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

NCT ID: NCT05778305

Last Updated: 2024-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-29

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Effect of Drug in CABAG Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

a central sympatholytic drug

control group

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

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type OTHER

saline is given to control group

Interventions

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Dexmedetomidine

a central sympatholytic drug

Intervention Type DRUG

normal saline

saline is given to control group

Intervention Type OTHER

Other Intervention Names

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precedex saline

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Rania Maher Hussien, MD

Associate professor of Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University

Cairo, Abassia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FMASU MD283/2022

Identifier Type: -

Identifier Source: org_study_id

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