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Comparison of the effects of propofol and isoflurane on blood glucose during surgery in diabetic patients

Protocol summary

Summary
The purpose of this study was to compare the effects of propofol and isoflurane on blood glucose during abdominal hysterectomy in the diabetic women in Shahid Sadoughi hospital , Yazd, Iran. In this randomized double blind trial,30women, aged 35-65 years old, and ASA physical status II, are assigned into one of the two groups to receive propofol or isoflurane for maintenance of anesthesia. systolic ,diastolic and mean arterial pressure ,end tidal co2 are measured before induction of anesthesia ,immediately after intubation ,after skin incision , and then every 15 minutes until the end of surgery.Bloob glucose is measured before induction of anesthesia ,after skin incision and every30 minutes until the end of recovery time .Dextrose -saline half normal and regular insulin infuse during surgery to control blood glucose between 100-180 mg/dl.Total dose of insulin that is used during surgery is recorded .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201203032963N5
Registration date: 2012-03-18, 1390/12/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-03-18, 1390/12/28
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
2012-02-20, 1390/12/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of propofol and isoflurane on blood glucose during surgery in diabetic patients
Public title
Comparison of the effects of two anesthetic drugs on blood glucose during surgery in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: type II diabetic women who are candidate for elective abdominal hysterectomy, age 35-65years old and their BS at the night before surgery and FBS were<200 ,Exclusion criteria: patients with diabetic nephropathy ,ischemic heart disease,a history of allergy to anesthetic drugs ,severe hepatic disease ,opium addiction,BMI>35
Age
From 35 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not 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
Bahonar square
City
yazd
Postal code
Approval date
2012-02-18, 1390/11/29
Ethics committee reference number
148522

Health conditions studied

1

Description of health condition studied
diabetes
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus

Primary outcomes

1

Description
blood glucose
Timepoint
before induction of anesthesia ,after skin incision and every30 minutes until the end of recovery time
Method of measurement
Glucometer (Accu-chek)and blood sample

2

Description
insulin requirements
Timepoint
at the end of surgery
Method of measurement
the units of required insulin

Secondary outcomes

1

Description
systolc ,diastolic and mean arterial pressure
Timepoint
Before induction of anesthesia ,immediately after intubation ,and then every 15 minutes
Method of measurement
with using blood pressure monitoring device (SAADAT)

Intervention groups

1

Description
in this group maintenance of anesthesia is with 0.5-1 MAC isoflurane
Category
Treatment - Drugs

2

Description
In this group maintenance of anesthesia is with propofol 100-200 microgram/kg/min
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
City
YAZD

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Hasan Mozaffari
Street address
Bahonar square
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
Assistant of professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital Ebnesina Avenue
City
yazd
Postal code
Phone
+98 35 1822 4101
Fax
Email
DRBEHDAD@YAHOO.COM
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
Anesthesiologist
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
YAZD
Postal code
Phone
+98 35 1822 4101
Fax
Email
drbehdad@yahoo.com
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
Anesthesiologist
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
yazd
Postal code
Phone
+98 35 1822 4101
Fax
Email
drbehdad@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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