NCT02727621

Brief Summary

Dexmedetomidine is a unique sedative anesthetic agent that allows accurate control of the depth of sedation and provides analgesia, cardio protection, renal protection, and neuroprotection without causing respiratory depression. It is an alpha 2-adrenoreceptor agonist that modulates the release of catecholamines from the central and autonomic nervous systems. When patients sedated by dexmedetomidine are allowed to become responsive, they are calm and cooperative (1). No other sedative agent has this feature, and sedated patients frequently awaken in a confused state. Investigators are conducting this study project to compare between dexmedetomidine based and propofol based anesthetic techniques with regard to hemodynamic changes, stress hormone release as well as cytokines in patients undergoing CPB for coronary revascularization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2016

Shorter than P25 for phase_2

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

First Submitted

Initial submission to the registry

March 30, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

5 months

First QC Date

March 30, 2016

Last Update Submit

September 25, 2016

Conditions

Coronary Artery Bypass Grafting

Keywords

DexmedetomidineCardiacCoronary Artery Bypass GraphtSedationPropofolIntravenous Anesthetics

Outcome Measures

Primary Outcomes (1)

  • cardiac index

    cardiac index measured in L/min/m2

    within intraoperative period

Secondary Outcomes (13)

  • heart rate

    within intraoperative period

  • mean arterial blood pressure

    within intraoperative period

  • central venous pressure

    within intraoperative period

  • pulmonary capillary wedge pressure

    within intraoperative period

  • mean pulmonary artery pressure

    within intraoperative period

  • +8 more secondary outcomes

Study Arms (2)

Dexmedetomidine group

ACTIVE COMPARATOR
Drug: Dexmedetomidine

Propofol group

ACTIVE COMPARATOR
Drug: propofol

Interventions

DexmedetomidineDRUG

Anesthesia will be maintained with continuous infusion of dexmedetomidine 0.5-0.7 µg/kg/h in addition to sevoflurane supplementation as required, to maintain arterial blood pressure and heart rate within 20% of preoperative values. Muscle relaxation will be maintained with continuous rocuronium infusion 0.6 mg/kg/h.

Also known as: precedex
Dexmedetomidine group
propofolDRUG

Anesthesia will be maintained with continuous infusion of propofol 50-100 µg/kg/min in addition to sevoflurane supplementation as required, to maintain arterial blood pressure and heart rate within 20% of preoperative values. Muscle relaxation will be maintained with continuous rocuronium infusion 0.6 mg/kg/h.

Also known as: diprivan
Propofol group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients scheduled for elective coronary revascularization surgery with cardiopulmonary bypass

You may not qualify if:

  • Severely impaired left ventricular function (ejection fraction \<40%)
  • Valvular heart disease
  • Low cardiac output syndrome
  • Uncontrolled rapid atrial fibrillation
  • On plavix less than one week
  • Severe systemic non-cardiac disease
  • Infectious disease
  • Poorly controlled diabetes mellitus
  • patients on corticosteroids or other immunosuppressive treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Asyut, Asyut Governorate, Egypt

Location

MeSH Terms

Interventions

DexmedetomidinePropofol

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Sayed Abd-Elshafy, MD

    Associate professor, anesthesia and critical care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University

Study Record Dates

First Submitted

March 30, 2016

First Posted

April 4, 2016

Study Start

April 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 27, 2016

Record last verified: 2016-09

Locations

EG(1)