Depth of Anesthesia in Cardiac Surgery

September 11, 2012 updated by: Northern State Medical University

Monitoring of Anesthetic Depth During Surgical Correction of Acquired Valvular Disorders

The aim of our study was to evaluate the significance of monitoring anesthetic depth for the conduct of anesthesia and the early postoperative period in patients subjected to surgical correction of combined valvular disorders.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Our aim was to evaluate the effect of monitoring anesthetic depth on duration of postoperative mechanical ventilation and ICU stay after surgical correction of combined valvular disorders.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

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:

  • requirement of surgical correction of two or more valves

Exclusion Criteria:

  • no

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control
Patients received maintenance of anesthesia with continuous infusion of propofol according to recommendations of the manufacturer.
Procedure: maintenance of anesthesia
intraoperative maintenance of anesthesia with propofol under control of cerebral state index at 40-60 points
Other Names:
  • Controlled anesthesia depth
Procedure: maintenance of anesthesia
intraoperative maintenance of anesthesia with propofol according to recommendations of the manufacturer
Other Names:
  • Controlled anesthesia depth
ACTIVE_COMPARATOR: cerebral state index
Patients received continuous infusion of propofol with rate maintaining cerebral state index (CSI) between 40 and 60 points.
Procedure: maintenance of anesthesia
intraoperative maintenance of anesthesia with propofol under control of cerebral state index at 40-60 points
Other Names:
  • Controlled anesthesia depth
Procedure: maintenance of anesthesia
intraoperative maintenance of anesthesia with propofol according to recommendations of the manufacturer
Other Names:
  • Controlled anesthesia depth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of postoperative mechanical ventilation
Time Frame: 24 hours postoperatively
Criteria for termination of postoperative respiratory support were the following: patient able to cooperate; adequate muscular tone; SpO2 > 95% with FiO2 0.5; PaCO2 < 45 mm Hg; postoperative bleeding rate < 50 mL hr-1; stable hemodynamics without inotropic/vasopressor support; body temperature of > 35 °C. Temporary pacing was not regarded as a contraindication for tracheal extubation.
24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of ICU stay
Time Frame: 7 days postoperatively
The time until 'fit for ICU discharge' criteria as well as the actual length of the ICU stay were registered. The 'fit for ICU discharge' criteria included the following: fully oriented patient, SaO2 > 90% on room air, no episodes of severe arrhythmias, bleeding < 50 mL hr-1, diuresis > 0.5 mL kg-1 hr-1, no need for inotropic/vasopressor support and no signs of ischemia on ECG.
7 days postoperatively

Collaborators and Investigators

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

Sponsor

Northern State Medical University

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

March 1, 2010

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

January 30, 2012

First Submitted That Met QC Criteria

January 30, 2012

First Posted (ESTIMATE)

February 1, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 12, 2012

Last Update Submitted That Met QC Criteria

September 11, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Depth-28

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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