NCT03817112

Brief Summary

50 patients divided into 2 groups .Group I Dexmedetomidine infusion. Group II with Propofol infusion

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
Last Updated

January 25, 2019

Status Verified

January 1, 2019

Enrollment Period

1.3 years

First QC Date

January 23, 2019

Last Update Submit

January 23, 2019

Conditions

Regional Cerebral Tissue Oxygen Saturation

Keywords

cerebral oxygen saturationcardiopulmonary bypassdexmedetomidinepropofol

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

Infusion of dexmedetomidine

Drug: Dexmedetomidine Hydrochloride 0.1 MG/ML

Propofol

ACTIVE COMPARATOR

Propofol infusion

Drug: Propofol 10 MG/ML

Interventions

Dexmedetomidine Hydrochloride 0.1 MG/MLDRUG

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

Dexmedetomidine
Propofol 10 MG/MLDRUG

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

Propofol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams Cardiothoracic hospital

Cairo, Egypt

Location

MeSH Terms

Interventions

DexmedetomidinePropofol

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

January 23, 2019

First Posted

January 25, 2019

Study Start

June 15, 2017

Primary Completion

September 30, 2018

Study Completion

January 21, 2019

Last Updated

January 25, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)