comparison the effectiveness of dexmedetomidine with midazolam on incidence of cardiac arrhythmia in off-pump coronary artery bypass surgery patients, a clinical trial.
Objective: To comparison the effectiveness of dexmedetomidine with midazolam on incidence of cardiac arrhythmia in off-pump coronary artery bypass surgery patients. Design: A single blind block randomized clinical trial. Study population: Patients will be undergoing off-pump coronary artery bypass surgery. Inclusion criteria: Patients undergoing off-pump coronary artery bypass surgery; sustaining ASA I and ASA II; aged between 18-75 years; EF more than 35%. Exclusion criteria: History of arrhythmias or heart block; EF less than 35%; history of cardiac surgery; history of valvular heart disease; having left atrial enlargement (LAE) or cardiomegaly. Sample size: 70 cases. Study intervention: Control group is receiving 0.5 mg/kg midazolam addition of 10 mcg/kg fentanyl, 0.5 mg/kg atracurium, and 1.5 mg/kg propofol for induction of anesthesia. Interventional group is receiving 1 mcg/kg dexmedetomidine infusion for induction of anesthesia for 10 minutes, and then infusion is fallowing up with 0.2 to 0.6 mg/kg/h based on tolerance of patient for MAP decreased in ICU after surgery until 24 hours. Study outcome: Evaluation and comparison of cardiac arrhythmia rate, hemodynamic changes, the urge to use anesthetic drugs, heart block, myocardial infarction, and cardiac arrest with heart monitoring in control and interventional groups during and after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016072413159N9
Registration date:2016-07-30, 1395/05/09
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-07-30, 1395/05/09
Registrant information
Name
Shima Sheybani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3764 7230
Email address
sheybanish@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Mashhad University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison the effectiveness of dexmedetomidine with midazolam on incidence of cardiac arrhythmia in off-pump coronary artery bypass surgery patients, a clinical trial.
Public title
The incidence of cardiac arrhythmia in coronary artery bypass surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients undergoing off-pump coronary artery bypass surgery; sustaining ASA I and ASA II; aged between 18-75 years; EF more than 35%.
Exclusion criteria: History of arrhythmias or heart block; EF less than 35%; history of cardiac surgery; history of valvular heart disease; having left atrial enlargement (LAE) or cardiomegaly.
Age
From 30 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Postal code
Approval date
2015-06-13, 1394/03/23
Ethics committee reference number
IR.MUMS.fm.REC.1394.704
Health conditions studied
1
Description of health condition studied
Cardiopulmonary bypass
ICD-10 code
I27.9
ICD-10 code description
Pulmonary heart disease, unspecified
Primary outcomes
1
Description
Cardiac arrhythmia rate
Timepoint
During and 24 hours after surgery
Method of measurement
Heart monitoring
Secondary outcomes
1
Description
Hemodynamic changes
Timepoint
During and 24 hours after surgery
Method of measurement
Heart monitoring
Intervention groups
1
Description
Control group: Patients are receiving 0.5 mg/kg midazolam addition of 10 mcg/kg fentanyl, 0.5 mg/kg atracurium, and 1.5 mg/kg propofol for induction of anesthesia. Cardiac arrhythmia rate and hemodynamic changes are measurement with heart monitoring during and after surgery.
Category
Treatment - Drugs
2
Description
Interventional group: Patients are receiving 1 mcg/kg dexmedetomidine infusion for induction of anesthesia for 10 minutes, and then infusion is fallowing up with 0.2 to 0.6 mg/kg/h based on tolerance of patient for MAP decreased in ICU after surgery until 24 hours. Cardiac arrhythmia rate and hemodynamic changes are measurement with heart monitoring during and after surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Shima Sheybani
Street address
Ghaem Hospital, Ahmadabad Avenue
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
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, Mashhad University of Medical Sciences