Sublingual Cannabidiol Oil Extract for Prevention of Postoperative Nausea and Vomiting in Elective Gynaecological Patients at the University Hospital of the West Indies (UHWI)
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Postoperative Nausea
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All patients for elective gynaecological surgical procedures under general anaesthesia at the Main operating theatre, UHWI between the ages of 18-65 years.
排除标准
- •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
研究组 & 干预措施
Cannabidiol Oil
Cannabidiol oil 5.5mg, equivalent to 10 drops
干预措施: Cannabidiol Oil (Drug)
Placebo
Peppermint oil, 10 drops
干预措施: Placebo (Drug)
结局指标
主要结局
Postoperative Nausea
时间窗: 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.
Post Operative Vomiting
时间窗: 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.
次要结局
- Total analgesic requirements(24 hours post surgery)