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Depth of Anesthesia in Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT01524354
Recruitment Status : Completed
First Posted : February 1, 2012
Last Update Posted : September 12, 2012
Sponsor:
Information provided by (Responsible Party):
Northern State Medical University

Brief Summary:
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 or disease Intervention/treatment Phase
Heart Valve Diseases Procedure: maintenance of anesthesia Not Applicable

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  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Monitoring of Anesthetic Depth During Surgical Correction of Acquired Valvular Disorders
Study Start Date : March 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

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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 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • requirement of surgical correction of two or more valves

Exclusion Criteria:


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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01524354


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

Responsible Party: Northern State Medical University
ClinicalTrials.gov Identifier: NCT01524354     History of Changes
Other Study ID Numbers: Depth-28
First Posted: February 1, 2012    Key Record Dates
Last Update Posted: September 12, 2012
Last Verified: September 2012

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

Additional relevant MeSH terms:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Anesthetics
Propofol
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General