Effect of Dexmedetomidine and Propofol on Regional Cerebral Tissue Oxygen Saturation

NCT ID: NCT03817112

Last Updated: 2019-01-25

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

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-15

Study Completion Date

2019-01-21

Brief Summary

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50 patients divided into 2 groups

.Group I Dexmedetomidine infusion. Group II with Propofol infusion

Detailed Description

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: 50 patients anticipated for open heart surgeries were encompassed in the study. Patients were divided into 2 groups, group P (receiving propofol) and group D (receiving dexmedetomidine) during CPB. Both groups were studied for variations in right and left rScO2 as well as postoperative cognitive dysfunction using the Mini Mental State Examination Score (MMSE) test.

Conditions

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Regional Cerebral Tissue Oxygen Saturation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Dexmedetomidine

Infusion of dexmedetomidine

Group Type ACTIVE_COMPARATOR

Dexmedetomidine Hydrochloride 0.1 MG/ML

Intervention Type DRUG

Dexmedetomidine Hydrochloride 0.1 MG/ML infusion at 0.2-0.7 mcg/kg/min

Propofol

Propofol infusion

Group Type ACTIVE_COMPARATOR

Propofol 10 MG/ML

Intervention Type DRUG

Propofol 10 MG/ML infusion at 0.3 -4 mg/kg/h

Interventions

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Dexmedetomidine Hydrochloride 0.1 MG/ML

Dexmedetomidine Hydrochloride 0.1 MG/ML infusion at 0.2-0.7 mcg/kg/min

Intervention Type DRUG

Propofol 10 MG/ML

Propofol 10 MG/ML infusion at 0.3 -4 mg/kg/h

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing valve surgeries
* Patients undergoing on pump coronary artery bypass grafting surgeries

Exclusion Criteria

* emergency cases, patients with cervical spine pathology (cervical stenosis, cervical disc herniation, carotid stenosis), patients with cerebral pathology (cerebral strokes, ischemic attacks), patients with Mini Mental State Examination Score (MMSE) of 23 or less, complicated cases with prolongation of the cardiopulmonary bypass period, patients needing moderate hypothermia
Minimum Eligible Age

18 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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Ayman Anis Metry

Clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams Cardiothoracic hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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ASCSH86/17

Identifier Type: -

Identifier Source: org_study_id

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