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

Sponsor
Ain Shams University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05778305
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
11
Anticipated Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Effect of Dexmedetomidine on Stress-induced Changes in Hemodynamics and Left Ventricular Function in Coronary Artery Bypass Graft Surgery Outcome
Actual Study Start Date :
Jan 29, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Intra-operative ventricular function. [Intraoperative]

      global systolic function Ejection Fraction by TEE intraoperative

    2. post-operative ventricular function. [Up to 24 hours postoperative]

      global systolic function Ejection Fraction by TTE postoperative

    Secondary Outcome Measures

    1. hemodynamics [Immediate postoperative and up to 24 hours postoperative]

      Heart Rate (beat/minute),

    2. hemodynamics [Immediate postoperative and up to 24 hours postoperative]

      Mean arterial blood pressure (mmHg)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ain Shams University Cairo Abassia Egypt

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rania Maher Hussien, MD, Associate professor of Anesthesia, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT05778305
    Other Study ID Numbers:
    • FMASU MD283/2022
    First Posted:
    Mar 21, 2023
    Last Update Posted:
    Mar 21, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Dexmedetomidine

    Study Results

    No Results Posted as of Mar 21, 2023