Does Bispectral Index Improve Surgical Conditions During Fast Track Gynecological Benign Laparoscopies
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Consciousness Monitors
- Sponsor
- Aalborg University Hospital
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Proportion of optimal surgical field score
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Elena Crescioli
Principal Investigator
Aalborg University Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Proportion of optimal surgical field score
Time Frame: up to 12 hours
score 1 on a scale 1-4 (higher values represent a better outcome)
Secondary Outcomes
- Administration of neuromuscular block(up to 12 hours)
- Amount of analgesics administered in PACU(1 day)
- BIS values (continues)(up to 12 hours)
- Amount of anesthetics, narcotic analgesics and other adjuvants(up to 12 hours)
- Event of PONV (postoperative nausea and vomiting) and antiemetic administration in post-anesthesia care unit (PACU)(1 day)