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

Effect of Dexmedetomidine on Stress-induced Changes in Hemodynamics and Left Ventricular Function in Coronary Artery Bypass Graft Surgery Outcome

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.

Study Overview

• Status: Recruiting
• Conditions: Effect of Drug in CABAG Patients
• Intervention / Treatment: Drug: Dexmedetomidine; Other: normal saline

Detailed Description

The effect of dexmedetomidine during CABG surgery is studied regarding Ventricular function, pre bypass and post bypass using the transoeophageal echo (TEE), post-operative by transthoracic echocardiography (TTE) on day of surgery and after extubation.

Incidence of intraoperative and post operative ischemia and arrhythmias using Electrocardiogram (ECG) as well as the length of ICU and hospital stay.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Rania M Hussien, professor; Phone Number: 026213948; Email: drrania_maamon@med.asu.edu.eg
• Study Contact Backup: Name: fathy Tash, professor; Phone Number: 26857539; Email: fathytash@yahoo.com

Study Locations

• Egypt
  • Abassia
    • Cairo, Abassia, Egypt
      • Recruiting
      • ain shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• undergoing elective CABG surgery

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexmedetomidine group; 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; a central sympatholytic drug; Other Names: precedex
Placebo Comparator: control group; patients will receive the same volume of 0.9% saline infusion as loading and maintenance infusion.	Other: normal saline; saline is given to control group; Other Names: saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
hemodynamics	Heart Rate (beat/minute),	Immediate postoperative and up to 24 hours postoperative
hemodynamics	Mean arterial blood pressure (mmHg)	Immediate postoperative and up to 24 hours postoperative

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: January 29, 2023
• First Submitted That Met QC Criteria: March 19, 2023
• First Posted (Actual): March 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 19, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: FMASU MD283/2022

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: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes