Cannabidiol Oil Extract for Prevention of Postoperative Nausea and Vomiting

NCT06137027 | Unknown Early Phase 1 DMC

• 1 other identifier: CREC-MN.0722/2022/2023
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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:

1. 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. 2.The effect of Cannabidiol oil on patients' overall satisfaction with the anaesthetic experience.

Conditions

Postoperative Nausea and Vomiting

Keywords

Cannabidiol oil; Postoperative nausea and vomiting; Patient satisfaction

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Total analgesic requirements

  24 hours post surgery

Study Arms (2)

Cannabidiol Oil

ACTIVE COMPARATOR

Cannabidiol oil 5.5mg, equivalent to 10 drops

Drug: Cannabidiol Oil

Placebo

PLACEBO COMPARATOR

Peppermint oil, 10 drops

Drug: Placebo

Interventions

Cannabidiol Oil DRUG

Cannabidiol oil will be administered sublingually 2-3 hours preoperatively

Also known as: CBD

Cannabidiol Oil

Placebo DRUG

Placebo will be administered sublingually 2-3 hours preoperatively

Also known as: PLA

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of The West Indies: lead

Study Sites (1)

University Hospital of the West Indies

Kingston, Jamaica

RECRUITING

Related Publications (24)

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  BACKGROUND

• White P, Shafer A, editors. Nausea and vomiting: causes and prophylaxis. Seminars in anesthesia; 1987

  BACKGROUND

• Baxter AL, Watcha MF, Baxter WV, Leong T, Wyatt MM. Development and validation of a pictorial nausea rating scale for children. Pediatrics. 2011 Jun;127(6):e1542-9. doi: 10.1542/peds.2010-1410. Epub 2011 May 29.

  PMID: 21624874 BACKGROUND

• Şişman H, Aslan F, Özgen R, Alptekin D, Akil Y. Validity and Reliability Study of the Baxter Animated Retching Faces Nausea Scale. Journal of Pediatric Surgical Nursing. 2016;5:98-106.

  BACKGROUND

• Caljouw MA, van Beuzekom M, Boer F. Patient's satisfaction with perioperative care: development, validation, and application of a questionnaire. Br J Anaesth. 2008 May;100(5):637-44. doi: 10.1093/bja/aen034. Epub 2008 Mar 12.

  PMID: 18337271 BACKGROUND

• Jlala HA, Caljouw MA, Bedforth NM, Hardman JG. Patient satisfaction with perioperative care among patients having orthopedic surgery in a university hospital. Local Reg Anesth. 2010;3:49-55. doi: 10.2147/lra.s11381. Epub 2010 Jul 28.

  PMID: 22915869 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Patient Satisfaction

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Ingrid Tennant, DM, PhD

  University Hospital of the West Indies

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanessa Minott

CONTACT

876-455-2780; vanessa.minott@mymona.uwi.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: November 18, 2023
• Study Start: September 21, 2023
• Primary Completion: January 31, 2024
• Study Completion: February 29, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

JA (1)