Comparision of glargine insulin and Regular insulin on quality of perioperative glucose control in type2 diabetic patient undergoing viterectomy under general anesthesia
The aim of current study is to comparison of glargine insulin and Regular insulin on quality of perioperative glucose control in type 2 diabetic patient undergoing viterectomy under general anesthesia.
Design
Clinical trial study, with parallel groups, double blinded, randomized
Settings and conduct
80 eligible patients were selected by using randomization method was performed randomly per muted blocks and based on online randomization software randomly and assigned to one of the groups receiving glargine insulin (intervention) or receiving regular insulin (control). All long-term oral and long-acting insulin medications stop the day before surgery. In the morning, the blood sample was checked for potassium and fasting blood glucose and fasting blood capillary blood flow and the patients received subcutaneous glargine insulin or subcutaneous insulin in accordance with the study group. After the start of surgery, every 30 to 45 minutes, capillary blood glucose is checked by glucometer and marked with vital signs. 2 and 4 hours after surgery, capillary blood glucose is also checked. All blood glucose, incidence of hypoglycemia, dose required for regurgitation and duration of surgery are included in the relevant doses.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 30-70 years old, Duration of diabetes more than 3 months, New York Heart Association (NYHA) Classification 1 or 2.
Exclusion criteria: Diabetic ketoacidosis or its history, Renal failure, Liver failure, Hypoglycemia episodes in a hospital, Hyperglycemia without a history of diabetes, Pregnancy, Patients or psychiatric disorders that can not provide information. Corticosteroid use, Infection and sepsis, BMI> 35
Intervention groups
Intervention group: Patients received Glargine insulin during surgery
Control group : Patients received Regular insulin during surgery
Main outcome variables
Blood Glucose.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141127020112N8
Registration date:2018-12-27, 1397/10/06
Registration timing:retrospective
Last update:2018-12-27, 1397/10/06
Update count:0
Registration date
2018-12-27, 1397/10/06
Registrant information
Name
Pooya Derakhshan
Name of organization / entity
Birjand Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3234 1410
Email address
pooya_derakhshan@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-11, 1396/05/20
Expected recruitment end date
2018-08-11, 1397/05/20
Actual recruitment start date
2017-09-03, 1396/06/12
Actual recruitment end date
2018-08-16, 1397/05/25
Trial completion date
2018-09-08, 1397/06/17
Scientific title
Comparision of glargine insulin and Regular insulin on quality of perioperative glucose control in type2 diabetic patient undergoing viterectomy under general anesthesia
Public title
Comparision of glargine insulin and Regular insulin on quality of perioperative glucose control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 30-70 years old
Duration of diabetes for more than three months
New York Heart Association (NYHA) class 1 or 2
Exclusion criteria:
Diabetic ketoacidosis or its history
Renal failure
Liver failure
Hypoglycemia episodes in a hospital
Hyperglycemia without a history of diabetes
Pregnancy
Patients or psychiatric disorders that can not provide information
Corticosteroid use
Infection and sepsis
BMI more than 35
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly assigned to intervention and control groups. The randomization method was performed randomly per muted blocks and based on online randomization software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and the person evaluating the treatment outcome will be blinded to the allocated groups.
Placebo
Not 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 Sciences
Street address
Iran University of Medical Sciences., next to Milad Tower., Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-07-15, 1396/04/24
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9411174022
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Blood Glucose
Timepoint
Every 45 minutes during surgery
Method of measurement
Glucometry
Secondary outcomes
1
Description
Blood potassium
Timepoint
2 and 4 hours after surgery
Method of measurement
Blood test
Intervention groups
1
Description
Intervention group: Patients received Glargine insulin (2/3 of the total dose of insulin) during surgery
Category
Treatment - Drugs
2
Description
Control group: Patients received Regular insulin (Unit=glucose/150) during surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Pooya Derakhshan
Street address
Hazrat-E-Rasool Hospital, Iran University of Medical Sciences, Niayesh St.,Sattarkahn Ave., Tehran,
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 5001
Email
SchoolOfMedicine@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Kazem Malakuti
Street address
Iran University of Medical Sciences., next to Milad Tower., Hemat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8163 3685
Email
PR@iums.ac.ir
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
Pooya Derakhshan
Position
Assistant professor
Latest degree
Specialist
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
1916737183
Phone
+98 21 6435 2326
Email
pooyaderak@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Pooya Derakhshan
Position
Assitant professor
Latest degree
Specialist
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
1916737183
Phone
+98 21 6435 2326
Email
pooyaderak@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Pooya Derakhshan
Position
Assitant professor
Latest degree
Specialist
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
1916737183
Phone
+98 21 6435 2326
Email
pooyaderak@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
We have not yet set a conclusion
When the data will become available and for how long
We have not yet set a conclusion
To whom data/document is available
We have not yet set a conclusion
Under which criteria data/document could be used
We have not yet set a conclusion
From where data/document is obtainable
We have not yet set a conclusion
What processes are involved for a request to access data/document