Cannabidiol Oil Extract for Prevention of Postoperative Nausea and Vomiting
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. 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.
Timeline
- Start
- 2023-09-21
- Primary completion
- 2024-01-31
- Completion
- 2024-02-29
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cannabidiol | Other / unclassified | 5.5 mg | Other |
Indications
No indication recorded.