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Bispectral Index Guided Sevoflurane Titration

Primary Purpose

Intraoperative Hypotension

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Bispectral index Monitoring
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intraoperative Hypotension focused on measuring Anaesthetics inhalation, Bispectral index, Cardiopulmonary bypass

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Group Sevo1.8%

Bispectral index Monitoring

Arm Description

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.

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%.

Outcomes

Primary Outcome Measures

Cumulative intraoperative administration of norepinephrine

Secondary Outcome Measures

Sevoflurane concentration in the oxygenator freshgas supply during cardiopulmonary bypass
Postoperative blood lactate concentration
Duration of postoperative mechanical ventilation
ICU length of stay
Incidence of acute kidney injury
Sevoflurane Plasma Concentration during CPB

Full Information

First Posted
July 28, 2015
Last Updated
September 24, 2019
Sponsor
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT02515019
Brief Title
Bispectral Index Guided Sevoflurane Titration
Official Title
Bispectral Index Guided Titration of Sevoflurane in On-pump Cardiac Surgery Reduces Plasma Sevoflurane Concentration and Vasopressor Requirements
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Electroencephalographic (EEG)-based monitoring systems, for example the bispectral index [(BIS); BIS monitor, Covidien, Boulder, Colorado, USA], were designed to prevent anaesthesia underdosage with the risk of awareness and to reduce the time to awakening after terminating general anaesthesia. However, little is known about the consequences of anaesthetic overdose. The investigators assume that high doses of anaesthetics result in cardiocirculatory depression and the necessity for high-dose vasopressor therapy, followed by microcirculation disorder and organ dysfunction. The investigators hypothesised that in on-pump cardiac-surgery, goaldirected administration of sevoflurane guided by BIS monitoring reduces excessive sevoflurane plasma concentration (SPC) and the need for an intraoperative vasopressor. To test this hypothesis, the current study compared BIS-guided sevoflurane administration with the constant delivery of an inspired sevoflurane concentration of 1.8% during on-pump cardiac surgery and analysed its effect on the SPC and the required intraoperative dosage of norepinephrine. The study population was divided into two patient groups: Thirty-three on-pump cardiac surgery patients enrolled in the study were allocated to a conventionally treated control group, with the constant administration of an inspired concentration of sevoflurane 1.8% (group Sevo1.8%). Thirty-four patients were sequentially allocated to an interventional group with BIS-guided administration of sevoflurane (group SevoBIS). Vasoactive drugs were administered according to the following protocol in both groups. If the mean arterial blood pressure decreased below 50 mmHg, a continuous infusion of norepinephrine was given to maintain a perfusion pressure between 50 and 60 mmHg during cardiopulmonary bypass. If the mean arterial pressure increased above 75 mmHg, nitroglycerine was used in boluses of 0.1 mg until arterial pressure returned to a mean of less than 75 mmHg. If mean arterial pressure persisted above 75 mmHg after a cumulative administration of nitroglycerine 1.0 mg, urapidil was administered in boluses of 0.1 mg/kg until the perfusion pressure decreased below 75 mmHg. At the end of the surgical procedure, all patients were transferred to the ICU.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Hypotension
Keywords
Anaesthetics inhalation, Bispectral index, Cardiopulmonary bypass

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Sevo1.8%
Arm Type
No Intervention
Arm Description
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.
Arm Title
Bispectral index Monitoring
Arm Type
Experimental
Arm Description
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%.
Intervention Type
Device
Intervention Name(s)
Bispectral index Monitoring
Other Intervention Name(s)
BIS-Monitor, Covidien, Boulder, Colorado, USA
Intervention Description
In group SevoBIS, the sevoflurane concentration was titrated to maintain a target BIS value between 40 and 60.
Primary Outcome Measure Information:
Title
Cumulative intraoperative administration of norepinephrine
Time Frame
During operation
Secondary Outcome Measure Information:
Title
Sevoflurane concentration in the oxygenator freshgas supply during cardiopulmonary bypass
Time Frame
During operation
Title
Postoperative blood lactate concentration
Time Frame
Upon arrival in the intensive care unit (ICU)
Title
Duration of postoperative mechanical ventilation
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Title
ICU length of stay
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Title
Incidence of acute kidney injury
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Title
Sevoflurane Plasma Concentration during CPB
Time Frame
During operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Undergoing elective on-pump cardiac surgery and an American Society of Anesthesiologists' (ASA) physical status of 3 to 4 Exclusion Criteria: A contraindication to the administration of volatile anaesthetics, an active infection with a temperature more than 38°C and any history of neurological disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Zoellner, Professor
Organizational Affiliation
Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center
City
Hamburg
ZIP/Postal Code
20246
Country
Germany

12. IPD Sharing Statement

Links:
URL
https://journals.lww.com/ejanaesthesiology/fulltext/2014/09000/Bispectral_index_guided_titration_of_sevoflurane.7.aspx#pdf-link
Description
Publication of study results - Bispectral index guided titration of sevoflurane in on-pump cardiac surgery reduces plasma sevoflurane concentration and vasopressor requirements: A prospective, controlled, sequential two-arm clinical study

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Bispectral Index Guided Sevoflurane Titration

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