NCT02515019

Brief Summary

Electroencephalographic-based monitoring systems such as the bispectral index (BIS) may reduce anaesthetic overdose rates. The investigators hypothesised that goal-directed sevoflurane administration (guided by BIS monitoring) could reduce the sevoflurane plasma concentration (SPC) and intraoperative vasopressor doses during on-pump cardiac surgery in a prospective, controlled, sequential two-arm clinical study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 4, 2015

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

5 months

First QC Date

July 28, 2015

Last Update Submit

September 24, 2019

Conditions

Intraoperative Hypotension

Keywords

Anaesthetics inhalationBispectral indexCardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

  • Cumulative intraoperative administration of norepinephrine

    During operation

Secondary Outcomes (6)

  • Sevoflurane concentration in the oxygenator freshgas supply during cardiopulmonary bypass

    During operation

  • Postoperative blood lactate concentration

    Upon arrival in the intensive care unit (ICU)

  • Duration of postoperative mechanical ventilation

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

  • ICU length of stay

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

  • Incidence of acute kidney injury

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

  • +1 more secondary outcomes

Study Arms (2)

Group Sevo1.8%

NO INTERVENTION

Anaesthesia was maintained with a constant inspired concentration of sevoflurane 1.8% (Sevorane; Abbvie, Wiesbaden, Germany) administered via the ventilator. From the beginning of CPB, a constant flow of sevoflurane 1.8% was administered with the oxygenator fresh-gas supply, using a common anaesthetic vaporiser (Draeger Vapor Version 2000; Draeger, Luebeck, Germany). Following successful weaning from CPB, sevoflurane was again administered at an inspired concentration of 1.8% using the ventilator.

Bispectral index Monitoring

EXPERIMENTAL

The sevoflurane concentration via the ventilator and the oxygenator fresh gas supply was titrated to maintain a target BIS value between 40 and 60 (BIS-Monitor, Covidien, Boulder, Colorado, USA). However, the concentration of sevoflurane in the oxygenator fresh gas supply was not reduced below 0.3%.

Device: Bispectral index Monitoring

Interventions

Bispectral index MonitoringDEVICE

In group SevoBIS, the sevoflurane concentration was titrated to maintain a target BIS value between 40 and 60.

Also known as: BIS-Monitor, Covidien, Boulder, Colorado, USA
Bispectral index Monitoring

Eligibility Criteria

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

You may qualify if:

  • Undergoing elective on-pump cardiac surgery and an American Society of Anesthesiologists' (ASA) physical status of 3 to 4

You may not qualify if:

  • A contraindication to the administration of volatile anaesthetics, an active infection with a temperature more than 38°C and any history of neurological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center

Hamburg, 20246, Germany

Location

Related Links

Study Officials

  • Christian Zoellner, Professor

    Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Rainer Nitzschke

Study Record Dates

First Submitted

July 28, 2015

First Posted

August 4, 2015

Study Start

April 1, 2011

Primary Completion

September 1, 2011

Study Completion

January 1, 2012

Last Updated

September 26, 2019

Record last verified: 2019-09

Locations

DE(1)