PMID- 20974320
OWN - NLM
STAT- MEDLINE
DCOM- 20110207
LR  - 20220318
IS  - 1879-114X (Electronic)
IS  - 0149-2918 (Linking)
VI  - 32
IP  - 9
DP  - 2010 Aug
TI  - A prospective, randomized, double-blind, placebo-controlled study to assess the 
      antiemetic effects of midazolam on postoperative nausea and vomiting in women 
      undergoing laparoscopic gynecologic surgery.
PG  - 1633-7
LID - 10.1016/j.clinthera.2010.08.005 [doi]
AB  - BACKGROUND: Postoperative nausea and vomiting (PONV) are distressing and frequent 
      adverse effects (AEs) in women undergoing laparoscopic gynecologic surgery. 
      Midazolam has been reported to be effective for preventing PONV in adults 
      undergoing middle ear surgery and children undergoing strabismus surgery or 
      tonsillectomy. OBJECTIVE: The aim of this study was to assess the antiemetic 
      effects of midazolam on PONV in women undergoing laparoscopic gynecologic 
      surgery. METHODS: This prospective, randomized, double-blind, placebo-controlled 
      study was conducted (January-December 2009) at the Department of Anesthesiology, 
      Ushiku Aiwa General Hospital (Ibaraki, Japan). Nonpregnant Japanese women (aged 
      22-54 years) undergoing myomectomy, hysterectomy, salpingo-oophorectomy, or 
      oophorectomy were randomized to receive 1 of 2 different midazolam doses (50 or 
      75 mug/kg IV) or placebo immediately after induction of anesthesia. Anesthesia was 
      induced with propofol 2 mg/kg IV, and vecuronium 0.1 mg/kg IV was used to 
      facilitate tracheal intubation. After tracheal intubation, anesthesia was 
      maintained with sevoflurane 1.0% to 3.0% (inspired concentration) and air in 
      oxygen. All episodes of PONV during the first 24 hours after anesthesia were 
      assessed by an investigator 24 hours postoperatively; the investigator was 
      blinded as to which treatment each patient had received. The patients were asked 
      if nausea, vomiting, or retching had occurred. Details were recorded of any other 
      AEs, as well as any spontaneous complaints. RESULTS: A total of 90 nonpregnant 
      Japanese women were enrolled (mean [SD] age, 35 [6] years; mean height, 159 [6] 
      cm; mean weight, 53 [8] kg). Each study group comprised 30 patients and was 
      comparable with regard to patient demographic characteristics and types of 
      surgery. The rate of patients experiencing PONV during the first 24 hours after 
      anesthesia with midazolam 50 mug/kg was 30% (P = 0.004 vs placebo) compared with 
      27% with midazolam 75 mug/kg (P = 0.002 vs placebo) and 67% with placebo. The 
      difference in the incidence of PONV between patients receiving midazolam 75 mug/kg 
      and those receiving midazolam 50 mug/kg was not statistically significant. No 
      clinically important AEs due to the study drug were observed in any of the 
      groups. CONCLUSION: Midazolam 50 mug/kg was not significantly different from 
      midazolam 75 mug/kg in the incidence of PONV, and both doses were associated with 
      significantly less PONV compared with placebo during the first 24 hours after 
      anesthesia in these Japanese women undergoing laparoscopic gynecologic surgery.
CI  - Copyright (c) 2010 Excerpta Medica Inc. All rights reserved.
FAU - Fujii, Yoshitaka
AU  - Fujii Y
AD  - First Department of Anesthesiology, Toho University School of Medicine, Tokyo, 
      Japan. yfujii@med.toho-u.ac.jp
FAU - Itakura, Michiyo
AU  - Itakura M
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Retracted Publication
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Antiemetics)
RN  - 0 (Hypnotics and Sedatives)
RN  - R60L0SM5BC (Midazolam)
SB  - IM
RIN - Clin Ther. 2018 Apr 30;:. PMID: 29724497
MH  - Adult
MH  - Antiemetics/administration & dosage/adverse effects/*therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Gynecologic Surgical Procedures/adverse effects/methods
MH  - Humans
MH  - Hypnotics and Sedatives/administration & dosage/adverse effects/therapeutic use
MH  - Japan
MH  - Laparoscopy/adverse effects/*methods
MH  - Midazolam/administration & dosage/adverse effects/*therapeutic use
MH  - Middle Aged
MH  - Postoperative Nausea and Vomiting/*prevention & control
MH  - Prospective Studies
MH  - Young Adult
EDAT- 2010/10/27 06:00
MHDA- 2011/02/08 06:00
CRDT- 2010/10/27 06:00
PHST- 2010/05/18 00:00 [accepted]
PHST- 2010/10/27 06:00 [entrez]
PHST- 2010/10/27 06:00 [pubmed]
PHST- 2011/02/08 06:00 [medline]
AID - S0149-2918(10)00265-1 [pii]
AID - 10.1016/j.clinthera.2010.08.005 [doi]
PST - ppublish
SO  - Clin Ther. 2010 Aug;32(9):1633-7. doi: 10.1016/j.clinthera.2010.08.005.