Bispectral Index and Surgical Field

Not Applicable

Completed

• Conditions: Consciousness Monitors; Laparoscopy
• Interventions: Device: BIS monitor

• Registration Number: NCT03911544
• Lead Sponsor: Aalborg University Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-04-06
• Study First Submitted QC: 2019-04-10
• Study First Posted: 2019-04-11
• Primary Completion: 2021-03-08
• Study Completion: 2021-03-11
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-18
• Last Update Posted: 2021-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TIVA anesthesia with BIS monitoring	BIS monitor	The depth of anesthesia will be adjusted with the help of BIS monitoring.

Primary Outcome Measures

Name	Time	Method
Proportion of optimal surgical field score	up to 12 hours	score 1 on a scale 1-4 (higher values represent a better outcome)

Secondary Outcome Measures

Name	Time	Method
Administration of neuromuscular block	up to 12 hours	Total amount of neuromuscolar block given during anesthesia, expressed in milligrams
Amount of analgesics administered in PACU	1 day	Registration is in milligrams
BIS values (continues)	up to 12 hours	continues values
Amount of anesthetics, narcotic analgesics and other adjuvants	up to 12 hours	Registration is in milligrams
Event of PONV (postoperative nausea and vomiting) and antiemetic administration in post-anesthesia care unit (PACU)	1 day	Registration of the drugs in in milligrams

Trial Locations

Locations (1)

Aalborg University Hospital; 🇩🇰 Aalborg, North Jutland Region, Denmark