Protocol summary

Summary
The purpose of this study is to investigate the effect of oral Diazepam on the blood sugar of patients who were candidates of operation in Taleghani hospital, Kermanshah. 80 patients, ASA I and II, were randomly allocated into two groups to receive Diazepam 5mg orally with 50cc water at the night before surgery and in the morning of surgery in the intervention group or no intervention in the control group. Patients with diabetes, kids under 1 year old, pregnant women, and shocked patients were excluded. Blood sugar was measured before intervention and 15 minutes after induction of anesthesia and compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138812233563N1
Registration date: 2010-05-29, 1389/03/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-05-29, 1389/03/08
Registrant information
Name
Gholamreza Mohseni
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1428 2670
Email address
ghmohseni@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2009-08-12, 1388/05/21
Expected recruitment end date
2010-02-12, 1388/11/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Oral Diazepam effects on post operative blood sugar in surgical patients
Public title
To study the oral Diazepam effects on post operative blood sugar in surgical patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: ASA I, II patients who were candidate for general surgery. Exclusion criteria: Presence of diabetes, kids under 1 year old, pregnant women, and shocked patients
Age
From 1 year old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
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
Ethic committee of kermanshah University of Medical Sciences
Street address
#2 building of medical university, shahid beheshti boulevard, kermanshah, Iran
City
Kermanshah
Postal code
4714435255
Approval date
2009-08-08, 1388/05/17
Ethics committee reference number
1/p/1.33918

Health conditions studied

1

Description of health condition studied
blood sugar
ICD-10 code
E16.2, R73
ICD-10 code description
Other disorders of glucose regulation and pancreatic internal secretion, Abnormal findings on examination of blood, without diagnosis

Primary outcomes

1

Description
blood sugar level
Timepoint
before anesthesia induction and 15min after induction
Method of measurement
taking blood sample and doing lab analysis

Secondary outcomes

1

Description
time of patient's full recovery
Timepoint
at the end of operation
Method of measurement
direct examination by anesthesiologist and interviewing with patients

Intervention groups

1

Description
Diazepam (Watson laboratories, Inc), 5mg orally, with 50cc water
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Dr. Gholamreza Mohseni
Street address
Imam Reza Hospital, Parastar boulevard, Sorkhalijeh, Kermanshah
City
kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Mohseni
Street address
Imam Reza Hospital, Parastar boulevard, Sorkhalijeh, Kermanshah
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 medical university
Full name of responsible person
Dr. Gholamreza Mohseni
Position
anesthesiologist and assistant professor
Other areas of specialty/work
Street address
Imam Reza Hospital, parastar boulevard, sorkhalijeh, kermanshah
City
kermanshah
Postal code
Phone
+98 83 1428 2670
Fax
Email
ghmohseni@kums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
kermanshah medical university
Full name of responsible person
Dr. Gholamreza Mohseni
Position
anesthesiologist and assistant professor
Other areas of specialty/work
Street address
Imam Reza Hospital, parastar boulevard, sorkhalijeh, kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1428 2670
Fax
Email
ghmohseni@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
Dr. Gholamreza Mohseni
Position
anesthesiologist and assistant professor
Other areas of specialty/work
Street address
Imam Reza Hospital, Parastar boulevard, Sorkhalijeh, kermanshah
City
Kermanshah
Postal code
4733315444
Phone
+98 83 1428 2670
Fax
+98 83 1428 2670
Email
ghmohseni@kums.ac.ir
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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