This study compares the effects of dexamethasone 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 dexamethasone, 8 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.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110194093N2
Registration date:2011-11-15, 1390/08/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-11-15, 1390/08/24
Registrant information
Name
Masood Entezariasl
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 1225 1688
Email address
m.entezari@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University of Medical Sciences
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-06-19, 1391/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ondansetron and dexamethasone on reduction of post operative nausea and vomiting (PONV) in laparoscopic cholecystectomy
Public title
The effect of ondansetron and dexamethasone on reduction of post operative nausea and vomiting (PONV) in laparoscopic cholecystectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Candidate for laparoscopic cholecystectomy, ASA class I-II, age 15-80 years
Exclusion criteria: Gastroesophageal reflux - Severe obesity - difficult airway
Age
From 15 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardabil University of Medical Sciences
Street address
Daneshgah street, Ardabil
City
Ardabil
Postal code
Approval date
2011-09-08, 1390/06/17
Ethics committee reference number
4/902
Health conditions studied
1
Description of health condition studied
Nausea and vomiting after laparoscopic cholecystectomy
ICD-10 code
K91.0
ICD-10 code description
Vomiting following gastrointestinal surgery
Primary outcomes
1
Description
Nausea after surgery
Timepoint
In the recovery room after surgery-6 and 24 hours after surgery
Method of measurement
Observation and history taking of patients, relatives and nursing staff
2
Description
Vomiting after surgery
Timepoint
In the recovery room after surgery-6 and 24 hours after surgery
Method of measurement
Observation and history taking of patients, relatives and nursing staff
Secondary outcomes
empty
Intervention groups
1
Description
Dexamethasone (8 mg, increased volume to 2 ml) before induction of anesthesia
Category
Prevention
2
Description
Ondansetron(4mg, increased volume to 2 ml) before induction of anesthesia
Category
Prevention
3
Description
Normal Saline, 2 ml, before induction of anesthesia
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Masood Entezariasl
Street address
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Akbar Pirzadeh
Street address
School of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?