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OpenTrials
Completed

NCT Number: NCT03817112

Effect of Dexmedetomidine and Propofol on Regional Cerebral Tissue Oxygen Saturation

50 patients divided into 2 groups

.Group I Dexmedetomidine infusion. Group II with Propofol infusion

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams Cardiothoracic hospital

Cairo, Egypt

About this study

: 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine Hydrochloride 0.1 MG/ML

Drug

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

Propofol 10 MG/ML

Drug

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jan 25, 2019
Registry last updated
Jan 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.