The purpose of this study is comparison of effect of intravenous dexamethasone on blood sugar in patients undergoing gynecology surgery. This is a double blind single arm study. Patients with history of corticosteroid use and blood sugar>200 on surgery day morning are excluded. 60 Patients with American Society of Anesthesia (ASA) physical status I or II underwent for abdominal surgery under general anesthesia assigned into one of the two groups according to random –number table , 30 patients in dexamethasone and 30 patients in placebo group. General anesthesia induced with 2mg/kg propofol ,0.5mg/kg Atracurium and infusion of 150mg/kg/min propofol and (50% O2,50%NO2) for maintenance. In the first group dexamethasone 8mg and in the second group normal salin infused after induction of anesthesia. Blood glucose recorded in 1,2,6,12, and 24 hours after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201309192963N16
Registration date:2013-10-07, 1392/07/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-10-07, 1392/07/15
Registrant information
Name
Shekoufeh Behdad
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1822 1386
Email address
drbehdad@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2013-06-20, 1392/03/30
Expected recruitment end date
2013-09-06, 1392/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intravenous dexamethasone on blood sugar in patients undergoing gynecology surgery
Public title
Effect of intravenous dexamethasone on blood sugar in patients undergoing gynecology surgery
Purpose
Treatment
Inclusion/Exclusion criteria
include:all diabetic patients undergoing gynecology surgery
exclude: history of corticostiroid use; blood sugar>200 on surgery day morning
Age
From 25 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
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
Shahid Sadoughi University of medical sciences
Street address
Yazd. Shahid Sadoughi hospital
City
Yazd
Postal code
8915887857
Approval date
2013-09-16, 1392/06/25
Ethics committee reference number
9193
Health conditions studied
1
Description of health condition studied
Diabetes Mellitus
ICD-10 code
E10- E14
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
blood sugar
Timepoint
1,2,3,4,5,6 hours after surgery
Method of measurement
by glucometer
Secondary outcomes
empty
Intervention groups
1
Description
8 mg IV dexametasone to Intervention group
Category
Treatment - Drugs
2
Description
in the control group normal salin infused
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi hospital
Full name of responsible person
Dr Shekoufeh Behdad
Street address
Shahid Sadoughi hospital,Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of medical sciences
Full name of responsible person
Dr Hassan Mozaffari
Street address
Bahonar squ,Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi 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
Shahid Sadoughi University of medical sciences
Full name of responsible person
Dr Shekoufeh Behdad
Position
Associate professor
Other areas of specialty/work
Street address
Shahid Sadoughi hospital,Yazd
City
Yazd
Postal code
Phone
+98 35 1822 4000
Fax
Email
drbehdad@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of medical sciences
Full name of responsible person
Dr Shekoufeh Behdad
Position
Associate professor
Other areas of specialty/work
Street address
Shahid Sadoughi hospital,Yazd
City
Yazd
Postal code
Phone
+98 35 1822 4000
Fax
Email
drbehdad@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of medical sciences
Full name of responsible person
Dr Shekoufeh Behdad
Position
Associate professor
Other areas of specialty/work
Street address
Shahid Sadoughi hospital,Yazd
City
Yazd
Postal code
Phone
+98 35 1822 4000
Fax
Email
drbehdad@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)