Cannabidiol Oil Extract for Prevention of Postoperative Nausea and Vomiting

November 16, 2023 updated by: The University of The West Indies

Sublingual Cannabidiol Oil Extract for Prevention of Postoperative Nausea and Vomiting in Elective Gynaecological Patients at the University Hospital of the West Indies (UHWI)

Cannabidiol oil has been shown to be effective in treating chemotherapy induced nausea and vomiting, but there is limited information on its usefulness in nausea and vomiting that can occur after surgery. The goal of this study is to determine the effect of Cannabidiol oil on the frequency of nausea and vomiting in the first 24 hours after a gynaecological procedure. Other effects that will be assessed will include:

  1. The effect of Cannabidiol oil on the level of pain and amount of pain medications needed in the first 24 hours after a gynaecological operation.
  2. The effect of Cannabidiol oil on patients' overall satisfaction with the anaesthetic experience.

Some participants will be administered Cannabidiol oil under the tongue two to three hours before their procedure and an equal number will receive a placebo oil, similar in taste. This will be done randomly to minimise introducing bias. We will then compare both groups in the postoperative period to see if the Cannabidiol oil made any difference.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The overall aim of this study is to evaluate the effect of Cannabidiol oil on postoperative nausea and vomiting in elective gynaecological surgical patients undergoing general anaesthesia at the University Hospital of the West Indies, Jamaica and to determine if total analgesic requirements are reduced in the intervention group in the first 24 hours.

Primary Objective:

To compare the incidence of postoperative nausea and vomiting in gynaecological patients who receive 5.5mg of Cannabidiol oil sublingually two to three hours preoperatively to those receiving a placebo in adult elective gynaecological surgical patients.

Secondary Objectives:

  • To compare the total amount of rescue anti-emetic medications administered in the first 24 hours postoperatively between the group receiving Cannabidiol oil and the placebo group.
  • To compare total analgesic requirements in the first 24 hours postoperatively between those receiving Cannabidiol oil and the placebo group.
  • To compare the level of patient satisfaction with the overall anaesthetic experience between the intervention group and the placebo group.

We propose to use a dose of 5.5mg sublingually based on studies which have demonstrated the effectiveness of these for chemotherapy induced vomiting. As there are numerous factors which may affect postoperative nausea and vomiting, including sex, type of surgery and degree of postoperative pain, we will include only female patients undergoing gynaecological surgery to minimise these confounding factors. Of note, this patient group is one of the high-risk groups for postoperative nausea and vomiting, with an incidence in obstetrics and gynaecology of 40-80%. Cannabidiol oil is typically well tolerated with a favourable side effect profile as it non psychoactive. Previous studies have documented that the most common side effects observed were somnolence, sedation and altered mood.

Recruitment of patients will be done on the ward on the day prior to surgery. Time will be allowed for questioning and gathering of information and all risks will be explained. Written consent will be obtained by the researcher, or the research assistant, who will not be involved in the intra-operative management of the patient. The preoperative assessment will be conducted by the anaesthetist as per usual.

The study will be a single centre, double-blinded (patient and attending Anaesthetist) randomised controlled trial. Patients will be randomly allocated into one of two groups:

  • Group 1 - Intervention group
  • Group 2 - Placebo group

A sample size of 120 patients was calculated, 60 per group, based on an alpha value of 0.05, beta value of 0.2 and an expected proportion of 50%. An increase by 10% was done to address anticipated drop outs. The Intervention group will receive 5.5mg (10 drops) of Cannabidiol oil (infused peppermint oil) sublingually. The placebo group will receive 10 drops of peppermint oil or similar taste.

The intervention (Cannabidiol oil) and placebo will be placed in identical amber, 2ml glass bottles, each having a different assigned number-letter code. The assigned codes will be computer generated and the bottles will be labelled by the pharmacist. The participants will be randomised using an online randomiser programme (www.randomization.com). The pharmacist will assign an appropriate code to the patient/s based on the randomisation table on the day prior to surgery, which will be given to the researcher.

Two to three hours prior to surgery, the assigned agent will be administered by the researcher or assistant. The person administering the intervention will not participate in the conduct of anaesthesia or the collection of data. A protocol is in place to monitor and manage any untoward adverse drug reactions, including anaphylaxis. A standardized technique of General Anaesthesia will be implemented:

  • Induction with propofol at 2mg/kg
  • Muscle relaxation with Cisatracurium 0.1mg/kg
  • Morphine 0.1mg/kg
  • Panadol 1g

Data will be collected on medications administered, length of anaesthesia and estimated blood loss. For antiemetic prophylaxis, a standardised protocol of dexamethasone 8mg and dimenhydrinate 0.5mg/kg (~50mg) will be given. In the postoperative period, the rescue protocol in the event of an episode of vomiting or severe nausea is as follows:

  1. Step 1: Repeat dose of dexamethasone 4mg
  2. Step 2 if no resolution: Kytril 1mg

The proposed study will also include an assessment of the risk of post operative nausea and vomiting, assessment of the presence and severity of any nausea and vomiting and an assessment of patient satisfaction with their overall anaesthesia experience. The Apfel score will be used to assess the risk of postoperative nausea and vomiting, and includes four factors: sex, smoking history, previous history of nausea and vomiting or motion sickness and any plan to use postoperative opioids by the medical team. This produces a score between I and IV and the risk of postoperative nausea and vomiting increases with an increasing score. An Apfel score of I usually carries a 20% risk of postoperative nausea and vomiting and this increases to 80% with a score of IV. The purpose of determining the Apfel score at the time of written consent is to evaluate the effect of the Cannabidiol intervention on not only the overall incidence of postoperative nausea and vomiting, but also to be able to determine how it affects different risk groups. The BARF scale will be used to assess the presence of nausea, which is a subjective sensation and challenging to capture.It consists of six faces, with a scale from 0 to 10. The BARF scale will be checked on arrival to and on discharge from the Post Anaesthetic Care Unit. The Leiden Peri-operative care Patient Satisfaction questionnaire (LPPSq) will be used to assess patient satisfaction and will be conducted 24 to 48 hours postoperatively. It assesses satisfaction with respect to information received, any fears and concerns, professional competence, service and staff-patient relationships.

The data will be collected by the anaesthesia and recovery room nursing staff from the intra-operative anaesthetic and recovery room records. The researcher will then collect all sheets and conduct the patient satisfaction questionnaire between 24 and 48 hours postoperatively. The Apfel score will be assessed by the anaesthetist in charge of the patient at the preoperative visit. The BARF scale will be done by the recovery room and ward nursing staff.

Data will be entered into and analysed using SPSS v. 26.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

All patients for elective gynaecological surgical procedures under general anaesthesia at the Main operating theatre, UHWI between the ages of 18-65 years.

Exclusion Criteria:

  • Reported allergy to cannabis/CBD by products, coconut oil, peppermint oil
  • Patients < 18 years
  • Patients experiencing disease related nausea and vomiting
  • Patients with psychological/psychiatric illnesses which prevent communication or impairs their ability to give informed consent
  • Patients undergoing regional anaesthesia
  • Contraindication to medicinal cannabis such as unstable cardiovascular disease, substance use disorder, or significant mental health disorder
  • Cannabis use within 30 days of surgery
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cannabidiol Oil
Cannabidiol oil 5.5mg, equivalent to 10 drops
Drug: Cannabidiol Oil
Cannabidiol oil will be administered sublingually 2-3 hours preoperatively
Other Names:
  • CBD
Placebo Comparator: Placebo
Peppermint oil, 10 drops
Drug: Placebo
Placebo will be administered sublingually 2-3 hours preoperatively
Other Names:
  • PLA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Operative Vomiting
Time Frame: 24 hours post surgery
All episodes of vomiting will be recorded by the nursing staff in the Post anaesthesia care unit and after discharge, by the ward nurses for the first 24 hours after surgery.
24 hours post surgery
Postoperative Nausea
Time Frame: 24 hours post surgery
The BARF score will be administered by the nursing staff in the Post anaesthesia care unit to assess nausea on admission and on discharge from the unit. It will also be assessed by the ward nurses at 4 hour intervals during vital checks for the first 24 hours after surgery.
24 hours post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total analgesic requirements
Time Frame: 24 hours post surgery
All analgesics administered in the Post Anaesthesia Care unit and on the ward up to 24 hours post procedure will be documented.
24 hours post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of The West Indies

Investigators

  • Principal Investigator: Ingrid Tennant, DM, PhD, University Hospital of the West Indies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2023

Primary Completion (Estimated)

January 31, 2024

Study Completion (Estimated)

February 29, 2024

Study Registration Dates

First Submitted

May 3, 2023

First Submitted That Met QC Criteria

November 16, 2023

First Posted (Estimated)

November 17, 2023

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREC-MN.0722/2022/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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