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

Early Phase 1

Completed

• Conditions: Effect of Drug in CABAG Patients
• Interventions: Other: normal saline; Drug: Dexmedetomidine

• Registration Number: NCT05778305
• Lead Sponsor: Ain Shams University

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.

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 Timeline

• Study Start: 2023-01-29
• Study First Submitted: 2023-01-29
• Study First Submitted QC: 2023-03-19
• Study First Posted: 2023-03-21
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	normal saline	patients will receive the same volume of 0.9% saline infusion as loading and maintenance infusion.
Dexmedetomidine group	Dexmedetomidine	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

Primary Outcome Measures

Name	Time	Method
post-operative ventricular function.	Up to 24 hours postoperative	global systolic function Ejection Fraction by TTE postoperative
Intra-operative ventricular function.	Intraoperative	global systolic function Ejection Fraction by TEE intraoperative

Secondary Outcome Measures

Name	Time	Method
hemodynamics	Immediate postoperative and up to 24 hours postoperative	Mean arterial blood pressure (mmHg)

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Abassia, Egypt