Effect of Dexmedetomidine and Propofol on Regional Cerebr... | NCT03817112

Studies
Effect of Dexmedetomidine and Propofol on Regional Cerebral Tissue Oxygen Saturation

NCT03817112

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Jan 25, 2019Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Regional Cerebral Tissue Oxygen Saturation

Interventions

Dexmedetomidine Hydrochloride 0.1 MG/ML
Propofol 10 MG/ML

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2017Actual

Primary Completion Date

Sep 30, 2018Actual

Completion Date

Jan 21, 2019Actual

First Submitted Date

Jan 23, 2019

First Submission Date that Met QC Criteria

Jan 23, 2019

First Posted Date

Jan 25, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2019

Last Update Posted Date

Jan 25, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

50 patients divided into 2 groups

.Group I Dexmedetomidine infusion. Group II with Propofol infusion

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dexmedetomidine	Active Comparator	Infusion of dexmedetomidine	Drug: Dexmedetomidine Hydrochloride 0.1 MG/ML
Propofol	Active Comparator	Propofol infusion	Drug: Propofol 10 MG/ML

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine Hydrochloride 0.1 MG/ML	Drug	Dexmedetomidine Hydrochloride 0.1 MG/ML infusion at 0.2-0.7 mcg/kg/min	Dexmedetomidine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams Cardiothoracic hospital		Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020927	Dexmedetomidine
D015742	Propofol

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided