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Depth of Anesthesia in Cardiac Surgery

Primary Purpose

Heart Valve Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
maintenance of anesthesia
maintenance of anesthesia
Sponsored by
Northern State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Valve Diseases focused on measuring depth of anesthesia, valve surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • requirement of surgical correction of two or more valves

Exclusion Criteria:

  • no

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Control

    cerebral state index

    Arm Description

    Patients received maintenance of anesthesia with continuous infusion of propofol according to recommendations of the manufacturer.

    Patients received continuous infusion of propofol with rate maintaining cerebral state index (CSI) between 40 and 60 points.

    Outcomes

    Primary Outcome Measures

    duration of postoperative mechanical ventilation
    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
    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.

    Full Information

    First Posted
    January 30, 2012
    Last Updated
    September 11, 2012
    Sponsor
    Northern State Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01524354
    Brief Title
    Depth of Anesthesia in Cardiac Surgery
    Official Title
    Monitoring of Anesthetic Depth During Surgical Correction of Acquired Valvular Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2010 (undefined)
    Primary Completion Date
    December 2011 (Actual)
    Study Completion Date
    December 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Northern State Medical University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Valve Diseases
    Keywords
    depth of anesthesia, valve surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Patients received maintenance of anesthesia with continuous infusion of propofol according to recommendations of the manufacturer.
    Arm Title
    cerebral state index
    Arm Type
    Active Comparator
    Arm Description
    Patients received continuous infusion of propofol with rate maintaining cerebral state index (CSI) between 40 and 60 points.
    Intervention Type
    Procedure
    Intervention Name(s)
    maintenance of anesthesia
    Other Intervention Name(s)
    Controlled anesthesia depth
    Intervention Description
    intraoperative maintenance of anesthesia with propofol under control of cerebral state index at 40-60 points
    Intervention Type
    Procedure
    Intervention Name(s)
    maintenance of anesthesia
    Other Intervention Name(s)
    Controlled anesthesia depth
    Intervention Description
    intraoperative maintenance of anesthesia with propofol according to recommendations of the manufacturer
    Primary Outcome Measure Information:
    Title
    duration of postoperative mechanical ventilation
    Description
    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.
    Time Frame
    24 hours postoperatively
    Secondary Outcome Measure Information:
    Title
    length of ICU stay
    Description
    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.
    Time Frame
    7 days postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: requirement of surgical correction of two or more valves Exclusion Criteria: no
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mikhail Y Kirov, MD, PhD
    Organizational Affiliation
    Northern State Medical Univercity
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Depth of Anesthesia in Cardiac Surgery

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