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The effect of ondansetron and metoclopramide on postoperative nausea and vomiting (PONV) in laparoscopic cholecystectomy.
Acronym :
IRCT registration number : Irct registration number : IRCT201111094093N3
Date registered : November 15, 2011
Registration timing : Registration while recruiting
   
Recruitment status : Recruitment complete
Expected recruitment start date : 2011-09-23
Expected recruitment end date : 2012-03-19
   
Scientific title : The effect of ondansetron and metoclopramide on postoperative nausea and vomiting (PONV) in laparoscopic cholecystectomy.
Summary :

This study compares the effects of metoclopramide and ondansetron in reducing nausea and vomiting after laparoscopic cholecystectomy. In this double blind clinical trial, 90 patients who have undergone laparoscopic cholecystectomy with general anesthesia are randomly assigned into three groups of 30 persons each and are equally placed under total intravenous general anesthesia. Before anesthesia, the patients in the intervention group will receive metoclopramide, 10 mg intravenous or ondansetron 4 mg intravenous and in the control group will receive normal saline 2cc intravenous. Postoperative nausea and vomiting were evaluated in the recovery room and 6 and 24 hours after surgery.

   
Public title : The effect of ondansetron and metoclopramide on postoperative nausea and vomiting (PONV) in laparoscopic cholecystectomy
Purpose : Prevention
Inclusion/exclusion criteria : Inclusion criteria: Candidate for laparoscopic cholecistectomy, ASA class I-II, age 15-80 years Exclusion criteria: Gastroesophageal reflux - Severe obesity - difficult airway
Minimum age : Year: 15         
Maximum age : Year: 80         
Gender : Both male and female
   
Health condition table is empty1 : Nausea and vomiting after laparoscopic cholecystectomy
Condition studied : K91.0
Condition ICD-10 code : Vomiting following gastrointestinal surgery
   
Intervention/Control1 Metoclopramide (10 mg, increased volume to 2 ml) before induction of anesthesia
Intervention category Prevention
Intervention/Control2 Ondansetron(4mg, increased volume to 2 ml) before induction of anesthesia
Intervention category Prevention
Intervention/Control3 Normal Saline, 2 ml, before induction of anesthesia
Intervention category Prevention
   
Primary outcome measure1: Nausea after surgery
Primary outcome time point In the recovery room after surgery-6 and 24 hours after surgery
Primary outcome method of measurement Observation and history taking of patients, relatives and nursing staff
Primary outcome measure2: Vomiting after surgery
Primary outcome time point In the recovery room after surgery-6 and 24 hours after surgery
Primary outcome method of measurement Observation and history taking of patients, relatives and nursing staff
   
Trial phase : N/A
Target sample size : 90
Randomization : randomized
Blinding : Double blind
Placebo : used
Assignment : Parallel
Other design features :
   
Centre name 1 Imam Khomeini Hospital
Contact person's name Masood Entezariasl
Country Iran, Islamic Republic Of
Contact details : Ardabil
Ardabil





   
Ethics committee name 1 Ardabil University of Medical Sciences
Date approved 2011-09-08
Reference number 3/902
Contact details : Daneshgah street, Ardabil
Ardabil
Ardabil
Iran, Islamic Republic Of
   
Sponsor 1 Ardabil University of Medical Sciences
Contact person's name Dr Akbar Pirzadeh
Contact details : School of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran
Ardabil
Ardabil
Iran, Islamic Republic Of

00984515512006


a.pirzadeh@arums.ac.ir
http: //medicine.arums.ac.ir
   
Person responsible for general inquiries
Masood Entezariasl
Affiliated Organization name Ardabil University of Medical Sciences
Position/degree Associate Professor of Anesthesiology
Contact details : Imam Khomeini Hospital, Ardabil, Iran
Ardabil
Ardabil
Iran, Islamic Republic Of
00984512251688
00989141512916
m.entezari@arums.ac.ir
   
Person responsible for scientific inquiries
Masood Entezariasl
Affiliated Organization name Ardabil University of Medical Sciences
Position / degree Associate Professor of Anesthesiology
Contact details : Imam Khomeini Hospital, Ardabil, Iran
Ardabil
Ardabil
Iran, Islamic Republic Of
00984512251688
00989141512916
m.entezari@arums.ac.ir
   
Person responsible for updating data
Masood Entezariasl
Affiliated Organization name Ardabil University of Medical Sciences
Position / degree Associate Professor of Anesthesiology
Contact details : Imam Khomeini Hospital, Ardabil, Iran
Ardabil
Ardabil
Iran, Islamic Republic Of
   
Registered by : Masood  Entezariasl
Ardabil University of Medical Sciences
Ardabil, Iran
Ardabil
Ardabil
Iran, Islamic Republic Of
Phone: 00984512251688
Fax: 00984512251699
m.entezari@arums.ac.ir