Protocol summary

Summary
Surgery and pain are associated with stress response that lead to increase in stress hormones such as norepinephrine, epinephrine, etc. These hormones may stimulate gluconeogenesis and increment in blood sugar. It seems general or spinal anesthesia may reduce the stress response due to surgery, thus we aimed to compare between the effects of these two ways on blood glucose. This study was a single blind randomized clinical trial scheduled on 60 patients with American society anesthesia physical classification system (ASA) 1 or 2. In this study blood glucose was measured before operation as a baseline glucose, intraoperative and at 2, 12, 24 hours from end of the surgery then the data in each hour from one patient subtract from preoperative data of him or herself. These differences in any times were compared between patients undergoing cesarean under general or spinal anesthesia

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015030821383N1
Registration date: 2015-07-24, 1394/05/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-07-24, 1394/05/02
Registrant information
Name
Amir Saber Tanha
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3243 2778
Email address
dr.saber@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2015-01-27, 1393/11/07
Expected recruitment end date
2015-07-29, 1394/05/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing of plasma blood sugar between patients undergoing elective cesarean section under general or spinal anesthesia
Public title
Comparing of plasma blood sugar between patients undergoing elective cesarean section under general or spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all weman with the age range between 20 to 50 who has been sheduled for elective cesarean section surgery under general or spinal anesthesia. Exclusion criteria: diabetus mellitus; history of corticosteroid therapy; recent oxytocin administration; history of addiction; history of gestational diabetus mellitus; history of preeclampsia.
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Ghafari Street
City
Birjand
Postal code
9717853577
Approval date
2015-01-26, 1393/11/06
Ethics committee reference number
93-11-02

Health conditions studied

1

Description of health condition studied
General anesthesia,spinal anesthesia
ICD-10 code
Y84.8
ICD-10 code description
Other medical procedures

Primary outcomes

1

Description
Changes in serum levels of blood sugar
Timepoint
Intraoperative, postoperative, 2 hours after surgery, 12 hours after surgery and 24 hours after surgery
Method of measurement
In milligrams per deciliter of glucometer

Secondary outcomes

1

Description
Blood pressure
Timepoint
Intraoperative, postoperative, 2 hours after surgery, 12 hours after surgery and 24 hours after surgery
Method of measurement
Manometer

Intervention groups

1

Description
general anesthesia
Category
N/A

2

Description
spinal anesthesia
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr hospital of birjand university of medical sciences
Full name of responsible person
Dr. Amir Saber Tanha, anesthesiologist/assistant proffessor
Street address
Valiasr hospital, Ghafari street, Birjand
City
Birjand

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Asghar Zarban
Street address
Birjand University of Medical Sciences, Ghafari Street
City
Birjandnd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Dr. Amir Saber Tanha
Position
Assistant professor of anesthesia
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghafari Street
City
Birjand
Postal code
9717615583
Phone
+98 56 3243 2778
Fax
Email
dr.saber@bums.ac.ir
Web page address
www.bums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Amir Saber Tanha
Position
Assistant professor of anesthesia
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghafari Street
City
Birjand
Postal code
9717614483
Phone
+98 56 3243 2778
Fax
Email
dr.saber@bums.ac.ir
Web page address
www.bums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Amir Saber Tanha
Position
Anesthesiologist, assisstant professor
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghafari Street
City
Birjand
Postal code
9717615583
Phone
+98 56 3243 2778
Fax
Email
dr.saber@bums.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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