Depth of Anesthesia in Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Northern State Medical University
ClinicalTrials.gov Identifier:
NCT01524354
First received: January 30, 2012
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Heart Valve Diseases
Procedure: maintenance of anesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Monitoring of Anesthetic Depth During Surgical Correction of Acquired Valvular Disorders

Resource links provided by NLM:


Further study details as provided by Northern State Medical University:

Primary Outcome Measures:
  • duration of postoperative mechanical ventilation [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • length of ICU stay [ Time Frame: 7 days postoperatively ] [ Designated as safety issue: No ]
    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.


Enrollment: 28
Study Start Date: March 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 according to recommendations of the manufacturer
Other Name: 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 Name: Controlled anesthesia depth

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • requirement of surgical correction of two or more valves

Exclusion Criteria:

  • no
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01524354

Sponsors and Collaborators
Northern State Medical University
Investigators
Study Director: Mikhail Y Kirov, MD, PhD Northern State Medical Univercity
  More Information

No publications provided

Responsible Party: Northern State Medical University
ClinicalTrials.gov Identifier: NCT01524354     History of Changes
Other Study ID Numbers: Depth-28
Study First Received: January 30, 2012
Last Updated: September 11, 2012
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by Northern State Medical University:
depth of anesthesia
valve surgery

Additional relevant MeSH terms:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 29, 2014