Dexmedetomidine Sedation and Cardiopulmonary Bypass

Coronary Artery Bypass Grafting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02727621
• Other study ID #: IRB000087801
• Status: Completed
• Phase: Phase 2
• First received: March 30, 2016
• Last updated: September 25, 2016
• Start date: April 2016
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Bypass Grafting

Intervention

Drug:
• Dexmedetomidine
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.
• propofol
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.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

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