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Bispectral Index Guided Sevoflurane Titration

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02515019
Enrollment
60
Registered
2015-08-04
Start date
2011-04-30
Completion date
2012-01-31
Last updated
2019-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraoperative Hypotension

Keywords

Anaesthetics inhalation, Bispectral index, Cardiopulmonary bypass

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.

Interventions

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

Sponsors

Universitätsklinikum Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Cumulative intraoperative administration of norepinephrineDuring operation

Secondary

MeasureTime frame
Postoperative blood lactate concentrationUpon arrival in the intensive care unit (ICU)
Duration of postoperative mechanical ventilationParticipants will be followed for the duration of hospital stay, an expected average of 2 weeks
Sevoflurane concentration in the oxygenator freshgas supply during cardiopulmonary bypassDuring operation
Incidence of acute kidney injuryParticipants will be followed for the duration of hospital stay, an expected average of 2 weeks
Sevoflurane Plasma Concentration during CPBDuring operation
ICU length of stayParticipants will be followed for the duration of hospital stay, an expected average of 2 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026