.
19. Aldrete JA. Modifications to the postanesthesia score for use in ambulatory surgery. J 
Perianesth Nurs. 1998 Jun;13(3):148-55.
20.Apfel CC, Heidrich FM, Jukar-Rao S, Jalota L, Hornuss C, Whelan RP, Zhang K, 
Cakmakkaya OS. Evidence-based analysis of risk factors for postoperative nausea and 
vomiting. Br J Anaesth. 2012 Nov;109(5):742-53.

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14. Appendixes 
Calendar of Events
Data collection forms
Appendix 1: Calendar of Events
Visit Window
Screening
Intra-op
Post-op
Subject Recruitment
x
Enrollment/Pt 
education
x
Medical Record 
Documentation
x
x
x
CRF completion
x
x
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Appendix 2: Data Collection Forms
ELIGIBILITY
Study #: _____________
MRN:      _____________
Inclusion criteria
x
Adult patients (≥18 years old)
                 Yes / No
x
Undergoing Port-a-Cath placement surgery under
     Yes / No 
Monitored Anesthesia Care
x
Signed informed consent form
     Yes / No
Exclusion criteria
x
Patients undergoing other surgical procedures                                    
      Yes / No
during Port-a-Cath placement (including explantation
of a Port-a-Cath or other previous vascular access device)
x
Patients requiring general anesthesia or those not eligible for MAC       Yes / No
x
Patients allergic or sensitive to plants, essential oils, or
                  Yes / No
any of the medications used in this study
            
x
Patients with history of G6PD deficiency
       
      Yes / No
x
Patients with history of atrial fibrillation 
       Yes / No
x
Patients unable to complete study questionnaires
       Yes / No
x
Patients who are completely anosmic or who have history 
       Yes / No
of intolerance to aromatherapy
x
Patients who have been taking any opioid daily for 90 days or more        Yes / No
x
Patients who have been taking any benzodiazepine daily for 
30 days or more 
                                                                     Yes / No
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DEMOGRAPHIC AND PREOPERATIVE DATA
Study #: _________
MRN:  _____________
Age: _______________
Sex:  Female/Male
Ethnicity: (Circle all that applies)
Caucasian      Black      Hispanic     Asian.    Other
Height (cm):   ______________ Weight (kg): ____________ 
Body Mass Index (BMI) __________________________________
ASA (Circle one):  1   2   3   4
CURRENT CANCER (Circle all that applies)
Breast   Malignant bone tumor   Lung   Urological   Gastrointestinal    Head and Neck    
Genitourinary   Skin    Central nervous system    Lymphoma     Leukemia      Myeloma
Other Unknown
MEDICAL HISTORY 
Oncology History (other than primary) Yes/No 
If yes, please circle all that applies:
Breast   Malignant bone tumor   Lung   Urological   Gastrointestinal    Head and Neck    
Genitourinary   Skin    Central nervous system    Lymphoma     Leukemia      Myeloma
Other Unknown
Charlson Comorbidities 
Myocardial infarction (+1)
Congestive heart failure (+1)
Peripheral vascular disease (+1)
Cerebrovascular disease (except hemiplegia) (+1)
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Dementia (+1)
Chronic pulmonary disease (+1)
Connective tissue disease (+1)
Ulcer disease (+1)
Mild liver disease (+1)
Diabetes (without complications) (+1)
Diabetes with end-organ damage (+2)
Hemiplegia (+2)
Moderate or severe renal disease (+2)
Solid tumor (non-metastatic) (+2)
Leukemia (+2)
Lymphoma, multiple myeloma (+2)
Moderate or severe liver disease (+3)
Metastatic solid tumor (+6)
AIDS (+6)
(Check all that apply)
Comorbidity Score
__________________________________
Please select a patient age range 50 - 59 (+1)
60 - 69 (+2)
70 - 79 (+3)
80 - 89 (+4)
90 - 99 (+5)
Age Score
__________________________________
Total Charlson Comorbidities Score
__________________________________
History of Smoking (Please check appropriate box.)
□ Current smoker  
□ Quit smoking: within 30 days of surgery 
□ Quit smoking: 1 month to 1 year before surgery 
□ Quit smoking: more than 1 year before surgery 

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□ Never smoked
PREOPERATIVE ANALGESIA
Pain Intensity (Circle one): 0  1  2  3  4  5  6  7  8  9  10  N/A
(Verbal numeric rating scale: 0: no pain – 10: worst pain possible)
Preoperative Opioids Yes____No____ Prescribed since when?________
Fentanyl amount/day (mcg)  ________   (Please enter 0 if not taking)
Hydrocodone amount/day (mg) ________ (Please enter 0 if not taking)
Hydromorphone amount/day (mg) _______(Please enter 0 if not taking)
Methadone amount/day (mg) ________   (Please enter 0 if not taking)
Morphine amount/day (mg) ________   (Please enter 0 if not taking)
Oxycodone amount/day (mg) ________   (Please enter 0 if not taking)
Oxymorphone amount/day (mg) ________   (Please enter 0 if not taking)
Tramadol amount/day (mg) ________   (Please enter 0 if not taking)
Codeine amount/day (mg) ________   (Please enter 0 if not taking)
Other Opioids (Write name and dose) ____________
Preoperative Morphine Equivalent Daily Dose:________   
Preoperative NSAIDs  Yes____ N0______(Check all that apply)
Ibuprofen amount/day (mg) ________   (Please enter 0 if not taking)
Naproxen amount/day (mg) ________   (Please enter 0 if not taking)
Meloxicam amount/day (mg) ________   (Please enter 0 if not taking)
Ketorolac amount/day (mg) ________   (Please enter 0 if not taking)
Diclofenac amount/day (mg) ________   (Please enter 0 if not taking)
Celecoxib amount/day (mg) ________   (Please enter 0 if not taking)
Other preoperative NSAID (Write name and dose)
__________________________________
Preoperative Gabapentinoids Yes____ N0______(Check all that apply)
Gabapentin amount/day (mg) ________   (Please enter 0 if not taking)
Pregabalin amount/day (mg) ________   (Please enter 0 if not taking)
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Preoperative Acetaminophen Yes____ N0______
If yes, amount/day (mg) ______
Preoperative benzodiazepines Yes____No____ Prescribed since when?______
Diazepam amount/day (mg) ________   (Please enter 0 if not taking)
Alprazolam amount/day (mg) ________   (Please enter 0 if not taking)
Triazolam amount/day (mg) ________   (Please enter 0 if not taking)
Lorazepam amount/day (mg) ________   (Please enter 0 if not taking)
Clonazepam amount/day (mg) ________   (Please enter 0 if not taking)
Midazolam amount/day (mg)___________(Please enter 0 if not taking)
Preoperative antiemetics
Ondansetron amount/day (mg)  ________   (Please enter 0 if not taking)
Granisetron amount/day (mg) ________ (Please enter 0 if not taking)
Aprepitant amount/day (mg) _______(Please enter 0 if not taking)
Promethazine amount/day (mg) ________   (Please enter 0 if not taking)
Droperidol amount/day (mg) ________   (Please enter 0 if not taking)
Metoclopramide amount/day (mg) ________   (Please enter 0 if not taking)
Scopolamine patch amount/day (mg) ________   (Please enter 0 if not taking)
Apfel-Score for PONV
Gender                 
Male 0 / Female: +1
Smoking status     
Smoker 0 / Non-smoker
+1
History of motion sickness or PONV
No 0
/ Yes +1
Use of postoperative Opioids 
No: 0    /   Yes  +1
Total points:_______    

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HOSPITAL ANXIETY AND DEPRESSION SCALE
Study#: _________________
MRN:    _________________
Tick the box beside the reply that is closest to how you have been feeling in the 
past week. Don’t take too long over your replies: your immediate is best.
1.
I feel tense or 'wound up' 
o
Not at all
o
From time to time, occasionally
o
A lot of the time
o
Most of the time
2. I get a sort of frightened feeling as if something awful is about to happen.
o
Not at all
o
A little but it doesn't worry me
o
Yes, but not too badly
o
Very definitely and quite badly
3. Worrying thoughts go through my mind 
o
Only occasionally
o
From time to time, but not too often
o
A lot of the time
o
A great deal of the time
4. I can sit at ease and feel relaxed 
o
Definitely
o
Usually
o
Not Often
o
Not at all
5. I get a sort of frightened feeling like 'butterflies' in the stomach.
o
Not at all
o
Occasionally
o
Quite Often
o
Very Often
6. I feel restless as I have to be on the move.
o
Not at all
o
Not very much
o
Quite a lot
o
Very much indeed
7. I get sudden feelings of panic.
o
Not at all
o
Not very often
o
Quite often
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o
Very often indeed
8. I still enjoy the things I used to enjoy.
o
Definitely as much
o
Not quite as much
o
Only a little
o
Hardly at all
9. I can laugh and see the funny side of things as much as I always could.
o
Not quite so much now
o
Definitely not so much now
o
Not at all
10. I feel cheerful.
o
Most of the time
o
Sometimes
o
Not often
o
Not at all
11. I feel as if I am slowed down.
o
Not at all
o
Sometimes
o
Very often
o
Nearly all the time
12. I have lost interest in my appearance.
o
I take just as much care as ever
o
I may not take quite as much care
o
I don't take as much care as I should
o
Definitely
13. I look forward with enjoyment to things.
o
As much as I ever did
o
Rather less than I used to
o
Definitely less than I used to
o
Hardly at all
14. I can enjoy a good book or radio or TV program.
o
Often
o
Sometimes
o
Not often
o
Very seldom

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SEDATION AND INTRAOPERATIVE DATA
Study #: _____________
MRN:     _____________
Randomization:  Active treatment / placebo
Date of Surgery. ___/___/___
Procedure Start Time: ______:_____. Procedure End Time: ______:______. 
Duration of Surgery (min): _______. 
Sedation
Sedation Start Time (placement of patch): ______:_____. 
Sedation End Time (removal of patch): ______:______. 
Duration of sedation (min): _______. 
Midazolam given:   Yes / No      If yes: total dose (mg): ______
Analgesia
Intraoperative Acetaminophen:  Yes / No      If yes: total dose (mg): ____
Intraoperative Opioids
Fentanyl: Yes / No      If yes: total dose (mg): ____
Hydromorphone: Yes / No      If yes: total dose (mg): ____
Other (Name and dose): ______________ 
Rescue antiemetics
Dexamethasone: Yes / No  If yes: total dose (mg): ____
Ondansetron: Yes / No       If yes: total dose (mg): ____.      
                                
Granisetron: Yes / No         If yes: total dose (mg): ____
Promethazine: Yes / No      If yes: total dose (mg): ____
Propofol: Yes / No                If yes: total dose (mg): ____
Any AE/SAE: __________ 
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POSTOPERATIV DATA – PACU
Study #: ______________
MRN:     ______________
Time of admission to PACU: ______/________
Time of discharge from PACU: ______/________
Verbal numerical Pain Score, Aldrete Parsap Recovery Score, nausea intensity and 
the number of vomiting episodes are recorded every 15 minutes from Anesthesia 
end until a Parsap Score ≥ 18 is reached. Patient Satisfaction is assessed as soon as 
a Parsap Score ≥18 has been reached. 
Aldrete Parsap Recovery Score
Indices
Task
Score
Activity
Able to move four extremities voluntarily or on command
Able to move two extremities voluntarily or on command
Unable to move extremities voluntarily or on command
2
1
0
Respiration
Able to breathe deeply and cough freely
Dyspnea, limited breathing or tachypnea
Apneic or on mechanical ventilator
2
1
0
Circulation
BP ± 20% of pre-anesthetic level
BP ± 20 - 49% of pre-anesthetic level
BP ± 50% of pre-anesthetic level
2
1
0
Consciousness
Fully awake
Arousable on calling
Not responding
2
1
0
O2 Saturation
Able to maintain O2 saturation > 92% on room air
Needs O2 inhalation to maintain O2 saturation > 90%
O2 saturation <90% even with O2 supplement
2
1
0
Dressing
Dry and clean
Wet but marked and not increasing
Growing area of wetness
2
1
0
Pain
Pain free
Mild pain handled by oral medication
Severe pain requiring parenteral medication
2
1
0
Ambulation
Able to stand up and walk straight
Vertigo when erect
Dizziness when supine
2
1
0
Fasting-Feeding
Able to drink fluids
Nauseated
Nausea and vomiting
2
1
0
Urine Output
Has voided
Unable to void but comfortable
Unable to void and uncomfortable
2
1
0
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T1: ______/________ Score: ________
T2: ______/________ Score: ________ if patient is still admitted to PACU
T3: ______/________ Score: ________ if patient is still admitted to PACU
T4: ______/________ Score: ________ if patient is still admitted to PACU
T5: ______/________ Score: ________ if patient is still admitted to PACU
T6: ______/________ Score: ________ if patient is still admitted to PACU
T7: ______/________ Score: ________ if patient is still admitted to PACU
T8: ______/________ Score: ________ if patient is still admitted to PACU
T9: ______/________ Score: ________ if patient is still admitted to PACU
T10: ______/________ Score: _______  if patient is still admitted to PACU
Pain intensity (VNRS, 0: no pain – 10: worst pain possible)
T1: ______/________ Score: ________
T2: ______/________ Score: ________ if patient is still admitted to PACU
T3: ______/________ Score: ________ if patient is still admitted to PACU
T4: ______/________ Score: ________ if patient is still admitted to PACU
T5: ______/________ Score: ________ if patient is still admitted to PACU
T6: ______/________ Score: ________ if patient is still admitted to PACU
T7: ______/________ Score: ________ if patient is still admitted to PACU
T8: ______/________ Score: ________ if patient is still admitted to PACU
T9: ______/________ Score: ________ if patient is still admitted to PACU
T10: ______/________ Score: _______  if patient is still admitted to PACU
Postoperative Analgesics
Acetaminophen: Yes / No If yes dose (mg)____ route: po/iv
NSAIDs 
Celecoxib: Yes / No If yes dose (mg)____ route: po/iv___time first dose:___:___
Ketorolac: Yes / No If yes dose (mg)____ route: po/iv
Ibuprofen: Yes / No If yes dose (mg)____ route: po/iv
Naproxen: Yes / No If yes dose (mg)____ route: po/iv
Other: Yes / No If yes dose (mg)____ route: po/iv
Postoperative Opioids 
Fentanyl: Yes / No If yes dose (mg)____ route: po/iv___time first dose:___:___
Hydromorphone: Yes / No If yes dose (mg)____ route: po/iv___time first dose:___:___
Morphine: Yes / No If yes dose (mg)____ route: po/iv___time first dose:___:___
Hydrocodone: Yes / No If yes dose (mg)____ route: po/iv___time first dose:___:___
Tramadol: Yes / No If yes dose (mg)____ route: po/iv___time first dose:___:___
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Oxycodone: Yes / No If yes dose (mg)____ route: po/iv___time first dose:___:___
Codeine: Yes / No If yes dose (mg)____ route: po/iv___time first dose:___:___
Other: Yes / No If yes dose (mg)____ route: po/iv___time first dose:___:___
Nausea intensity (VNRS, 0: no nausea – 10: worst nausea possible)
T1: ______/________ Score: ________
T2: ______/________ Score: ________ if patient is still admitted to PACU
T3: ______/________ Score: ________ if patient is still admitted to PACU
T4: ______/________ Score: ________ if patient is still admitted to PACU
T5: ______/________ Score: ________ if patient is still admitted to PACU
T6: ______/________ Score: ________ if patient is still admitted to PACU
T7: ______/________ Score: ________ if patient is still admitted to PACU
T8: ______/________ Score: ________ if patient is still admitted to PACU
T9: ______/________ Score: ________ if patient is still admitted to PACU
T10: ______/________ Score: _______  if patient is still admitted to PACU
Vomiting: Yes / No Time of first occurrence of vomiting. ____:______
Vomiting episodes
T1: ______/________ Number: ________
T2: ______/________ Number: ________ if patient is still admitted to PACU
T3: ______/________ Number: ________ if patient is still admitted to PACU
T4: ______/________ Number: ________ if patient is still admitted to PACU
T5: ______/________ Number: ________ if patient is still admitted to PACU
T6: ______/________ Number: ________ if patient is still admitted to PACU
T7: ______/________ Number: ________ if patient is still admitted to PACU
T8: ______/________ Number: ________ if patient is still admitted to PACU
T9: ______/________ Number: ________ if patient is still admitted to PACU
T10: ______/________Number: _______  if patient is still admitted to PACU
Ondansetron: Yes / No If yes: dose (mg)____ route: po/iv___time first dose:___:___
Granisetron: Yes / No If yes: dose (mg)____ route: po/iv___time first dose:___:___
Promethazine: Yes / No If yes: dose (mg)____ route: po/iv___time first dose:___:___
Other:______ Yes / No If yes: dose (mg)____ route: po/iv___time firstdose:___:___
Likert Scale for patient satisfaction (circle one)
Satisfaction level
Score
Very much satisfied
5
Somewhat satisfied
4
Undecided
3
Not really satisfied
2
Not at all satisfied
1
Proprietary of MD Anderson Cancer Center

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There are no screening tests or blood draws require to enter the study. 
We expect 70 patients here at MD Anderson Cancer Center to agree and participate in the 
study.
Prior to surgery, subjects will be randomized 1:1 to either a lavender/peppermint patch of 
Elequis Aromatabs®, or a matching placebo patch.