PMID- 14749148
OWN - NLM
STAT- MEDLINE
DCOM- 20040318
LR  - 20221207
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 25
IP  - 12
DP  - 2003 Dec
TI  - Randomized, double-blind, placebo-controlled, dosed-finding study of the 
      antiemetic effects and tolerability of ramosetron in adults undergoing middle ear 
      surgery.
PG  - 3100-8
AB  - BACKGROUND: Ramosetron is a selective serotonin receptor antagonist (SSRA) that 
      is approved for the treatment of emetic symptoms induced by cytotoxic drugs in 
      Japan. We have reported that ramosetron 0.3 mg had comparable efficacy to 
      granisetron 3 mg, another SSRA, in preventing emetic symptoms in adults in the 
      first 48 hours after the start of anesthesia for middle ear surgery. Although it 
      has been shown that a high dose of ramosetron can cause adverse effects (AEs), 
      such as severe headache, the minimal effective dose of ramosetron is unknown. 
      OBJECTIVE: The aim of this study was to determine the minimum effective and 
      tolerable dose of ramosetron needed to prevent postoperative emetic symptoms in 
      adult patients undergoing middle ear surgery. METHODS: This randomized, 
      double-blind, placebo-controlled, dose-finding study was conducted at the 
      Department of Anesthesiology, Toride Kyodo General Hospital (Toride, Japan). 
      Patients aged > or =20 years scheduled for middle ear surgery were randomized to 
      receive either placebo or ramosetron at 1 of 3 doses (0.15, 0.3, or 0.6 mg), 
      regardless of body weight, i.v. immediately before anesthesia induction. Emetic 
      symptoms (nausea, retching, or vomiting) occurring from 0 to <24 and 24 to 48 
      hours after the start of anesthesia were recorded. Other AEs also were assessed. 
      RESULTS: A total of 100 patients (55 women, 45 men; mean [SD] age, 44 [12] years; 
      mean [SD] body weight, 56 [8] kg; mean [SD] height, 159 [8] cm) were enrolled. 
      Each treatment group comprised 25 patients. The treatment groups were comparable 
      with regard to demographic characteristics and type of surgery After the second 
      24 hour postanesthesia period, significantly more patients in the ramosetron 
      0.3-mg and 0.6-mg groups were emesis free than in the placebo group (both 
      P<0.001). The number of emesis-free patients in the ramosetron 0.15-mg group and 
      the placebo group were similar after both study periods. No significant 
      difference in antiemetic efficacy was found between the ramosetron 0.3-mg and 
      0.6-mg groups. No relationship between body weight and the efficacy of ramosetron 
      was observed. The incidence of AEs was similar in all 4 groups. CONCLUSIONS: 
      Ramosetron 0.3 mg, regardless of body weight, was more effective than either 
      ramosetron 0.15 mg or placebo and as effective as ramosetron 0.6 mg for the 
      prevention of emetic symptoms in the first 48 hours after the start of anesthesia 
      in this selected population of adult patients who underwent middle ear surgery.
FAU - Fujii, Yoshitaka
AU  - Fujii Y
AD  - Department of Anesthesiology, Toride Kyodo General Hospital, Toride, Japan. 
      yfujii@md.tsukuba.ac.jp
FAU - Tanaka, Hiroyoshi
AU  - Tanaka H
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  - 0 (Benzimidazoles)
RN  - 0 (Serotonin Uptake Inhibitors)
RN  - 7ZRO0SC54Y (ramosetron)
SB  - IM
RIN - Clin Ther. 2018 Apr 30;:. PMID: 29724497
MH  - Adult
MH  - Aged
MH  - Antiemetics/*therapeutic use
MH  - Benzimidazoles/adverse effects/*therapeutic use
MH  - Dizziness/etiology
MH  - Double-Blind Method
MH  - Ear, Middle/*surgery
MH  - Female
MH  - Headache/etiology
MH  - Humans
MH  - Japan
MH  - Male
MH  - Mastoid/*surgery
MH  - Middle Aged
MH  - Postoperative Nausea and Vomiting/*prevention & control
MH  - Selective Serotonin Reuptake Inhibitors/*therapeutic use
MH  - Treatment Outcome
MH  - Tympanoplasty
EDAT- 2004/01/30 05:00
MHDA- 2004/03/19 05:00
CRDT- 2004/01/30 05:00
PHST- 2004/01/30 05:00 [pubmed]
PHST- 2004/03/19 05:00 [medline]
PHST- 2004/01/30 05:00 [entrez]
AID - S0149291803900944 [pii]
AID - 10.1016/s0149-2918(03)90094-4 [doi]
PST - ppublish
SO  - Clin Ther. 2003 Dec;25(12):3100-8. doi: 10.1016/s0149-2918(03)90094-4.