Bispectral Index and Surgical Field

Aalborg University Hospital160 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

160

Conditions

Consciousness Monitors Laparoscopy

Interventions

BIS monitorDEVICE

Participants allocated to the intervention group will receive TIVA anesthesia adjusted by the BIS monitoring in addition to clinical signs of poor anesthesia.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Aalborg University Hospital

Aalborg, North Denmark, Denmark

Outcomes

Primary Outcomes

Proportion of optimal surgical field score

score 1 on a scale 1-4 (higher values represent a better outcome)

Time frame: up to 12 hours

Secondary Outcomes

Administration of neuromuscular block

Total amount of neuromuscolar block given during anesthesia, expressed in milligrams

Time frame: up to 12 hours

Amount of anesthetics, narcotic analgesics and other adjuvants

Registration is in milligrams

Time frame: up to 12 hours

BIS values (continues)

continues values

Time frame: up to 12 hours

Event of PONV (postoperative nausea and vomiting) and antiemetic administration in post-anesthesia care unit (PACU)

Registration of the drugs in in milligrams

Time frame: 1 day

Amount of analgesics administered in PACU

Registration is in milligrams

Time frame: 1 day

Data from ClinicalTrials.gov

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