Cannabidiol Oil Extract for Prevention of Postoperative Nausea and Vomiting
NCT ID: NCT06137027
Last Updated: 2023-11-18
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
EARLY_PHASE1
Total Enrollment
120 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-09-21
Study Completion Date
2024-02-29
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Postoperative Nausea and Vomiting
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
The intervention group will receive Cannabidiol oil 5.5mg sublingually (10 drops). The control group will receive a peppermint based oil sublingually (10 drops).
Primary Study Purpose
PREVENTION
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
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
Patients will be allocated into one of two groups:
Group 1 - Intervention group Group 2 - Placebo group
Study Groups
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Cannabidiol Oil
Cannabidiol oil 5.5mg, equivalent to 10 drops
Group Type
ACTIVE_COMPARATOR
Cannabidiol Oil
Intervention Type
DRUG
Cannabidiol oil will be administered sublingually 2-3 hours preoperatively
Placebo
Peppermint oil, 10 drops
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Placebo will be administered sublingually 2-3 hours preoperatively
Interventions
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Cannabidiol Oil
Cannabidiol oil will be administered sublingually 2-3 hours preoperatively
Intervention Type
DRUG
Placebo
Placebo will be administered sublingually 2-3 hours preoperatively
Intervention Type
DRUG
Other Intervention Names
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CBD
PLA
Eligibility Criteria
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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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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The University of The West Indies
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Ingrid Tennant, DM, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of the West Indies
Locations
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University Hospital of the West Indies
Kingston, , Jamaica
Site Status
RECRUITING
Countries
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Jamaica
Central Contacts
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Facility Contacts
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References
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Becker DE. Nausea, vomiting, and hiccups: a review of mechanisms and treatment. Anesth Prog. 2010 Winter;57(4):150-6; quiz 157. doi: 10.2344/0003-3006-57.4.150.
Reference Type
BACKGROUND
Bashashati M, McCallum RW. Neurochemical mechanisms and pharmacologic strategies in managing nausea and vomiting related to cyclic vomiting syndrome and other gastrointestinal disorders. Eur J Pharmacol. 2014 Jan 5;722:79-94. doi: 10.1016/j.ejphar.2013.09.075. Epub 2013 Oct 22.
Reference Type
BACKGROUND
Macario A, Weinger M, Carney S, Kim A. Which clinical anesthesia outcomes are important to avoid? The perspective of patients. Anesth Analg. 1999 Sep;89(3):652-8. doi: 10.1097/00000539-199909000-00022.
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BACKGROUND
Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.
Reference Type
BACKGROUND
Kakodkar PS. Routine use of dexamethasone for postoperative nausea and vomiting: the case for. Anaesthesia. 2013 Sep;68(9):889-91. doi: 10.1111/anae.12308. Epub 2013 Jul 15. No abstract available.
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BACKGROUND
Tien M, Gan TJ, Dhakal I, White WD, Olufolabi AJ, Fink R, Mishriky BM, Lacassie HJ, Habib AS. The effect of anti-emetic doses of dexamethasone on postoperative blood glucose levels in non-diabetic and diabetic patients: a prospective randomised controlled study. Anaesthesia. 2016 Sep;71(9):1037-43. doi: 10.1111/anae.13544.
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BACKGROUND
Roden DM. Drug-induced prolongation of the QT interval. N Engl J Med. 2004 Mar 4;350(10):1013-22. doi: 10.1056/NEJMra032426. No abstract available.
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BACKGROUND
Kothari SN, Boyd WC, Bottcher ML, Lambert PJ. Antiemetic efficacy of prophylactic dimenhydrinate (Dramamine) vs ondansetron (Zofran): a randomized, prospective trial inpatients undergoing laparoscopic cholecystectomy. Surg Endosc. 2000 Oct;14(10):926-9. doi: 10.1007/s004640080055.
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BACKGROUND
Cabral GA, Raborn ES, Griffin L, Dennis J, Marciano-Cabral F. CB2 receptors in the brain: role in central immune function. Br J Pharmacol. 2008 Jan;153(2):240-51. doi: 10.1038/sj.bjp.0707584. Epub 2007 Nov 26.
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D'Souza DC, Perry E, MacDougall L, Ammerman Y, Cooper T, Wu YT, Braley G, Gueorguieva R, Krystal JH. The psychotomimetic effects of intravenous delta-9-tetrahydrocannabinol in healthy individuals: implications for psychosis. Neuropsychopharmacology. 2004 Aug;29(8):1558-72. doi: 10.1038/sj.npp.1300496.
Reference Type
BACKGROUND
Parker LA, Rock EM, Limebeer CL. Regulation of nausea and vomiting by cannabinoids. Br J Pharmacol. 2011 Aug;163(7):1411-22. doi: 10.1111/j.1476-5381.2010.01176.x.
Reference Type
BACKGROUND
Legare CA, Raup-Konsavage WM, Vrana KE. Therapeutic Potential of Cannabis, Cannabidiol, and Cannabinoid-Based Pharmaceuticals. Pharmacology. 2022;107(3-4):131-149. doi: 10.1159/000521683. Epub 2022 Jan 28.
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BACKGROUND
Izzo AA, Borrelli F, Capasso R, Di Marzo V, Mechoulam R. Non-psychotropic plant cannabinoids: new therapeutic opportunities from an ancient herb. Trends Pharmacol Sci. 2009 Oct;30(10):515-27. doi: 10.1016/j.tips.2009.07.006. Epub 2009 Sep 2.
Reference Type
BACKGROUND
Grimison P, Mersiades A, Kirby A, Lintzeris N, Morton R, Haber P, Olver I, Walsh A, McGregor I, Cheung Y, Tognela A, Hahn C, Briscoe K, Aghmesheh M, Fox P, Abdi E, Clarke S, Della-Fiorentina S, Shannon J, Gedye C, Begbie S, Simes J, Stockler M. Oral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting: a randomised, placebo-controlled, phase II crossover trial. Ann Oncol. 2020 Nov;31(11):1553-1560. doi: 10.1016/j.annonc.2020.07.020. Epub 2020 Aug 13.
Reference Type
BACKGROUND
Hosseini A, McLachlan AJ, Lickliter JD. A phase I trial of the safety, tolerability and pharmacokinetics of cannabidiol administered as single-dose oil solution and single and multiple doses of a sublingual wafer in healthy volunteers. Br J Clin Pharmacol. 2021 Apr;87(4):2070-2077. doi: 10.1111/bcp.14617. Epub 2020 Nov 18.
Reference Type
BACKGROUND
Nitecka-Buchta A, Nowak-Wachol A, Wachol K, Walczynska-Dragon K, Olczyk P, Batoryna O, Kempa W, Baron S. Myorelaxant Effect of Transdermal Cannabidiol Application in Patients with TMD: A Randomized, Double-Blind Trial. J Clin Med. 2019 Nov 6;8(11):1886. doi: 10.3390/jcm8111886.
Reference Type
BACKGROUND
Alaia MJ, Hurley ET, Vasavada K, Markus DH, Britton B, Gonzalez-Lomas G, Rokito AS, Jazrawi LM, Kaplan K. Buccally Absorbed Cannabidiol Shows Significantly Superior Pain Control and Improved Satisfaction Immediately After Arthroscopic Rotator Cuff Repair: A Placebo-Controlled, Double-Blinded, Randomized Trial. Am J Sports Med. 2022 Sep;50(11):3056-3063. doi: 10.1177/03635465221109573. Epub 2022 Jul 29.
Reference Type
BACKGROUND
Echeverria-Villalobos M, Fiorda-Diaz J, Uribe A, Bergese SD. Postoperative Nausea and Vomiting in Female Patients Undergoing Breast and Gynecological Surgery: A Narrative Review of Risk Factors and Prophylaxis. Front Med (Lausanne). 2022 Jul 1;9:909982. doi: 10.3389/fmed.2022.909982. eCollection 2022.
Reference Type
BACKGROUND
Mahmood L, Hegde R, Mariswami M, Ollapally A. Validation of the Apfel scoring system for identification of High-risk patients for PONV. Karnataka Anaesthesia Journal. 2015;1:115.
Reference Type
BACKGROUND
White P, Shafer A, editors. Nausea and vomiting: causes and prophylaxis. Seminars in anesthesia; 1987
Reference Type
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.
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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.
Reference Type
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.
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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.
Reference Type
BACKGROUND
Other Identifiers
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CREC-MN.0722/2022/2023
Identifier Type: -
Identifier Source: org_study_id
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