1. Home
  2. Approved trials
  3. » فارسی

The effects of dexmedetomidine on post-operative blood glucose level in non diabetic patients undergoing cardiac surgery

Protocol summary

Study aim
The effects of dexmedetomidine on post-operative blood glucose level in non diabetic patients undergoing cardiac surgery
Design
A clinical trial with the control group, with parallel groups, double-blind, randomized, phase 3 on 72 non-diabetic patients undergoing elective coronary artery surgery. Random sequence generation site www.sealedenvelope.com is used for randomization.
Settings and conduct
72 patients in Shahid Faghihi and Abu Ali Sina hospitals are divided into two groups (each group includes 36 people), group D (dexmedetomidine) and group C (control). After induction of anesthesia, infusion of dexmedetomidine at a dose of 0.5 µ g / kg/hr in group D and in the control group (C) normal saline 0.9% with the same volume will be started and continued until the end of surgery. And we measure their blood glucose levels before, during, and after the operation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Adult non-diabetic patients 40 to 80 years with EF more than 40% who are candidates for coronary artery bypass graft (CABG) surgery with informed written consent. exclusion criteria: emergency, valvular disorders, liver and kidney disease, steroid use, history of drug allergies, heart failure, acute myocardial infarction.
Intervention groups
Intervention group 1 (dexmedetomidine (D)) Continuous injection of dexmedetomidine made by EXIR Company at a dose of 0.5 µ g / kg / hr. By continuous infusion pump after induction of anesthesia, Intervention 2 (Control (C)) injection of normal saline 0.9% with the same amount.
Main outcome variables
Blood Glucose-potassium-mean arterial pressure-Heart rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180922041084N5
Registration date: 2022-01-05, 1400/10/15
Registration timing: retrospective

Last update: 2022-01-05, 1400/10/15
Update count: 0
Registration date
2022-01-05, 1400/10/15
Registrant information
Name
Maryam Tabibzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3628 1460
Email address
dpt2370349433@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-12, 1400/06/21
Expected recruitment end date
2021-11-12, 1400/08/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of dexmedetomidine on post-operative blood glucose level in non diabetic patients undergoing cardiac surgery
Public title
The effects of dexmedetomidine on post-operative blood glucose level in non diabetic patients undergoing cardiac surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The Patients are Candidates for Coronary Artery Surgery (CABG). No history of diabetes. The patients 40 to 80 years of age Receive informed written consent EF more than 40%.
Exclusion criteria:
emergency surgery valvular heart disease liver and kidney dysfunction take steroids History of drug sensitivity heart failure Acute Myocardial Infarction
Age
From 40 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the limited randomization method of block randomization. The size of all blocks is equal and we will have 6 groups of 6 blocks (including 3 participants in the intervention group and 3 participants in the control group) in this two-group experiment. The randomization list is also taken from the random sequence generation site www.sealedenvelope.com, which is able to generate random sequences by blocking method.
Blinding (investigator's opinion)
Double blinded
Blinding description
Medications in 50cc syringes are prepared by a nurse anesthetist (who is not involved in the rest of the sample collection process) and the anesthesiologist and nurse anesthetist and ICU nurse who is responsible for monitoring and sampling the patient is not aware of the type of medication prescribed.
Placebo
Used
Assignment
Parallel
Other design features
change of blood glucose level during the surgery.The effects of dexmedetomidine on postoperative blood glucose level, measurement of potassium, blood pressure, and heart rate during surgery.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2020-05-20, 1399/02/31
Ethics committee reference number
IR.SUMS.MED.REC.1399.097

Health conditions studied

1

Description of health condition studied
Coronary Arteria Bypass Graft
ICD-10 code
Z95.1
ICD-10 code description
Presence of aortocoronary bypass graft

Primary outcomes

1

Description
Blood Glucose
Timepoint
Blood sugar before, during, and after surgery. Before induction of anesthesia, 15 minutes after induction of anesthesia, before the start of the cardiopulmonary pump, 30 minutes after the start of the cardiopulmonary pump, time of transfer to ICU 6 hours after transfer to ICU, 12 hours after transfer to ICU, and 24 hours after transfer to ICU.
Method of measurement
Check Blood glucose by glucometer.

Secondary outcomes

1

Description
Blood Potassium
Timepoint
Before induction of anesthesia (T0), 15 minutes after induction of anesthesia (T1), before the start of the cardiopulmonary pump (T2), 30 minutes after the start of the cardiopulmonary pump (T3), transfer time to ICU(T4), 6 hours after transfer to ICU (T5), 12 hours after transfer to ICU (T6), 24 hours after ICU transfer (T7).
Method of measurement
By blood gas.

2

Description
Check Heart rate
Timepoint
Before induction of anesthesia (T0), 15 minutes after induction of anesthesia (T1), before the start of the cardiopulmonary pump (T2), 30 minutes after the start of the cardiopulmonary pump (T3), transfer time to ICU(T4), 6 hours after transfer to ICU (T5), 12 hours after transfer to ICU (T6), 24 hours after ICU transfer (T7).
Method of measurement
By heart monitoring

3

Description
Mean Arterial blood pressure
Timepoint
transfer time to ICU(T4), 6 hours after transfer to ICU (T5), 12 hours after transfer to ICU (T6), 24 hours after ICU transfer (T7).
Method of measurement
Invasive arterial blood pressure monitoring.

Intervention groups

1

Description
Intervention group: Intervention group or group (dexmedetomidine (D)): In this group, continuous injection of dexmedetomidine made by ExIR Company at a dose of 0.5 µ g / kg/hr. It is infused by a continuous infusion pump after induction of anesthesia.
Category
Treatment - Drugs

2

Description
Control group: (control (C)) in this group injection of normal saline 0.9% at a dose of 0.5 µ g / kg / hr. It will be infused by a continuous infusion pump after induction of anesthesia.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Abu Ali Sina Hospital - Shahid Faghihi Hospital
Full name of responsible person
Mrs.Godarzi & Mr.parsaean
Street address
Shiraz - Sadra Town, Phase 2, Abu Ali Sina Hospital Shiraz, Zand Blvd., Shahid Faghihi Hospital
City
Shiraz
Province
Fars
Postal code
7199467985(بیمارستان
Phone
+98 71 3235 1087
Fax
+98 71 3643 0038
Email
ga568881@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Abas Rezaianzadeh
Street address
Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3234 9333
Fax
+98 71 3234 9333
Email
Vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Amirhosein Hasanzade
Position
Anesthesiology resident/physician
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3630 4312
Email
A.hsanzade1367@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Simin Azemati
Position
Cardiac Anesthesiology Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4270
Email
azemati@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
MaryamTabibzadeh
Position
Medical Doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Fax
+98 71 3628 1506
Email
drtabib.maryam@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
It is against our policy.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...