Back to resultsA Comparison Between Ketamine-lidocaine Versus Ketamine-fentanyl for Induction on the Hemodynamic Effects in Patients With Coronary Artery Disease
Primary Purpose
Induction of General Anesthesia
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Fentanyl
Lidocaine IV
Sponsored by
About this trial
This is an interventional prevention trial for Induction of General Anesthesia
Eligibility Criteria
Inclusion Criteria:
- Participants will be patients with coronary artery disease and moderate to severe left ventricular dysfunction (ejection fraction < 40%), ASA physical status II-IV that will be scheduled for elective CABG surgery.
Exclusion Criteria:
- Patients with associated valvular heart disease, persistent arrhythmias, congestive cardiac failure, on mechanical ventilation, intra-aortic balloon pump (IABP), emergency surgery, and those with known allergy to any of the study's drugs, severe systemic non-cardiac disease; will be excluded from the study
Sites / Locations
- Kasr Al AinyRecruiting
- Kasr al ainyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lidocaine
Fentanyl
Arm Description
Outcomes
Primary Outcome Measures
incidence of hypotension
the number of patients who will develop hypotension
Secondary Outcome Measures
Full Information
NCT ID
NCT05502211
First Posted
August 12, 2022
Last Updated
October 19, 2022
Sponsor
Kasr El Aini Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05502211
Brief Title
A Comparison Between Ketamine-lidocaine Versus Ketamine-fentanyl for Induction on the Hemodynamic Effects in Patients With Coronary Artery Disease
Official Title
A Comparison Between Ketamine-lidocaine Versus Ketamine-fentanyl for Induction on the Hemodynamic Effects in Patients With Coronary Artery Disease and Left Ventricular Systolic Dysfunction :( A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Anticipated)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients with coronary artery disease (CAD) and left ventricular systolic dysfunction (LVSD) presenting for coronary artery bypass grafting (CABG) represent a high-risk group among the cardiac surgical population. Anesthetic management of these patients is challenging due to increased risk of perioperative hypotension and subsequently increased risk of postoperative morbidity and mortality. Post induction hypotension is a modifiable risk that can be largely prevented by adjusting the technique for anesthesia induction. There is no consensus on the use of certain anesthetic induction techniques for patients CAD and left ventricular dysfunction. Anesthesia induction techniques for cardiovascular surgery are usually based on considerations such as hemodynamic stability, effects on myocardial oxygen supply, and demand and minimizing intubation stress response.To the best of our knowledge, there is no previous data comparing the efficacy of adding lidocaine versus fentanyl to the induction of anesthesia with ketamine in patients with poor ventricular function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Induction of General Anesthesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine
Arm Type
Experimental
Arm Title
Fentanyl
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
induction of anaesthesia using fentanyl
Intervention Type
Drug
Intervention Name(s)
Lidocaine IV
Intervention Description
induction of anesthesia using lidocaine
Primary Outcome Measure Information:
Title
incidence of hypotension
Description
the number of patients who will develop hypotension
Time Frame
15 minutes post inductin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants will be patients with coronary artery disease and moderate to severe left ventricular dysfunction (ejection fraction < 40%), ASA physical status II-IV that will be scheduled for elective CABG surgery.
Exclusion Criteria:
Patients with associated valvular heart disease, persistent arrhythmias, congestive cardiac failure, on mechanical ventilation, intra-aortic balloon pump (IABP), emergency surgery, and those with known allergy to any of the study's drugs, severe systemic non-cardiac disease; will be excluded from the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayman Abougabal, MD
Phone
01020671408
Email
ayman.abougabal@kasralainy.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Nashaat
Phone
01229694414
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayman Abougabal, MD
Organizational Affiliation
lecturer of anesthesia Kasr Al Ainy hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Kasr Al Ainy
City
Cairo
ZIP/Postal Code
12566
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramy Alkonaesy, MD
Phone
01224883990
Facility Name
Kasr al ainy
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramy Alkonaesy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Comparison Between Ketamine-lidocaine Versus Ketamine-fentanyl for Induction on the Hemodynamic Effects in Patients With Coronary Artery Disease
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