Effect of Dexmedetomidine and Propofol on Regional Cerebral Tissue Oxygen Saturation

Regional Cerebral Tissue Oxygen Saturation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03817112
• Other study ID #: ASCSH86/17
• Status: Completed
• Phase: N/A
• Start date: June 15, 2017
• Est. completion date: January 21, 2019

Study information

• Verified date: January 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

50 patients divided into 2 groups

.Group I Dexmedetomidine infusion. Group II with Propofol infusion

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 21, 2019
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Regional Cerebral Tissue Oxygen Saturation

Intervention

Drug:
• Dexmedetomidine Hydrochloride 0.1 MG/ML
Dexmedetomidine Hydrochloride 0.1 MG/ML infusion at 0.2-0.7 mcg/kg/min
• Propofol 10 MG/ML
Propofol 10 MG/ML infusion at 0.3 -4 mg/kg/h

Locations

Country	Name	City	State
Egypt	Ain Shams Cardiothoracic hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive function assessment	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