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

NCT05502211 | Unknown

• 1 other identifier: MS-230-2022
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Induction of General Anesthesia

Outcome Measures

Primary Outcomes (1)

• incidence of hypotension

  the number of patients who will develop hypotension

  15 minutes post inductin

Study Arms (2)

Lidocaine

EXPERIMENTAL

Drug: Lidocaine IV

Fentanyl

ACTIVE COMPARATOR

Drug: Fentanyl

Interventions

Fentanyl DRUG

induction of anaesthesia using fentanyl

Fentanyl

Lidocaine IV DRUG

induction of anesthesia using lidocaine

Lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (2)

Kasr Al Ainy

Cairo, 12566, Egypt

RECRUITING

Kasr al ainy

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ayman Abougabal, MD

  lecturer of anesthesia Kasr Al Ainy hospital

  STUDY CHAIR

Central Study Contacts

Ayman Abougabal, MD

CONTACT

01020671408; ayman.abougabal@kasralainy.edu.eg

Monica Nashaat

CONTACT

01229694414

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Abougabal

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 16, 2022
• Study Start: November 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)