Depth of Anesthesia in Cardiac Surgery

Heart Valve Diseases Clinical Trial

Official title:

Monitoring of Anesthetic Depth During Surgical Correction of Acquired Valvular Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01524354
• Other study ID #: Depth-28
• Status: Completed
• Phase: N/A
• First received: January 30, 2012
• Last updated: September 11, 2012
• Start date: March 2010
• Est. completion date: December 2011

Study information

• Verified date: September 2012
• Source: Northern State Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• requirement of surgical correction of two or more valves

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Valve Diseases

Intervention

Procedure:
• maintenance of anesthesia
intraoperative maintenance of anesthesia with propofol under control of cerebral state index at 40-60 points
• maintenance of anesthesia
intraoperative maintenance of anesthesia with propofol according to recommendations of the manufacturer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Northern State Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours postoperatively	No
Secondary	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.	7 days postoperatively	No