Postoperative Nausea and Vomiting Clinical Trial
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)
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | February 29, 2024 |
Est. primary completion date | January 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Jamaica | University Hospital of the West Indies | Kingston |
Lead Sponsor | Collaborator |
---|---|
The University of The West Indies |
Jamaica,
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* Note: There are 24 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post Operative Vomiting | 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 | |
Primary | Postoperative Nausea | 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 | Total analgesic requirements | 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 |
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