Metoclopramide, Versus Its Combination with Dexamethasone in the Prevention of Postoperative Nausea and Vomiting after Laparoscopic Cholecystectomy: A Double-Blind Randomized Controlled Trial Wasana Ko-iam PhD Candidate*,**, Trichak Sandhu MD**, Sahataya Paiboonworachat MD***, Paisal Pongchairerks MD****, Sunhawit Junrungsee MD**, Anon Chotirosniramit MD**, Narain Chotirosniramit MD**, Kamtone Chandacham MD**, Tidarat Jirapongcharoenlap MD**
* Clinical Epidemiology Program, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand ** Department of Surgery, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand *** Department of Anesthesiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand **** Department of Surgery, Bumrungrad International Hospital, Bangkok, Thailand
Affiliation :
Background : Postoperative nausea and vomiting (PONV) are significant problems in laparoscopic surgery.
Objective : Compare the prophylactic use of metoclopramide and its combination with dexamethasone in the prevention of
PONV in patients undergoing laparoscopic cholecystectomy (LC).
Material and Method: One hundred patients aged 18 to 75 with American Society of Anesthesiologists (ASA) class 1-2 who
candidates for elective LC at Chiang Mai University Hospital, were included in this double-blind, randomized controlled
trial (parallel design). Patients were randomly divided into two groups, by ‘Block of four’ randomization. Treatment group
received 8 mg dexamethasone and 10 mg metoclopramide, and control group received 10 mg metoclopramide and normal
saline solution 1.6 ml. These medications were administered intravenously when the gallbladder was removed from gallbladder
bed. All of investigators, anesthetists, patients, care providers, and outcome assessor were blinded. Patients were asked to
assess their nausea and vomiting at 2, 6, 12, and 24 hours postoperatively, and at discharge. The overall score of PONV
in each patient based on a four-point whole number of nausea and vomiting by verbal rating scale 0-3 (0 = no nausea and
vomiting, 1 = nausea, 2 = nausea with vomiting, and 3 = repeated vomiting ≥2 times).
Results : Fifty eligible patients were randomized to each group, and all were analyzed. There were no significant differences
between baseline characteristics of patients in the two groups. The combination of dexamethasone and metoclopramide
indicated a greater antiemetic effect with significant statistical analysis, odds ratio = 0.25 (95% confidence interval 0.11-0.55,
p = 0.001). The postoperative hospital stay in the combined group and metoclopramide group were, 1 day = 47 (94%) and
37 (74%), >1 day = 3 (6%) and 13 (26%), respectively (p = 0.012). There were no postoperative complications occurred
in both groups.
Conclusion : Intravenous administration of dexamethasone combined with metoclopramide had significant effects in
prophylaxis of nausea and vomiting after LC and shorten the hospital stay.
Clinical trials registration number: TCTR20140128001
Keywords : Dexamethasone, Metoclopramide, Postoperative nausea and vomiting (PONV), Laparoscopic cholecystectomy (LC)
