Clinical trial NCT02882854
Conditions: Postoperative Nausea and Vomiting Pain, Postoperative
Sponsor: Vanderbilt University Medical Center
Start date: 2016-11-01; Completion date: 2017-02-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Postoperative nausea and vomiting (PONV) and pain are the most common causes of Post Anesthesia Care Unit (PACU) discharge delay, with untreated PONV occurring in 20-30% of post-surgical patients. The effect of guanfacine (GF) administration on pain and nausea scores will be assessed with two groups. One group will receive 1 mg of GF to take orally and the other group will receive a similar appearing placebo (containing no drug) to take orally.

Detailed description:
Pain after surgery is commonly treated with narcotics which can potentiate PONV, further delaying PACU discharge. In multiple studies, alpha-2 agonists such as clonidine and dexmedetomidine reduce both the incidence of PONV and post-op pain, as well as requirements for postoperative analgesics. These actions are mediated via central alpha-2A receptors (A2AR). Of the A2AR agonists, guanfacine, though a weak antihypertensive agent, has the highest selectivity for the A2AR, but to date is untested for its potential to treat either PONV or post-operative pain.

Arms: arm 1: Guanfacine 1 mg capsule by mouth, one time prior to surgery. arm 2: Placebo with a similar appearance to guanfacine by mouth one time prior to surgery
Interventions: intervention 1: Guanfacine intervention 2: Placebo
Intervention descriptions: intervention 1: Patients will receive 1 mg of guanfacine to take orally. intervention 2: Patients will receive a placebo containing no drug that appears similarly to guanfacine to take orally.

Protocol documents:
Prot_SAP_000.pdf: 
1 
 
Guanfacine for PONV and Pain  
After Sinus Surgery 
Version: March 10, 2016 
NCT #: NCT02882854 
 
Principal Investigator:  Stephen Harvey, MD 
Assistant Professor 
Department of Anesthesiology 
 Vanderbilt University Medical Center 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Department of Anesthesiology 
Vanderbilt University Medical Center 
 
 
 


2 
 
Table of Contents: 
 
Study Schema 
 
Abstract 
 
1.0 
Background 
 
2.0 
Rationale and Specific Aims 
 
3.0 
Inclusion/Exclusion Criteria 
 
4.0 
Enrollment/Randomization 
 
5.0 
Study Procedures 
 
6.0 
Risks of Investigational Agents (side effects) 
 
7.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk to Participants or 
Others 
 
8.0 
Study Withdrawal/Discontinuation 
 
9.0 
Privacy/Confidentiality Issues 
 
10.0 
Follow-up  
 
11.0 
Record Retention 
 
12.0 
References 
 
13.0 
Testing Regimens 
 
14.0 
Data Dictionary 
 
15.0 
Patient Data Sheet 
 
 
 
 
 
 
 


3 
 
 
STUDY SCHEMA 
PRE-OP 
SURGERY 
EMERGE 
PACU  
Consent 
Tot GA time 
    Extubate 
Max nVRS 
Demographics 
#pressors 
   Transport 
PONV Tx 
Study Drug/placebo 
 
 
Max pVAS 
 
 
 
Total ME 
 
 
 
PACU LOS 
 
After meeting I/O criteria pre-operatively, patients will hear a brief description of the study (guanfacine for PONV). 
If they are interested, potential participants will be given a consent to read and ask questions. After all their questions 
have been answered, they will sign the consent if they wish to participate. Study drug will be administered with a few 
sips water. IV pre-med should consist of no more than 2 mg midazolam.  
 
Total time under general anesthesia (induction to extubation) will be recorded along with the number of times pressors 
are administered.  No non-depolarizing muscle relaxant will be administered to avoid the need for reversal agents and 
the associated confounding factor. 
 
In PACU, the maximum nausea score (nVRS) 0-10 will be recorded, where 0 = none and 10 = maximum, along with 
the number of times an anti-emetic is required.  Maximum pain score (VAS) along with morphine equivalents will 
also be recorded.  PACU length of stay (LOS) will also be recorded. PACU times may be obtained from the PACU 
records. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


4 
 
Abstract 
Postoperative nausea and vomiting (PONV) and post-op pain are the most common problems after 
all types of surgery and the two major factors delaying post-anesthesia care unit (PACU) discharge.  
PONV has an incidence of 20-30% if untreated. Pain after surgery is commonly treated with 
narcotics which can potentiate PONV, further delaying PACU discharge. In multiple studies, 
alpha-2 agonists such as clonidine and dexmedetomidine reduce both the incidence of PONV and 
post-op pain, as well as requirements for postoperative analgesics. These actions are mediated via 
central alpha-2A receptors (A2AR). Of the A2AR agonists, guanfacine (GF), though a weak 
antihypertensive agent, has the highest selectivity for the A2AR, but to date is untested for its 
potential to treat either PONV or post-op pain. In this double blind, placebo-controlled study, we 
will evaluate oral guanfacine versus placebo in patients undergoing sinus surgery for its potential 
to reduce PONV and pain in the PACU.  
 
Background 
Postoperative nausea and vomiting (PONV) and pain are the most common causes of Post 
Anesthesia Care Unit (PACU) discharge delay, with untreated PONV occuring in 20-30% of post-
surgical patients. 1  In addition to the immediate discomfort, patients who suffer with these 
symptoms may develop maladaptive behavioral changes. Furthermore, managing PONV and pain 
increases PACU staffing requirements and the direct cost of care.  
Because of the published efficacy of alpha-2 agonists in reducing PONV and pain, 
anesthesiologists at Vanderbilt University Medical Center commonly employ oral, generic off-
label guanfacine (GF) pre-operatively with a perceived reduction in these symptoms.  
1.0 
Rationale and Specific Aims 
In efforts to improve the postoperative course of their patients, anesthesiologists have administered 
several medications with mixed results. Propofol, ketamine, lidocaine, and opioids have been 
shown to have varying effects in reducing (and sometimes increasing) PONV and pain in the 
PACU. Over the last few years, alpha-2 adrenergic receptor (A2-AR) agonists have gained 
popularity as effective agents for reducing these symptoms.  By more selectively targeting the 
A2AR, Dexmedetomidine (DEX) reduces PONV, pain and anxiety with greater hemodynamic 
stability, but at significantly greater cost. Guanfacine (GF) is the oldest A2-AR agonist in clinical 
use in this class and the least expensive (10₵/mg). Also, GF is the most highly selective for the 


5 
 
alpha-2A receptor subtype 2 and the least sedating. 3 GFs effects on PONV and pain are unstudied, 
but it has been used orally for more than 35 years for hypertension, and more than 20 years for 
managing ADHD. 4  
2.1  
PONV 
In preventing PONV, 5 the mechanism of the A2-AR agonists is not perfectly clear, though both 
CL and DEX have vagolytic, anti-dysrhythmic effects 6 as well as concomitant anti-sialagogue 
and airway drying actions. These effects likely arise from brainstem actions at A2-AR in the dorsal 
motor nucleus of the vagus, the area postrema, and the nucleus tractus solitarius. 7 
2.2    
Pain 
Both CL and DEX are well studied for pain management, with actions on brainstem and spinal 
dorsal horn A2-AR. Mechanisms 2 include a reduction of central sensitization and upregulation of 
NO synthase. 8 Furthermore, as a result of the presence and similarity of mu opioid and A2-AR 
(both Gi/o GPCRs) in locus coeruleus, cross reactivity of the natural ligands at these receptors in 
LC likely confers (via GIRK channels) the A2-AR descending central analgesic effects. 9 
2.4       Previous Studies  
Zhao, et al., 18 recently studied 90 patients, 30/group, undergoing thyroidectomy and receiving 
intraoperative infusions of either 0.4 or 0.8 mcg/kg/hr DEX vs placebo. The DEX groups had ~1-
3-fold lower pain scores (VAS: 0.4 group: 1.50+/-0.52; 0.8 Group: 0.80+/-0.63 vs. Placebo 2.50+/-
0.52) in the PACU, as well as a substantially lower incidence of PONV (0.4 Group: 3.3%; 0.8 
Group: 0%; Placebo: 13.3%). In a systematic review and meta-analysis of 30 studies of 
perioperative A2-AR agonist use (aggregate 1,792 pts, 933 receiving DEX or clonidine), 
Blaudszun et al. validated the use of alpha-2 agonists in the reduction of postoperative pain (and 
reduced opioid requirements) and PONV at one hour, without prolonging PACU times. 19 
Tufanogullari et al. also showed that dexmedetomidine reduced total morphine equivalents as well 
as nausea based on an 11-point verbal rating scale (VRS). 
The effectiveness of GF in reducing Post-op pain and PONV has never been studied. However, 
since GF is the most selective A2-AR agonist in clinical use, we believe the reduction of 
postoperative pain and PONV seen with clonidine and dexmedetomidine can be reproduced (and 
potentially surpassed) with GF.  
 


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2.5       Hypothesis  
As a primary endpoint, we hypothesize that patients undergoing a standardized general anesthetic 
for sinus surgery and are randomized to receive GF vs Placebo will have 20-30% lower PONV 
scores in PACU, as measured by the 10-point nausea scale (nVRS) previously used in other 
studies. Secondarily, we hypothesize that patients receiving GF will have less pain as measured by 
visual/verbal analog (VAS) scores and total morphine equivalents (ME) administered in PACU 
than patients receiving placebo, without significant hemodynamic instability. 
3.0 
Inclusion/Exclusion Criteria 
3.1  
Inclusion Criteria 
 VUMC patients undergoing sinus surgery in MCE OR. 
 Adults aged 18 and older 
 
3.2   
Exclusion Criteria 
 Patients who do not meet the inclusion criteria  
 Inability to read and freely consent 
 Patients who take alpha-2 agonists routinely (guanfacine, clonidine, tizanidine)  
 Patients undergoing sinus surgery planned for greater than 3 hours 
 Patients with significant pre-existing pain, on chronic pain (opioid, methadone) 
therapy, severe fibromyalgia or other pre-existing pain condition in any body part  
 Patients with pre-op nausea/vomiting at baseline. 
 Pregnant or lactating women. 
 
4.0 
Enrollment 
Patients identified as candidates by primary criteria (above inclusion/exclusion listing) will be 
interviewed immediately prior to surgery to determine suitability and patient willingness to 
participate in the study. After receiving complete information and a description of the study, 
patients accessioned will give written consent. On pre-op administration, Pt. Name, MRN and 
Study Drug Envelope Number (SDE#) will be logged into the Study Database in REDCap and 
reported directly to IPS with a completed Study Drug Administration Sheet, either by hand or by 
FAX.  
 


7 
 
 
5.0      Study Procedures  
5.1 
Statistical Analysis and Power 
The effect of guanfacine administration on pain and nausea scores will be assessed using 
proportional odds logistic regression. The odds of greater pain or nausea associated with 
guanfacine administration will be summarized using the odds ratio and Wald-type 95% 
confidence interval and Wald test against the null hypothesis of no effect (odds ratio equal to 
one). 
 
The study design and testing procedure were simulated to study the statistical power. The 
distribution of pain and nausea scores in the placebo and guanfacine groups were assumed to 
have the distributions illustrated in the figure below, which correspond to a difference in mean 
score of 1.5 points, or an (ordinal) odds ratio of 0.25. Taking this as the minimum detectable 
effect, 80 randomized subjects are needed to achieve 90% power. 
 
 
 
 
 
 
 
 


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5.2 
RANDOMIZATION 
Subjects will be randomized to one of TWO GROUPS: Group A: Forty (40) patients will receive 
GF 1 mg orally; OR, Group B: Forty (40) patients will receive a similar appearing placebo 
(containing no drug) from numbered study drug envelopes (SDE) prepared by Vanderbilt’s 
Investigational Pharmacy Service (IPS) which will independently randomize the drug envelopes 
and maintain the Master Drug Study Log. 
 
5.3 
POWER ANALYSIS 
5.4      STUDY METHODS  
 
5.41 
PRE-OP 
 
 
a. Consent; Demographics; 25 
b. NO PRE-OP ADJUNCTS  
Ketamine, gabapentin, acetaminophen, droperidol, promethazine, haloperidol, other 
buterophenones or phenothiazines will not be administered.  
 
5.42      ANESTHESIA MANAGEMENT  
The general anesthetic administered will be standardized as follows: 
a. Premedication: Midazolam 0 - 2 mg IV  
b. Induction: Fentanyl: 0.5-2 mcg/kg; Lidocaine: 1-2 mg/kg; Propofol: 1-
3 mg/kg; SUX: 0.5-1.5 mg /kg 
c. Maintenance: with inhalational agent and hydromorphone.  
d. Emergence: Hydromorphone in 0.25 mg increments as deemed 
appropriate by anesthesia team and a standardized dose of ondansetron 
(4 mg) in keeping with routine practice. 
5.43 
PACU: Hydromorphone for pain and ondansetron for PONV per 
standardized order set will be administered and documented. IV fluids and oxygen may be 
continued as long as deemed useful by the PACU and Study staff. 
5.5      POST-OP: 
A. PONV will be quantified by the maximum nVRS.   
B. PAIN will be evaluated by the maximum Verbal Analog Scale (VAS = 
0 – 10: See Fig. 6). 
C. PACU LOS will be the duration of PACU Length of Stay 


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5.6      DATA COLLECTION (See Data Sheet and Data Dictionary) 
A. STANDARD ANESTHESIA PRE-OP ASSESSMENT 
B. ANESTHESIA RECORD COPY  
C. COPY OF SIGNED PATIENT CONSENT FOR STUDY 
D. PATIENT DATA SHEET, (PDS) including Transition Times: 
1. Planned Surgical Procedure, Duration 
2. Demographics (age, height, weight, etc.)  
3. Nausea score (nVRS) and rescue Tx in PACU  
4. Pain Scores (VAS) and Tx in PACU 
5. PACU LOS  
5.7      STUDY CONDUCT: 
5.71  PRE-OP: After soliciting interest and enrolling, written consent will be 
obtained and basic patient data and pre-op assessments (Apfel Score Fig 2) performed. 
Patients will receive GF or placebo orally from a numbered envelope prepared by the IPS 
in a blinded manner. Patients will then undergo a standardized general anesthetic as 
described above. At the conclusion of the sinus procedure, patients will be extubated as per 
routine management and assessed immediately with:  
 
5.72  In PACU, assess the following endpoints: 
A. Max Nausea score (nVRS) 
B. PONV Treatment(s) 
C. VAS (Fig 6): Assess Pain score (Verbal Analog Scale rated 1-10) at 10 
and 60 min after PACU arrival 
D. Pain TX: Total Narcotic requirement in PACU (Tallied in Morphine 
Equivalents for PACU stay) 
E. PACU LOS 
 
6.0      RISKS 
Both PONV and post-op pain are expected risks after surgery. The risk of the use of GF include 
modest hypotension and sedation. Coincident to the study, patients will be undergoing sinus 


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surgery, but there will be no medical procedures performed on patients as part of the study. To 
protect the patient’s confidentiality, only a limited data set will be created. The PI will check the 
data for completeness after it’s been collected/extracted/collated and verify that all subject 
identifiers except those listed in the limited data set are destroyed once the study is concluded. All 
data will be stored on a password-protected server in a locked area of the VUMC Department of 
Anesthesiology.  This data will only be accessible by the PI and KSP. 
 
7.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk to 
Participants or Others 
Adverse events will be monitored throughout the study.  These may include any occurrence within 
the study setting (surgery itself or the conduct of the anesthetic), such as unexplained changes in 
vital signs, unexpected surgical complications, prolonged PACU stay, etc. Protocol deviations will 
be reported separately per VHRPP guidelines. The PI of this study will report adverse events to 
the IRB per VHRPP reporting guidelines. 
 
8.0 
Study Withdrawal/Discontinuation 
8.1 Withdrawal. After Study Drug administration, this study involves only assessment for 
nausea and vomiting (nVRS) and pain (VAS) in the surgical setting of sinus surgery. After patients 
have been enrolled and consented, it is not anticipated that patients will voluntarily withdraw. 
Nevertheless, patients are free to withdraw at any time, simply by telling one of the study 
physicians/managers. However, after enrollment and initial pre-op study assessment, patients may 
withdraw up to the point of anesthetic induction and surgical procedure, and thereafter, may only 
withdraw when fully awake and alert in PACU. 
 
8.2 Discontinuation.  This study is designed as intention-to-treat, so once subjects have 
taken the Study Drug, they will be followed per protocol through completion, or up to any time 
they choose to withdraw or any unspecified Adverse Event that would halt normal data collection. 
In either event, data obtained to that point in the protocol would be included in the total dataset, 
with reporting of the withdrawal or AE as noted above.  
 
 
 


11 
 
9.0 
Privacy/Confidentiality Issues 
All reasonable efforts will be made to keep a patient’s protected health information (PHI) private 
and confidential.  Patients will be assigned a code to replace names.  There will be limited access 
to medical records and a limited data set created.  Federal privacy guidelines will be followed 
when using or sharing any protected health information.  
Data will be stored in secured areas on password protected Vanderbilt PCs conforming to the latest 
Vanderbilt IS security policies. Computer databases will be maintained on password protected 
Vanderbilt PCs. REDCap (see below) servers are housed in a local data center at Vanderbilt, and 
all web-based information transmission is encrypted. REDCap was developed specifically around 
HIPAA-Security guidelines and is recommended to Vanderbilt researchers by both our Privacy 
Office and Institutional Review Board. All study staff have completed employee education 
regarding patient confidentiality and have completed Human Subjects protection education (CITI 
course) as specified by the VHRPP. 
10.0 
Follow-up  
The Perioperative Clinical Research Institute (PCRI) will retain research Records for a period of 
six (6) years after the submission of the final report and closeout procedures on the research project 
for which the Research Records were prepared. Paper copies of the research records and/or 
research consent will be held in a secure access area determined by of the Department of 
Anesthesia (PCRI) for 6 years. Any research data that is put in the participants medical record will 
be kept for an unknown length of time.   
 
11.0 
 Record Retention & Data Management  
The retention of the original Research Records will be the responsibility of the Principal 
Investigator on behalf of PCRI, but at all times shall remain the property of PCRI, unless otherwise 
specified by law, regulation or agreement.  The Vanderbilt University Office of Research will be 
used as a central location for data processing and management. Vanderbilt University, with 
collaboration from a consortium of institutional partners, has developed a software toolset and 
workflow methodology for electronic collection and management of research and clinical trial 
data. REDCap (Research Electronic Data Capture) is a secure, web-based application that is 


12 
 
flexible enough to be used for a variety of types of research. REDCap provides an intuitive user 
interface that streamlines project development and improves data entry through real-time 
validation rules (with automated data type and range checks). REDCap also provides easy data 
manipulation (with audit trails for reporting, monitoring and querying patient records) and an 
automated export mechanism to common statistical packages (SPSS, SAS, Stata, R/S-Plus). In 
addition to traditional data capture functionality, all data collection projects rely on a thorough, 
study-specific data dictionary, defined by all members of the research team in an iterative, self-
documenting process. This iterative development and testing process results in a well-planned and 
individualized data collection strategy. 
 
12.0 
References 
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Evidence from published data. Br J Anaesth. 2002;89(3):409-423. 
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Connor DF, Arnsten AF, Pearson GS, Greco GF. Guanfacine extended release for the treatment 
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Massad IM, Mohsen WA, Basha AS, Al-Zaben KR, Al-Mustafa MM, Alghanem SM. A balanced 
anesthesia with dexmedetomidine decreases postoperative nausea and vomiting after laparoscopic 
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Kamibayashi T, Hayashi Y, Mammoto T, Yamatodani A, Sumikawa K, Yoshiya I. Role of the 
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dysrhythmias in dogs. Anesthesiology. 1995;83(5):992-999. 
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Unnerstall JR, Kopajtic TA, Kuhar MJ. Distribution of alpha 2 agonist binding sites in the rat and 
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Giovannoni MP, Ghelardini C, Vergelli C, Dal Piaz V. Alpha2-agonists as analgesic agents. Med 
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Aghajanian GK, Wang YY. Common alpha 2- and opiate effector mechanisms in the locus 
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Wang M, Gamo NJ, Yang Y, et al. Neuronal basis of age-related working memory decline. 
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Arnsten AF, Jin LE. Guanfacine for the treatment of cognitive disorders: a century of discoveries 
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18. 
Zhao X, Tong D, Long B, Wu X. [Effects of different doses of dexmedetomidine on the recovery 
quality from general anesthesia undergoing thyroidectomy]. Zhonghua Wei Zhong Bing Ji Jiu Yi 
Xue. 2014;26(4):239-243. 
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Blaudszun G, Lysakowski C, Elia N, Tramer MR. Effect of perioperative systemic alpha2 
agonists on postoperative morphine consumption and pain intensity: systematic review and meta-
analysis of randomized controlled trials. Anesthesiology. 2012;116(6):1312-1322. 
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Lin TF, Yeh YC, Lin FS, et al. Effect of combining dexmedetomidine and morphine for 
intravenous patient-controlled analgesia. Br J Anaesth. 2009;102(1):117-122. 
21. 
Gurbet A, Basagan-Mogol E, Turker G, Ugun F, Kaya FN, Ozcan B. Intraoperative infusion of 
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14 
 
 
 
13.0 
Testing Regimens 
 
Fig 3. Verbal/Visual Analog Pain Score (VAS) 29:  
NO PAIN ------------------------------------------------------------------------------------WORST PAIN 
 
   0-------1-------2-------3-------4-------5-------6-------7-------8-------9-------10 
  At 10, 30, and 60 min after PACU arrival ask patient to verbally score their pain on this scale. 
 
 
 
Data Dictionary- 
1. Patient Data Sheet, (PDS) will include all data collected on each individual: 
A. Planned Surgical Procedure (all sinus surgeries not greater than 3 hours)  
B. Demographics: Data identifying characteristics of each patient, including 
Age, Gender, Height, Weight, MRN, etc.)  
2. POST-OP: 
A. Anesthetic Duration – Difference between induction and extubation recorded in the 
Anesthesia Record; PACU Entry Time 
B. PONV will be quantified by a Nausea Verbal Reporting Scale (nVRS), 0-10 
C. PAIN will be evaluated by Verbal Analog Scale (VAS = 0 – 10). (See Fig. 3)  
D. PACU LOS