In this study, 102 cases aged between 18-65 years old who are candidate for laparoscopic cholecystectomy (LC) will be randomly assigned to receive granisetron (3mg) or dexamethasone (8mg) 15 minutes before induction of anesthesia. Method of induction is the same in both groups. It consists of general anesthesia with thiopental (5mg/kg), atracorium (0.6mg/kg), and sulfantanil (5mg) with isofluran, O2, and N2O as maintenance. After the operation, the rate of nausea and vomiting is measured every 6 hours for 24 hours and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903033939N1
Registration date:2010-05-24, 1389/03/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-05-24, 1389/03/03
Registrant information
Name
Seyed Mohammad Ali Hessami
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1727 4045
Email address
mahessami@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of dexamethasone and granisetron in the prevention of nausea and vomiting after laparoscopic cholecystectomy
Public title
Comparison of the effects of dexamethasone and granisetron in the prevention of nausea and vomiting after laparoscopic cholecystectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age between 18-65 years, candidate for laparoscopic cholecystectomy due to symptomatic gall stone,
Exclusion criteria: pregnancy, body mass index more than 30, comorbidity, previous laparatomy, gall bladder empyma, receiving opium or corticosteroid a week prior to operation
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
No. 2, Sepah square, Kermanshah
City
Kermanshah
Postal code
Approval date
2010-04-20, 1389/01/31
Ethics committee reference number
6069/420/7/پ
Health conditions studied
1
Description of health condition studied
Nausea and vomiting
ICD-10 code
k91.0
ICD-10 code description
nausea and vomiting following gasterointestinal surgery
Primary outcomes
1
Description
Rate of nausea and vomiting
Timepoint
each 6 hours for 3 times
Method of measurement
Asking from the patient
Secondary outcomes
1
Description
other complications (vertigo, headache, pruritus and sweating)
Timepoint
each 6 hours for 3 times
Method of measurement
Asking from the patient
Intervention groups
1
Description
Dexamethasone 8mg a single dose 15 minutes before anesthesia induction
Category
Treatment - Drugs
2
Description
Granisetron 3mg a single dose 15 minutes before anesthesia induction
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Shahram Moradi
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
No. 2, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Seyed Mohammad Ali Hessami
Position
Thoracic surgeon
Other areas of specialty/work
Street address
EmamReza hospital,general surgery group
City
Kermanshah
Postal code
Phone
+98 83 1427 6314
Fax
Email
mahessami@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Seyed Mohammad Ali Hessami
Position
Thoracic surgeon
Other areas of specialty/work
Street address
General surgery group, Emam Reza hospital
City
Kermanshah
Postal code
Phone
+98 83 1427 6314
Fax
Email
mahessami@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Seyed Mohammad Ali Hessami
Position
Thoracic surgeon
Other areas of specialty/work
Street address
General surgey group, Emam Reza hospital
City
Kermanshah
Postal code
Phone
+98 83 1427 6314
Fax
Email
mahessami@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)