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Completed

NCT Number: NCT01524354

Depth of Anesthesia in Cardiac Surgery

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.

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Key information

Conditions

Heart Valve Diseases Cardiovascular Diseases Heart Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • requirement of surgical correction of two or more valves

Exclusion criteria

  • no

Treatment and study plan

maintenance of anesthesia

Procedure

intraoperative maintenance of anesthesia with propofol under control of cerebral state index at 40-60 points

Other names: Controlled anesthesia depth

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Northern State Medical University

Other

Registry information

Official study title

Monitoring of Anesthetic Depth During Surgical Correction of Acquired Valvular Disorders

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 1, 2012
Registry last updated
Sep 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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