Cannabidiol Oil Extract for Prevention of Postoperative Nausea and Vomiting

Sponsor

The University of The West Indies (Other)

Overall Status

Recruiting

CT.gov ID

NCT06137027

Collaborator

(none)

120

Enrollment

Location

Arms

5.3

Anticipated Duration (Months)

22.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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:

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.
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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Nausea and Vomiting	Drug: Cannabidiol Oil Drug: Placebo	Early Phase 1

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:

Step 1: Repeat dose of dexamethasone 4mg
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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The intervention group will receive Cannabidiol oil 5.5mg sublingually (10 drops). The control group will receive a peppermint based oil sublingually (10 drops).The intervention group will receive Cannabidiol oil 5.5mg sublingually (10 drops). The control group will receive a peppermint based oil sublingually (10 drops).

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

The patient, researcher administering the agent and the attending anaesthetist will all be blinded to the agent administered. Only the pharmacist preparing the oil will know what it contains. Patients will be allocated into one of two groups: Group 1 - Intervention group Group 2 - Placebo group

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 21, 2023

Anticipated Primary Completion Date :

Jan 31, 2024

Anticipated Study Completion Date :

Feb 29, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Post Operative Vomiting [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.
Postoperative Nausea [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.

Secondary Outcome Measures

Total analgesic requirements [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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