NCT03911544

Bispectral Index and Surgical Field

Does Bispectral Index Improve Surgical Conditions During Fast Track Gynecological Benign Laparoscopies

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Aalborg University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Consciousness Monitors
• Laparoscopy

Interventions

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

Timeline

• Start date: 2019-04-01
• Primary completion: 2021-03-08
• Completion: 2021-03-11
• First posted: 2019-04-11
• Last updated: 2021-07-20

Locations

1 site across 1 country: Denmark