The purpose of this randomized placebo-controlled trial study was to evaluate the efficacy of preoperative Dexamethasone on postoperative nausea and vomiting after LC. 90 patients who were candidates of laparoscopic cholecystectomy (LC) were randomly assigned to receive Dexamethasone, 8 mg IV, or normal saline, 2cc IV, at 90 minutes before induction of anesthesia. We recorded nausea and vomiting as primary outcome every 4 hours for 16 hours.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902253931N1
Registration date:2010-06-14, 1389/03/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-06-14, 1389/03/24
Registrant information
Name
Shahla Shahrjerdi
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1222 4591
Email address
shahrjerdi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2008-03-20, 1387/01/01
Expected recruitment end date
2009-03-19, 1387/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Dexamethasone on nausea and vomiting after Cholecystectomy
Public title
Effects of Dexamethasone on nausea and vomiting after Cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Candidates of laparoscopic cholecystectomy (LC),
Exclusion criteria: Presence of diabetes, contradication for consumption of Dexamethasone, steroid drugs used 48 hours prior to the surgery
Age
No age limit
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
Shahrekord University of Medical Sciences
Street address
Ayatollah Kashani St.
City
Shahrekord
Postal code
Approval date
2010-02-20, 1388/12/01
Ethics committee reference number
1-12-88
Health conditions studied
1
Description of health condition studied
Laparascopic cholecystectomy
ICD-10 code
K80.2
ICD-10 code description
Cholecystolithiasis
Primary outcomes
1
Description
Nausea and vomiting
Timepoint
Every 4 hours till 16 hours after surgery
Method of measurement
observed and Questionnaire
Secondary outcomes
1
Description
duration of hospital stay
Timepoint
During hospitalization
Method of measurement
observed
2
Description
Medical condition
Timepoint
During the hospital stay
Method of measurement
observation
Intervention groups
1
Description
dexamethasone 8 mg IV injection 90 minutes before surgery
Category
Rehabilitation
2
Description
2cc normal saline, IV injection, 90 minutes before surgery
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Kashani Educational Therapeutic Center
Full name of responsible person
Street address
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University Of Medical Sceinces
Full name of responsible person
Dr. Mahmood Mobasheri
Street address
Research Assistant
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord University Of Medical Sceinces
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
Shahrekord University of Medical Sciences
Full name of responsible person
Dr. Mohammad Moazeni Bstgani
Position
General Surgeon
Other areas of specialty/work
Street address
Ayatollah Kashani educational Therapeutic center
City
Shahrekord
Postal code
Phone
+98 38 1222 4591
Fax
Email
dr_m_moazeni@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr. Mohammad Moazeni Bistgani
Position
General Surgeon
Other areas of specialty/work
Street address
Ayatollah Kashani Educational Therapeutic Center
City
Shahrekord
Postal code
Phone
+98 38 1222 4591
Fax
Email
dr_m_moazeni@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Dr. Mohammad Moazeni Bistgani
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
dr_m_moazeni@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)