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A comparative study on the effect of different doses of dexamethasone on blood glucose concentration in patients undergoing elective abdominal surgery

Protocol summary

Study aim
Determination of the effect of different dexamethasone doses on blood glucose concentrations in patients under elective abdominal surgery
Design
This randomized double blind clinical trial was performed on patients with elective abdominal surgery referred to Rasoul-e-Akram Hospital. The number of individuals was 96 randomly selected and randomly divided into three groups of intervention, first intervention and control.
Settings and conduct
A total of 96 patients who had undergone abdominal surgery who referred to Rasoul-e-Akram Hospital were randomly divided into three groups (two intervention and one control group). Also, the grouping of the patients and the type of drug used for the subjects involved in the study are blinded.As the patient, researcher and data analyst will be blind.( double blinded)
Participants/Inclusion and exclusion criteria
Encluding criteria: Patients undergoing abdominal surgery, aged 18-65 years. Excluding criteria: Cardiovascular, pulmonary, renal, hepatic, diabetic patients - Dissatisfaction to enter the study - Recent history of steroid use - History of allergy to any of the drugs used in the study.
Intervention groups
In a group ,4 mg intravenous dexamethasone is injected at the beginning of the surgery, and in the second group, 8 mg dexamethasone and the third group, placebo (normal saline) are injected.
Main outcome variables
After surgery, blood glucose levels were measured and recorded by the nurse at 6 hours and 24 hours after administration of dexamethasone or placebo. After recording the data, the results of the three groups are compared and analyzed statistically.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120814010599N13
Registration date: 2017-12-21, 1396/09/30
Registration timing: prospective

Last update: 2017-12-21, 1396/09/30
Update count: 0
Registration date
2017-12-21, 1396/09/30
Registrant information
Name
Poupak Rahimzadeh
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9059
Email address
p-rahimzadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the effect of different doses of dexamethasone on blood glucose concentration in patients undergoing elective abdominal surgery
Public title
Effect of dexamethasone on blood glucose concentration
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All people who are candidates for abdominal surgery
Exclusion criteria:
cardiovascular patients Recent history of steroid use History of allergy to any of the drugs used in the study. pulmonary patients renal patients hepatic patients DM patients
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who are included in the study are divided into three groups based on the randomization block using a random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient does not know which medicine he receives. The nurse is aware; the researcher like the patient does not know which patient is in what group and which method he receives. The counselor, as well as the nurse, knows which patient, which method Receives.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Science
Street address
Iran University of Medical Sciences,next to Milad Tower,Hemmat Highway,Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2015-12-09, 1394/09/18
Ethics committee reference number
ir.iums.rec.1394.8821215176

Health conditions studied

1

Description of health condition studied
Hyperglycemia due to steroid
ICD-10 code
T38.0X5A
ICD-10 code description
Adverse effect of glucocorticoids

Primary outcomes

1

Description
blood glucose levels
Timepoint
After surgery, at 6 hours and 24 hours after administration of dexamethasone or placebo.
Method of measurement
Blood glucose is measured using a glucometer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1 : . Before the intervention, blood glucose and other basic indicators are checked. 32 patients In a group ,4 mg intravenous dexamethasone is injected at the beginning of the surgery, The drugs are prepared by the operating room pharmacy in 3 ml syringes labeled as patient name. . After surgery, blood glucose levels were measured and recorded by the nurse at 6 hours and 24 hours after administration of dexamethasone or placebo.
Category
Prevention

2

Description
Intervention group 2 : . Before the intervention, blood glucose and other basic indicators are checkedand. 32 patients in the second group, 8 mg dexamethasoneare injected. The drugs are prepared by the operating room pharmacy in 3 ml syringes labeled as patient name. After surgery, blood glucose levels were measured and recorded by the nurse at 6 hours and 24 hours after administration of dexamethasone or placebo.
Category
Prevention

3

Description
Control group: Before the intervention, blood glucose and other basic indicators are checked. 64 patients in the third group, placebo (normal saline) are injected. . The drugs are prepared by the operating room pharmacy in 3 ml syringes labeled as patient name.. After surgery, blood glucose levels were measured and recorded by the nurse at 6 hours and 24 hours after administration of dexamethasone or placebo.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasool-E-Akram hospital
Full name of responsible person
Dr. Mehrdad KHodabandeh
Street address
Rasool-e-Akram hospital, Niayesh street, Satarkhan street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 8670 2503
Email
khodabandeh.mehrdad@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Javad Mosavi
Street address
ran University of Medical Sciences , next to Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
khodabandeh.mehrdad@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Poupak Rahimzadeh
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 8670 2503
Fax
+98 21 6650 9059
Email
p-rahimzadeh@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Poupak Rahimzadeh
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 8670 2503
Fax
+98 21 6650 9059
Email
p-rahimzadeh@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Poupak Rahimzadeh
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 8670 2503
Fax
+98 21 6650 9059
Email
p-rahimzadeh@tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data file of people not identifiable, protocol of doing the study,How to analyze data,informed consent from individuals, A report from a clinical study and its outcome
When the data will become available and for how long
Start the access period : 1 month after printing results
To whom data/document is available
Researchers working in academic centers
Under which criteria data/document could be used
Specific conditions for use by individuals will not be considered
From where data/document is obtainable
Contact Dr. Mehrdad Khodabandeh by email khadabandeh.mehrdad@gmail.com
What processes are involved for a request to access data/document
By sending an email and requesting the request, after a day, the information will be sent to the person
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