Comparison study of continuous infusion and bolus of Esmolol on hemodynamic response to laryngoscopy and endotracheal intubation in coronary artery bypass graft patients
Comparison of continuous infusion and bolus Esmolol on hemodynamic responses to laryngoscopy and endotracheal intubation in patients undergoing CABG surgery
Design
Randomized, double blind, phase 3 clinical trial on 66 patients
Settings and conduct
According to the criteria, after obtaining written consent, patients are randomly divided into study groups including: infusion group, bolus group and control group. Preoperative medical treatment continues until the morning of surgery. Age, sex, weight, height, chronic disease and medications are recorded.
After entering the operating room, patients are monitored by pulse oximeter, electrocardiogram and non-invasive blood pressure.To monitor blood pressure invasively, an intra-arterial catheter is inserted into the left radial artery after local injection of Lidocaine. Patients are intubated 3 minutes after induction of general anesthesia. HR and systolic blood pressure and diastolic blood pressure and mean blood pressure before infusion to induction, during and after induction of anesthesia, at laryngoscopy and endotracheal intubation and every minute for 10 minutes after endotracheal intubation are recorded.
Participants/Inclusion and exclusion criteria
Patients candidated for CABG elective surgery with ASA 2-4 and EF> 40%.
Intervention groups
Infusion group: 0.5 mg/kg Esmolol is injected within 4 minutes and then the infusion is started at 200 μg/kg/min and continues until endotracheal intubation. 0.9% Nacl is administered 2 minutes before endotracheal intubation.
Bolus group: 1.5mg/kg Esmolol is administered as a venous bolus 2 minutes before intubation and 0.9 Nacl% is administered 10 minutes before endotracheal intubation until it.
Control group: 0.9% Nacl infusion and bolus of normal saline are given instead of Esmolol.
Comparison study of continuous infusion and bolus of Esmolol on hemodynamic response to laryngoscopy and endotracheal intubation in coronary artery bypass graft patients
Public title
Continuous infusion of Esmolol in patients undergoing CABG surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ASA 2-4 undergoing elective CABG surgery
EF>40%
Exclusion criteria:
AV conduction block greater than grade 1
asthma
acute MI
HR<50
Mallampati score greater than 2
Kidney or liver failure
History of allergy or Idiosyncratic reaction to β-blockers
Systolic blood pressure less than 100 mmHg
Diastolic blood pressure less than 50 mmHg
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
66
Actual sample size reached:
75
Randomization (investigator's opinion)
Randomized
Randomization description
We are going to randomize based on Permuted block randomization method. In this way, all 6 groups of 3 groups (20 blocks) are determined and using the random number table, the number of blocks is selected and a sequence of groups A, B and c is determined and each patient is based on the entry number. The plot is placed in one of the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
After consciously agreeing to participate in the study, patients are randomly assigned to one of three study groups. researchers, evaluators of the outcome, and data Analyzer don't know about which patient is in which One of the treatment groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
5th of Qotb –e Ravandi Blvd. P.O.Box: 8715988141, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2015-05-24, 1394/03/03
Ethics committee reference number
IR.KAUMS.REC.1394.19
Health conditions studied
1
Description of health condition studied
Coronary artery disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
heart rate
Timepoint
HR and systolic blood pressure and diastolic blood pressure and mean blood pressure before infusion to induction, during and after induction of anesthesia, at laryngoscopy and endotracheal intubation and every minute for 10 minutes after endotracheal intubation are recorded.
Method of measurement
After entering the operating room, patients are monitored by pulse oximeter, electrocardiogram and non-invasive blood pressure.To monitor blood pressure invasively, an intra-arterial catheter is inserted into the left radial artery after local injection of Lidocaine.
2
Description
systolic blood pressure
Timepoint
HR and systolic blood pressure and diastolic blood pressure and mean blood pressure before infusion to induction, during and after induction of anesthesia, at laryngoscopy and endotracheal intubation and every minute for 10 minutes after endotracheal intubation are recorded.
Method of measurement
After entering the operating room, patients are monitored by pulse oximeter, electrocardiogram and non-invasive blood pressure.To monitor blood pressure invasively, an intra-arterial catheter is inserted into the left radial artery after local injection of Lidocaine.
3
Description
diastolic blood pressure
Timepoint
HR and systolic blood pressure and diastolic blood pressure and mean blood pressure before infusion to induction, during and after induction of anesthesia, at laryngoscopy and endotracheal intubation and every minute for 10 minutes after endotracheal intubation are recorded.
Method of measurement
After entering the operating room, patients are monitored by pulse oximeter, electrocardiogram and non-invasive blood pressure.To monitor blood pressure invasively, an intra-arterial catheter is inserted into the left radial artery after local injection of Lidocaine.
4
Description
mean blood pressure
Timepoint
HR and systolic blood pressure and diastolic blood pressure and mean blood pressure before infusion to induction, during and after induction of anesthesia, at laryngoscopy and endotracheal intubation and every minute for 10 minutes after endotracheal intubation are recorded.
Method of measurement
After entering the operating room, patients are monitored by pulse oximeter, electrocardiogram and non-invasive blood pressure.To monitor blood pressure invasively, an intra-arterial catheter is inserted into the left radial artery after local injection of Lidocaine.
Secondary outcomes
empty
Intervention groups
1
Description
Infusion group: 0.5 mg/kg Esmolol is injected within 4 minutes and then the infusion is started at 200 μg/kg/min and continues until endotracheal intubation. 0.9% Nacl is administered 2 minutes before endotracheal intubation. Esmolol is manufactured by Claris company, India.
Category
Treatment - Drugs
2
Description
Bolus group: 1.5mg/kg Esmolol is administered as a venous bolus 2 minutes before intubation and 0.9 Nacl% is administered 10 minutes before endotracheal intubation until it. Esmolol is manufactured by Claris company, India.
Category
Treatment - Drugs
3
Description
Control group: 0.9% Nacl infusion and bolus of normal saline are given instead of Esmolol.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital, Kashan
Full name of responsible person
Mohammadreza Sharif
Street address
5th of Qotb –e Ravandi Blvd. P.O.Box: 87159.1151, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0026
Email
beheshtihospital@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidreza Banafshe
Street address
5th of Qotb –e Ravandi Blvd. P.O.Box: 8715988141, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Hosein Akbari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biostatistics
Street address
5th of Qotb –e Ravandi Blvd. P.O.Box: 8715973449, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8715973449
Phone
+98 31 5554 0021
Email
akbari1350_h@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hosein Akbari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biostatistics
Street address
5th of Qotb –e Ravandi Blvd. P.O.Box: 8715973449, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8715973449
Phone
+98 31 5554 0021
Email
akbari1350_h@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Tobeiha
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
5th of Qotb –e Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5554 0021
Fax
Email
tobeiha-m@kaums.ac.ir
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available