Clinical trial NCT05328973: Intraoperative Aromatherapy Versus Placebo for Port-a-Cath Placement Under Monitored Anesthesia Care. A Randomized Controlled Trial
Official title: Intraoperative Aromatherapy Versus Placebo for Port-a-Cath Placement Under Monitored Anesthesia Care. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer Pain
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a prospective, controlled, randomized trial. Primary objective is 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. 70 Eligible subjects will be identified from within the patient population of the study site. There will be no advertisements for study subjects.

Detailed description: 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 Objective:

To evaluate the following secondary outcomes:

* Anxiety score (HADS) in preoperative holding area
* Midazolam use intraoperatively (mg)
* Itraoperative opioid use (morphine equivalents)
* Intraoperative anti-emetic use
* Time to first occurrence of postoperative nausea or vomiting (PONV) in PACU
* Rate and intensity of PONV in PACU
* Antiemetic use in PACU
* Opioid use in PACU (morphine equivalents)
* Pain intensity in PACU (0-10 numerical rating scale)
* Patient satisfaction in PACU

Eligibility criteria: Inclusion Criteria:

* Adult patients (≥ 18 years old)
* Port-a-Cath placement under Monitored Anesthesia Care
* Signed informed consent

Exclusion Criteria:

* Patients undergoing other surgical procedures during Port-a-Cath placement (including explantation of a Port-a-Cath or other previous vascular access device)
* Patients requiring general anesthesia or those not eligible for MAC

Primary outcomes:
measure: 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
timeFrame: from "PACU arrival" to "PACU discharge ready", 1.5 hrs in average
Secondary outcomes:
measure: Anxiety Score (HADS) in Preoperative Holding Area
timeFrame: From "In preop" to "Preop end" per EMR. 1hr in average
measure: Midazolam Use Intraoperatively (mg)
timeFrame: From "Anesthesia Start" to "Anesthesia End". 1hr in average
measure: Opioid Use Intraoperatively (in MEDD)
timeFrame: From "Anesthesia Start" to "Anesthesia End". 1hr in average
measure: Intraoperative Anti-emetic Use
timeFrame: From "Anesthesia Start" to "Anesthesia End". 1hr in average
measure: Number of Participants With Postoperative Nausea or Vomiting (PONV) in PACU
timeFrame: From "PACU Start" to "PACU Discharge", 1.5 hr in average
measure: Rate and Intensity of PONV in PACU
timeFrame: From "PACU Start" to "PACU Discharge", 1.5 hr in average
measure: Anti-emetic Use in PACU
timeFrame: From "PACU Start" to "PACU Discharge", 1.5 hr in average
measure: Opioid Use in PACU
timeFrame: From "PACU Start" to "PACU Discharge", 1.5 hr in average
measure: Pain Intensity in PACU (0-10 Numerical Rating Scale)
timeFrame: From "PACU Start" to "PACU Discharge", 1.5 hr in average
measure: Patient Satisfaction in PACU
timeFrame: From "PACU Start" to "PACU Discharge", 1.5 hr in average
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Neil Bailard, MD
role: PRINCIPAL_INVESTIGATOR
References: