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Completed

NCT Number: NCT02515019

Bispectral Index Guided Sevoflurane Titration

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hamburg, 20246, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bispectral Index Monitoring

Device

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

Other names: BIS-Monitor, Covidien, Boulder, Colorado, USA

Primary outcomes

  1. Cumulative intraoperative administration of norepinephrine

    Time frame: During operation

Secondary outcomes

  1. Sevoflurane concentration in the oxygenator freshgas supply during cardiopulmonary bypass

    Time frame: During operation

  2. Postoperative blood lactate concentration

    Time frame: Upon arrival in the intensive care unit (ICU)

  3. Duration of postoperative mechanical ventilation

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

  4. ICU length of stay

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

  5. Incidence of acute kidney injury

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

  6. Sevoflurane Plasma Concentration during CPB

    Time frame: During operation

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

Bispectral Index Guided Titration of Sevoflurane in On-pump Cardiac Surgery Reduces Plasma Sevoflurane Concentration and Vasopressor Requirements

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Aug 4, 2015
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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