Bispectral Index and Surgical Field

Aalborg University Hospital

Status: Completed

Conditions: Consciousness Monitors; Laparoscopy

Treatments: Device: BIS monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT03911544

20190006

Details and patient eligibility

About

This study investigates whether BIS monitor assisted anesthesia improves surgical space conditions during gynecological benign laparoscopic procedures.

Half of participants will receive BIS monitor assisted anesthesia, while the other half will receive anesthesia without BIS monitor.

Full description

General Anesthesia includes hypnosis/unconsciousness, amnesia, analgesia, muscle relaxation and autonomic and sensory blockade of responses to noxious stimulation.

Depth of anesthesia in standard practice is controlled by monitoring equipment such as blood pressure (BP), heart rate (HR), train of four ratio (TOF) and by clinical signs such as profuse sweating, tearing, cough and movements.

BIS can be used as additional tool to monitor and manage anesthesia. BIS is an empirically derived scale for measuring brain electrical activity. It computes an index between 0 and 100, whereas 0 corresponds to "no detectable brain electrical activity" (flatline EEG) and 100 to awake state. A patient is considered to be appropriately anesthetized when the BIS' value is between 40 and 60.

Enrollment: 160 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women aged > 18 years
• American Society of Anesthesiology (ASA) physical status 1 or 2
• Legally competent

Exclusion criteria

• Age < 18 years
• ASA physical status ≥3
• Renal and/or lever disease
• Relevant allergies towards anesthetics
• Cancer surgery
• No informed consent or inability to give that

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

TIVA anesthesia with BIS monitoring

Active Comparator group

Description:

The depth of anesthesia will be adjusted with the help of BIS monitoring.

Treatment:

Device: BIS monitor

TIVA anesthesia without BIS monitoring

No Intervention group

Description:

The depth of anesthesia will adjusted as in standard practice (clinical signs of poor anesthesia such as increase in blood pressure and/or heart rate, tearing and profuse sweating)