Anti-Emetic Efficacy of Prophylactic Dexamethasone and Metoclopramide, and their combination in the prevention of postoperative nausea and vomiting after Laparoscopic Surgery in patients at high risk of post-operative nausea and vomiting: A Randomized, Double Blind, and Placebo-Controlled Trial
Dr. Aidah Alkaissi¹, PhD, Mohammad Dweikat², MSN, Dr. Noor Almasri³, MD
¹An-Najah National University, Faculty of medicine and Health sciences, nursing and Midwifery department Nablus, Palestine
² An-Najah National University, Faculty of Graduate Studies
³Rafeedia Hospital, Palestinian Ministry of Health
Introduction. No single antiemetic drug has proved to be a universal solution to postoperative nausea and vomiting. The aim of this study is to evaluate the effect of prophylactic dexamethasone and metoclopramide as monotherapy and in combination for female patients with moderate to high risk for PONV undergoing laparoscopic surgery under general anesthesia.
Methods. A multicenter, prospective, randomized, double-blind, placebo controlled trial. One hundred twenty female patients allocated randomly to one of the four groups, thirty patients in each. (D) group received 8 mg dexamethasone one minute immediately before induction of anesthesia and 10 ml saline before end of anesthesia. (M) group received 10 ml saline one minute immediately before induction of anesthesia and metoclopramide 20 mg before end of anesthesi. (C) group received dexamethasone (8 mg) one minute immediately before induction of anesthesia and metoclopramide (20 mg) before end of anesthesia. (P) group received 10 ml saline one minute immediately before induction of anesthesia and 10 ml normal saline before end of anesthesia. Postoperative symptoms were assessed postoperatively.
Results: There are significant differences in the incidence of vomiting in total of 24 hours postoperatively between placebo group17 (56.7%) and combination group 6 (20%), P = 0.0037, and dexamethasone group 6 (20%), P = 0.0037. The results show that the incidence of vomiting was reduced significantly by use of dexamethasone as a monotherapy or in combination with metaclopramide. The incidence of nausea reduced significantly in combination group 2(6.7) compared with placebo group 19(63.3%), P < 0.0001 and compared with metaclopramide 10(33.3%), P = 0.0106. Results show that combination group and dexamethasone are more effective to reduce incidence of nausea compared with metaclopramide and placebo. There are significant differences in the intensity of nausea 0n (0-6 Lickert Type Scale) between the combination group 1.05 (± 0.90) compared with dexamethasone 1.78 (± 1.14), P = 0.008, Metoclopramide 2.43 (± 1.03), P = 0.000 and the placebo group 3.07 (± 1.34), P=0.000. There are significant differences in the rescue antiemetic in total of 24 hour between combination group 6 (20%) compared with metoclopramide group, 13 (43.3%), P = 0.0544. and compared to the placebo group 19 (63.3%), P = 0.0008. There are significantly less incidence of pain in total of 24 hour in combination group 21(70%) compared to the placebo group 29(96.7%), P = 0.0059 and compared to metaclopramide group 28(93.3%), P = 0.0208.
Conclusion: The combination of dexamethasone plus metoclopramide is more effective prophylax in reducing the intensity of nausea than dexamethasone , metoclopramide, and placebo. Dexamethasone and the combination of dexamethasone plus metoclopramide were more eﬀective prophylaxis in preventing PONV and decrease the incidence of postoperative pain than metoclopramide alone and placebo. Patients who are at high risk for PONV should receive prophylaxis with combination therapy and found no adverse events related to use.
Keywords. PONV, Dexamethasone, Metoclopramide, Postoperative symptoms