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

October 7, 2024 updated by: Rania Maher Hussien, MD, Ain Shams University

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

Completed

Conditions

Intervention / Treatment

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 (Actual)

50

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Abassia
      • Cairo, Abassia, Egypt
        • Ain shams university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

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 (Estimated)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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