PMID- 15336470
OWN - NLM
STAT- MEDLINE
DCOM- 20041108
LR  - 20190922
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 26
IP  - 7
DP  - 2004 Jul
TI  - Effects of granisetron in the treatment of nausea and vomiting after laparoscopic 
      cholecystectomy: a dose-ranging study.
PG  - 1055-60
AB  - BACKGROUND: Patients undergoing general anesthesia for laparoscopic 
      cholecystectomy are at high risk for postoperative emetic symptoms (nausea, 
      vomiting, and retching). Antihistamines, butyrophenones, dopamine receptor 
      antagonists, and selective serotonin receptor antagonists (SSRAs) have been 
      investigated for the prevention and treatment of emetic symptoms. However, these 
      drugs are associated with undesirable adverse effects (AEs), such as excessive 
      sedation, hypotension, dry mouth, dysphoria, hallucinations, and extrapyramidal 
      signs. Granisetron hydrochloride is a newer SSRA developed for the prevention and 
      treatment of cytotoxic drug-induced emetic symptoms, but its effects in 
      postoperative laparoscopic cholecystectomy have not been studied. OBJECTIVE: The 
      aims of this study were to assess the efficacy and tolerability of 4 doses of 
      granisetron, and to determine the minimum effective dose, for the control of 
      established emetic symptoms in patients undergoing general anesthesia for 
      laparoscopic cholecystectomy. METHODS: This prospective, randomized, 
      double-blind, placebo-controlled, dose-ranging study was conducted in the 
      Departments of Anesthesiology and Surgery, Toride Kyodo General Hospital (Toride, 
      Japan). Male and female patients aged 23 to 68 years with American Society of 
      Anesthesiologists physical status I (no organic, physiologic, biochemical, or 
      psychiatric disturbance) who were experiencing nausea lasting >10 minutes or 
      retching or vomiting within 3 hours after recovery from general anesthesia for 
      laparoscopic cholecystectomy were enrolled. Patients were randomized to receive a 
      single IV dose of placebo or granisetron at 1 of 4 doses (10, 20, 40, or 80 
      microg/kg). Patients were monitored for 24 hours after study drug administration. 
      RESULTS: One hundred patients (60 women, 40 men; mean [SD] age, 48 [10] years 
      [range, 23-68 years]; mean [SD] height, 158 [7] cm [range, 145-177 cm]; mean [SD] 
      body weight, 56 [8] kg [range, 43-75 kg]) were enrolled. No significant 
      differences in baseline demographic or clinical characteristics were found 
      between the study groups. The proportions of patients who were free of emetic 
      symptoms were significantly higher with granisetron 20, 40, and 80 microg/kg than 
      with placebo (P = 0.02, 0.007, and 0.007, respectively). The difference between 
      the granisetron 10-microg/kg group and the placebo group was not significant. No 
      clinically significant AEs were reported in any group. CONCLUSIONS: Granisetron 
      20 microg/kg was the minimum effective dose for the treatment of established 
      postoperative emetic symptoms in patients undergoing laparoscopic 
      cholecystectomy. Increasing the dose to 80 microg/kg provided no further benefit.
FAU - Fujii, Yoshitaka
AU  - Fujii Y
AD  - Department of Anesthesiology, University of Tsukuba Institute of Clinical 
      Medicine, Tsukuba, Ibaraki 305-8576, Japan. yfujii@md.tsukuba.ac.jp
FAU - Tanaka, Hiroyoshi
AU  - Tanaka H
FAU - Kawasaki, Tsuneo
AU  - Kawasaki T
LA  - eng
PT  - Clinical Trial
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  - WZG3J2MCOL (Granisetron)
SB  - IM
RIN - Clin Ther. 2018 Apr 30;:. PMID: 29724497
MH  - Adult
MH  - Aged
MH  - Antiemetics/administration & dosage/adverse effects/*therapeutic use
MH  - Cholecystectomy
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Granisetron/administration & dosage/adverse effects/*therapeutic use
MH  - Humans
MH  - Laparoscopy
MH  - Male
MH  - Middle Aged
MH  - Postoperative Nausea and Vomiting/*drug therapy
MH  - Treatment Outcome
EDAT- 2004/09/01 05:00
MHDA- 2004/11/09 09:00
CRDT- 2004/09/01 05:00
PHST- 2004/05/17 00:00 [accepted]
PHST- 2004/09/01 05:00 [pubmed]
PHST- 2004/11/09 09:00 [medline]
PHST- 2004/09/01 05:00 [entrez]
AID - S0149291804901774 [pii]
AID - 10.1016/s0149-2918(04)90177-4 [doi]
PST - ppublish
SO  - Clin Ther. 2004 Jul;26(7):1055-60. doi: 10.1016/s0149-2918(04)90177-4.