Dexmedetomidine Sedation and Cardiopulmonary Bypass

September 25, 2016 updated by: Sayed Kaoud Abd-Elshafy, Assiut University

Dexmedetomidine Based Versus Propofol Based Anesthesia in Patients Undergoing Coronary Revascularization: a Randomized, Double-blind Controlled Study

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.

Study Overview

Status

Completed

Detailed Description

100 patients undergoing elective CPB for coronary revascularization surgery. On the morning of operation the patients were randomized to receive one of two anesthetic techniques dependent on the type of sedation used. Standard anesthetic technique will be used for all patients except for using dexmedetomidine sedation in one group and propofol sedation in the other group.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Assiut, Egypt
        • Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients scheduled for elective coronary revascularization surgery with cardiopulmonary bypass

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Propofol group
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.
Other Names:
  • diprivan
Active Comparator: Dexmedetomidine group
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.
Other Names:
  • precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiac index
Time Frame: within intraoperative period
cardiac index measured in L/min/m2
within intraoperative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
heart rate
Time Frame: within intraoperative period
heart rate measured in beat/min.
within intraoperative period
mean arterial blood pressure
Time Frame: within intraoperative period
mean arterial blood pressure measured in mm.Hg
within intraoperative period
central venous pressure
Time Frame: within intraoperative period
central venous pressure measured in mm.Hg
within intraoperative period
pulmonary capillary wedge pressure
Time Frame: within intraoperative period
pulmonary capillary wedge pressure measured in mm.Hg
within intraoperative period
mean pulmonary artery pressure
Time Frame: within intraoperative period
mean pulmonary artery pressure measure in mm.Hg
within intraoperative period
systemic vascular resistance index
Time Frame: within intraoperative period
systemic vascular resistance index measured in dyn.sec/cm5/m2
within intraoperative period
pulmonary vascular resistance index
Time Frame: within intraoperative period
pulmonary vascular resistance index measured in dyn.sec/cm5/m2
within intraoperative period
stroke volume index
Time Frame: within intraoperative period
stroke volume index measured in ml/m2/beat
within intraoperative period
left ventricular stroke work index
Time Frame: within intraoperative period
left ventricular stroke work index measured in gm/m2/beat
within intraoperative period
cardiac output
Time Frame: within intraoperative period
cardiac output measured in L/min
within intraoperative period
inotrope score
Time Frame: 1st 24 hours
appropriate score
1st 24 hours
duration of mechanical ventilation
Time Frame: 1st week
duration of mechanical ventilation measured in hours
1st week
sedation score
Time Frame: 1st 24 hours
appropriate score
1st 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sayed Abd-Elshafy, MD, Associate professor, anesthesia and critical care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

March 30, 2016

First Submitted That Met QC Criteria

April 1, 2016

First Posted (Estimate)

April 4, 2016

Study Record Updates

Last Update Posted (Estimate)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 25, 2016

Last Verified

September 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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