Effect of Dexmedetomidine and Propofol on Regional Cerebral Tissue Oxygen Saturation

January 23, 2019 updated by: Ayman Anis Metry, Ain Shams University

The Effect of Continuous Propofol Versus Dexmedetomidine Infusion on Regional Cerebral Tissue Oxygen Saturation During Cardiopulmonary Bypass

50 patients divided into 2 groups

.Group I Dexmedetomidine infusion. Group II with Propofol infusion

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

: 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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

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
      • Cairo, Egypt
        • Ain Shams Cardiothoracic hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexmedetomidine
Infusion of dexmedetomidine
Drug: Dexmedetomidine Hydrochloride 0.1 MG/ML
Dexmedetomidine Hydrochloride 0.1 MG/ML infusion at 0.2-0.7 mcg/kg/min
Active Comparator: Propofol
Propofol infusion
Drug: Propofol 10 MG/ML
Propofol 10 MG/ML infusion at 0.3 -4 mg/kg/h

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cognitive function assessment
Time Frame: 24 hours postoperative
Mini Mental State Examination Score (MMSE) test to assess orientation to time and place with ability to speak, think and draw. with highest ability 32 and lowest o
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)

June 15, 2017

Primary Completion (Actual)

September 30, 2018

Study Completion (Actual)

January 21, 2019

Study Registration Dates

First Submitted

January 23, 2019

First Submitted That Met QC Criteria

January 23, 2019

First Posted (Actual)

January 25, 2019

Study Record Updates

Last Update Posted (Actual)

January 25, 2019

Last Update Submitted That Met QC Criteria

January 23, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASCSH86/17

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

No

Studies a U.S. FDA-regulated device product

No

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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