Comparison of Propofol Based Versus Volatile Based Anesthesia and Postoperative Sedation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2013-07-31

Brief Summary

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All patients undergoing cardiac surgery require intraoperative anesthesia and short-term postoperative sedation with anesthetic agents after the procedure when patient is in the intensive care unit (ICU). The clinical data obtained so far are concentrating on intraoperative use volatile agents (preconditioning) resulting in better postoperative cardiac function and less release of biochemical markers of myocardial damage. There are no studies investigating whether postoperative use of volatile agents (post conditioning) in cardiac surgical population is improving outcomes. The aim of the present study is to compare total intravenous anesthesia and postoperative sedation versus total volatile anesthesia and postoperative sedation in cardiac surgical population.

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Detailed Description

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Conditions

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Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PA-Intravenous Sedation

Propofol based total intravenous anesthesia and postoperative sedation

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type OTHER

Propofol for sedation in the CVICU

Volatile sedation

Total inhalational anesthesia and postoperative sedation with the AnaConda device

Group Type ACTIVE_COMPARATOR

Isoflurane/sevoflurane

Intervention Type DRUG

Volatile for sedation in the CVICU while intubated

Interventions

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Isoflurane/sevoflurane

Volatile for sedation in the CVICU while intubated

Intervention Type DRUG

Propofol

Propofol for sedation in the CVICU

Intervention Type OTHER

Other Intervention Names

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2-chloro-2-(difluoromethoxy)-1,1,1-trifluoro-ethane 2,2,2-trifluoro-1-[trifluoromethyl]ethyl fluoromethyl ether Diprivan

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for coronary artery bypass graft surgery with good ventricular function (grade 1-2 ventricle)
* Signed informed consent

Exclusion Criteria

* Patients undergoing valvular surgery
* Severe kidney or liver disease (creatinine \> 2.5mg.dL-1 and bilirubin \> 2 mg.dL-1)
* Patients with known hypersensitivity to any of the trial drugs (propofol, volatile anesthetics), e.g. propofol allergy or malignant hyperthermia (induced by volatile anesthetics)
* Patient with poorly controlled diabetes or on oral anti-diabetic medication (inhibit preconditioning caused by volatile anesthetics)

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No