Bispectral Index Guided Sevoflurane Titration

Not Applicable

Completed

• Conditions: Intraoperative Hypotension
• Interventions: Device: Bispectral index Monitoring

• Registration Number: NCT02515019
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2011-09
• Study Completion: 2012-01
• Study First Submitted: 2015-07-28
• Study First Submitted QC: 2015-07-30
• Study First Posted: 2015-08-04
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bispectral index Monitoring	Bispectral index Monitoring	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%.

Primary Outcome Measures

Name	Time	Method
Cumulative intraoperative administration of norepinephrine	During operation

Secondary Outcome Measures

Name	Time	Method
Incidence of acute kidney injury	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Postoperative blood lactate concentration	Upon arrival in the intensive care unit (ICU)
ICU length of stay	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Sevoflurane concentration in the oxygenator freshgas supply during cardiopulmonary bypass	During operation
Duration of postoperative mechanical ventilation	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Sevoflurane Plasma Concentration during CPB	During operation

Trial Locations

Locations (1)

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