The purpose of this randomized, double-blind clinical trial without placebo is to compare the effect of ondanstron and dexametasone on nausea and vomiting after laparascopic cystectomy. In this study, 150 patients undergoing laparoscopic cholecystectomy operation between 65-20 years of age who meet the study inclusion and exclusion criteria are randomly assigned in one of the three intervention groups to receive ondansetron or dexamethasone, or combination of them immediately before they receive general anesthesia and the presence or absence of nausea and vomiting in the three groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105056392N1
Registration date:2011-06-11, 1390/03/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-06-11, 1390/03/21
Registrant information
Name
Hamid Reza Vafaei
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0026
Email address
vafaee_h@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2011-08-23, 1390/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of ondanstron and dexametasone on post operative nausea and vomiting in paients undergoing laparascopic cholecystectomy
Public title
Effect of ondanstron and dexametasone on post operative nausea and vomiting in paients undergoing laparascopic cholecystectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age between 20-65 years old, referring for elective laparascopic cholecystectomy
Excluding criteria: Having nausea and/ or vomiting, taking any antiemetic medication within 48 hrs before surgery, having taken H2 blockers, having a history of motion sickness, pregnancy, menstruation, renal disease with high BUN and Cr, receiving any investigational drug within 30 days prior to the surgery, requiring open approach during Laparoscopic approach
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics in Medical Research of Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences
City
Kashan
Postal code
Approval date
2011-04-27, 1390/02/07
Ethics committee reference number
29/5/1/476 /پ
Health conditions studied
1
Description of health condition studied
nausea and vomiting
ICD-10 code
K91.0
ICD-10 code description
Vomiting following gastrointestinal surgery
Primary outcomes
1
Description
nausea and vomiting
Timepoint
6 hours and 24 hours after intervention
Method of measurement
Questionnaires and observation
Secondary outcomes
1
Description
Duration of anesthesia
Timepoint
Operation from start to end
Method of measurement
Per minute
Intervention groups
1
Description
Ondansetron, 4mg, intravenously, immediately before receiving general anesthesia
Category
Treatment - Drugs
2
Description
dexamethasone, 8mg, intravenously, immediately before receiving general anesthesia
Category
Treatment - Drugs
3
Description
Combination of Ondansetron, 4mg, as well as Dexamethasone, intravenously, immediately before receiving general anesthesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan Shahid Beheshti Hospital
Full name of responsible person
Dr. Hamid Reza Vafaei
Street address
Unit 404- Complex Physicians- Amryh Square- Kashan
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholamali Hamidi
Street address
Research- Kashan University of Medical Sciences-5 km polar Ravandi Blvd
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamid Reza Vafaei
Position
General Surgery Resident
Other areas of specialty/work
Street address
Unit 404- Complex Physicians- Amryh Square- Kashan
City
Kashan
Postal code
Phone
+98 36 1534 3421
Fax
Email
vafaee_h@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Mohamad Eidy
Position
Board of General Surgery
Other areas of specialty/work
Street address
Residential Site Kashan Medical University
City
Kashan
Postal code
Phone
+98 36 1555 0026
Fax
Email
m_eidy1356@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Mohamad Eidy
Position
General Surgeon
Other areas of specialty/work
Street address
Residential Site of Kashan University of Medical Sciences
City
Kashan
Postal code
Phone
+98 36 1555 0026
Fax
Email
m_eidy1356@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)