A Comparison Between Ketamine-lidocaine Versus Ketamine-fentanyl for Induction on the Hemodynamic Effects in Patients With Coronary Artery Disease

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

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.

Study Overview

• Status: Recruiting
• Conditions: Induction of General Anesthesia
• Intervention / Treatment: Drug: Lidocaine IV; Drug: Fentanyl

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ayman Abougabal, MD; Phone Number: 01020671408; Email: ayman.abougabal@kasralainy.edu.eg
• Study Contact Backup: Name: Monica Nashaat; Phone Number: 01229694414

Study Locations

• Egypt
  • Cairo, Egypt, 12566
    • Recruiting
    • Kasr AL Ainy
    • Contact: Ramy Alkonaesy, MD; Phone Number: 01224883990
  • Cairo, Egypt
    • Recruiting
    • Kasr AL Ainy
    • Contact: Ramy Alkonaesy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fentanyl	Drug: Fentanyl; induction of anaesthesia using fentanyl
Experimental: Lidocaine	Drug: Lidocaine IV; induction of anesthesia using lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of hypotension	the number of patients who will develop hypotension	15 minutes post inductin

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital
• Investigators: Study Chair: Ayman Abougabal, MD, lecturer of anesthesia Kasr Al Ainy hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: August 12, 2022
• First Submitted That Met QC Criteria: August 12, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Actual): October 20, 2022
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Membrane Transport Modulators; Adjuvants, Anesthesia; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Fentanyl; Lidocaine
• Other Study ID Numbers: MS-230-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No