Comparison of blood sugar fluctuations in diabetic patients undergoing coronary artery bypass grafting; General anesthesia versus general anesthesia along with spinal anesthesia
This study is a prospective and randomized double-blind clinical trial. The aim of this study is comparison of blood sugar fluctuations in diabetic patients undergoing coronary artery bypass grafting; general anesthesia versus general anesthesia along with spinal anesthesia. Total of sample size is 24 patient with ages: 50-65 years old. Inclusion criteria are diabetic patients candidate for coronary artery bypass surgery. The patients with heart block, cardiomegaly, kidney failure and hypothyroidism will be excluded. Patients are randomly divided into two groups with table of random numbers. Assessor of study and patients do not know about grouping people. Anesthesia induction in two groups is with 0.01 mg/kg midazolam, 3 mcg/kg fentanyl, 3 mg thiopental sodium and 0. 6 mg/kg atracurium. All two groups receives 0.5 mg/kg midazolam intramuscularly, half an hour before surgery. First group will go under general anesthesia. Second group will go under general anesthesia along with spinal anesthesia. Patients basic information such as age and sex, BMI will be recorded in all two groups. Blood pressure, heart rate and blood glucose before induction, five minutes after induction and once every 15 minutes during surgery will be recorded in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017040833300N1
Registration date:2017-04-23, 1396/02/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-23, 1396/02/03
Registrant information
Name
Maryam sadat hoseini
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 2922
Email address
hoseini.ms@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor For Research Of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2017-01-01, 1395/10/12
Expected recruitment end date
2017-05-02, 1396/02/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of blood sugar fluctuations in diabetic patients undergoing coronary artery bypass grafting; General anesthesia versus general anesthesia along with spinal anesthesia
Public title
Comparison of blood sugar fluctuations in diabetic patients during heart surgery in the various methods of anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Diabetic patients candidate for coronary artery bypass surgery. Exclusion Criteria: Patients with EF less than 35; Heart block; Cardiomegaly; Kidney failure; and hypothyroidism.
Age
From 50 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University Of Medical Sciences
Street address
Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, Golestan BLvd., Ahvaz
City
Ahvaz
Postal code
Approval date
2016-12-31, 1395/10/11
Ethics committee reference number
IR.AJUMS.REC.1395.604
Health conditions studied
1
Description of health condition studied
Blood sugar changes
ICD-10 code
E16.0
ICD-10 code description
Drug-induced hypoglycaemia without coma
Primary outcomes
1
Description
Blood sugar
Timepoint
Before induction, five minutes after induction and once every 15 minutes during surgery
Method of measurement
Glucometer
Secondary outcomes
1
Description
Heart beat
Timepoint
During surgery
Method of measurement
Electrocardiogram
2
Description
Blood pressure
Timepoint
During surgery
Method of measurement
Sphygmomanometer
Intervention groups
1
Description
Control group: general anesthesia with 0.01 mg/kg midazolam, 3 mcg/kg fentanyl, 3 mg thiopental sodium and 0. 6 mg/kg atracurium.
Category
Treatment - Drugs
2
Description
Intervention group: Spinal anesthesia by intrathecal injection of 12.5 mg of marcaine 0.5 % with 50 mg of pethidine and then induction of general anesthesia (such as control group).
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Amir Salari
Street address
Khomeini Hospital, ShahidAhwazian St., Ahwaz
City
Ahvaz
2
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Farhad Soltani
Street address
Golestan Hospital, Farvardin st., Golestan, Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor For Research Of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nader Saki
Street address
Vice chancellor For Research Of Ahvaz Jondishapour University of Medical Sciences, Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor For Research Of Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Maryam Sadat Hoseini
Position
Resident of anesthesiology
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3222 2922
Fax
Email
Maryamsadat1815@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Kamalodin Tabatabaie
Position
anesthesiologist
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3222 2922
Fax
Email
dr_tabatabaie1964@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Sanaz Nazari
Position
Nurse of Anesthesia
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
00
Fax
Email
s.nz1990@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)