Efficacy of preoperative dexamethasone for postoperative nausea and vomiting after laparoscopic cholecystectomy: a large-scale, multicenter, randomized, double-blind, placebo-controlled trial in Japan.
BACKGROUND
To assess the efficacy of preoperative dexamethasone for postoperative nausea and vomiting (PONV) after laparoscopic cholecystectomy (LC) in Japan.


METHODS
A total of 270 patients at eight hospitals were randomized to receive dexamethasone 8 mg (n = 136) or placebo (n = 134) intravenously before LC. The primary endpoint was the degree of PONV and antiemetic requirements within 24 h after LC. Secondary endpoints were postoperative complications, postoperative hospital stay, and cost of hospital stay. This study was registered: UMIN-CTR (UMIN000003841).


RESULTS
Within 6 h after LC, 17% (23/136) of patients in the dexamethasone group versus 24% (32/134) in the placebo group reported nausea (P = 0.3), and 5% (7/136) versus 7% (10/134) reported vomiting (P = 0.2). Metoclopramide 10 mg was used 0.09 ± 0.31 versus 0.14 ± 0.35 times (P = 0.2). From 6 to 24 h, 10% (14/136) versus 13% (17/134) reported nausea (P = 0.5), and 5% (7/136) versus 5% (7/134) reported vomiting (P = 0.8). Metoclopramide was used 0.04 ± 0.19 versus 0.03 ± 0.17 times (P = 0.8). Postoperative complications and postoperative hospital stay did not differ significantly between the two groups, but the cost of hospital stay was slightly higher in the dexamethasone group (P < 0.05).


CONCLUSIONS
Routine use of preoperative dexamethasone for PONV after elective LC in Japan was not shown to have a clinical advantage.
Department of Surgery, Osaka Police Hospital, Osaka, Japan.
Masaki
M
Wakasugi
Department of Surgery, Osaka Police Hospital, Osaka, Japan.
Masayuki
M
Tori
Department of Surgery, Osaka Rosai Hospital, Sakai, Japan.
Junzo
J
Shimizu
Department of Surgery, Kaizuka City Hospital, Kaizuka, Japan.
Yong Kook
YK
Kim
Department of Surgery, Toyonaka Municipal Hospital, Toyonaka, Japan.
Takehiro
T
Noda
Department of Surgery, Toyonaka Municipal Hospital, Toyonaka, Japan.
Keizo
K
Dono
Department of Surgery, Kansai Rosai Hospital, Amagasaki, Japan.
Yutaka
Y
Takeda
Department of Surgery, Sakai Municipal Hospital, Sakai, Japan.
Tameyoshi
T
Yamamoto
Department of Surgery, Minoh City Hospital, Minoh, Japan.
Satoshi
S
Oshima
Department of Surgery, Osaka Hospital, Osaka, Japan.
Yoshikazu
Y
Morimoto
Department of Surgery, Osaka National Hospital, Osaka, Japan.
Tadafumi
T
Asaoka
Department of Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan.
Hidetoshi
H
Eguchi
Department of Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan.
Hiroaki
H
Nagano
Department of Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan.
Masaki
M
Mori
Department of Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan.
Yuichiro
Y
Doki
D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000008:administration & dosage*; D017081:Cholecystectomy, Laparoscopic / Q000009:adverse effects* / Q000379:methods; D003907:Dexamethasone / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D007564:Japan; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D020250:Postoperative Nausea and Vomiting / Q000209:etiology / Q000517:prevention & control*; D011300:Preoperative Care / Q000379:methods; D012016:Reference Values; D018709:Statistics, Nonparametric; D016896:Treatment Outcome; D055815:Young Adult
D000932:Antiemetics; D003907:Dexamethasone
Dexamethasone; Laparoscopic cholecystectomy; Postoperative nausea and vomiting