NCT01524354

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2010

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
Last Updated

September 12, 2012

Status Verified

September 1, 2012

Enrollment Period

1.8 years

First QC Date

January 30, 2012

Last Update Submit

September 11, 2012

Conditions

Heart Valve Diseases

Keywords

depth of anesthesiavalve surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • length of ICU stay

    7 days postoperatively

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Procedure: maintenance of anesthesia

cerebral state index

ACTIVE COMPARATOR

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

Procedure: maintenance of anesthesia

Interventions

maintenance of anesthesiaPROCEDURE

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

Also known as: Controlled anesthesia depth
cerebral state index

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • requirement of surgical correction of two or more valves

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Mikhail Y Kirov, MD, PhD

    Northern State Medical Univercity

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2012

First Posted

February 1, 2012

Study Start

March 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

September 12, 2012

Record last verified: 2012-09