Effect of Dexmedetomidine on Left Ventricular Function in Coronary Artery Bypass Graft Surgery Outcome

NCT05778305 | Completed Early Phase 1 FDA Drug

• 1 other identifier: FMASU MD283/2022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

50 patients of both sexes undergoing elective CABG surgery will be randomly divided into 2 groups, study group (Dex) group and control group (C) to determine the effect of dexmedetomidine on the peri-operative hemodynamic changes during CABG surgery.

Conditions

Effect of Drug in CABAG Patients

Outcome Measures

Primary Outcomes (2)

• Intra-operative ventricular function.

  global systolic function Ejection Fraction by TEE intraoperative

  Intraoperative

• post-operative ventricular function.

  global systolic function Ejection Fraction by TTE postoperative

  Up to 24 hours postoperative

Secondary Outcomes (2)

• hemodynamics

  Immediate postoperative and up to 24 hours postoperative

• hemodynamics

  Immediate postoperative and up to 24 hours postoperative

Study Arms (2)

Dexmedetomidine group

ACTIVE COMPARATOR

patients will have loading Dexmedetomidine( 1ug/kg) over 10 minutes followed by continuous infusion of (0.5ug/kg/hr) from the initiation of anaesthesia up to extubation in the ICU. Patients will not be extubated until completely awake and have no sign of arrhythmias and bleeding

Drug: Dexmedetomidine

control group

PLACEBO COMPARATOR

patients will receive the same volume of 0.9% saline infusion as loading and maintenance infusion.

Other: normal saline

Interventions

Dexmedetomidine DRUG

a central sympatholytic drug

Also known as: precedex

Dexmedetomidine group

normal saline OTHER

saline is given to control group

Also known as: saline

control group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• undergoing elective CABG surgery

You may not qualify if:

• Patient refusal
• Dementia patients
• Poor ventricular function with ejection fraction below 40%
• Asthmatic patients
• Uncontrolled diabetic patients with HbA1c above 8
• Combined surgeries (CABG+ valves)
• Emergency surgeries.
• Pre-existing arrhythmia
• Patients with renal impairment
• Patients with hepatic impairment
• Patients with heart block
• Off-pump CABG

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Abassia, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Saline Solution; Sodium Chloride

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Anesthesia

Study Record Dates

• First Submitted: January 29, 2023
• First Posted: March 21, 2023
• Study Start: January 29, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)