Consciousness Monitors, Laparoscopy
Conditions
Keywords
Neuromuscular Agents, Bispectral Index
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.
Interventions
DEVICEBIS monitor
Participants allocated to the intervention group will receive TIVA anesthesia adjusted by the BIS monitoring in addition to clinical signs of poor anesthesia.
Sponsors
Aalborg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of optimal surgical field score | up to 12 hours | score 1 on a scale 1-4 (higher values represent a better outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Administration of neuromuscular block | up to 12 hours | Total amount of neuromuscolar block given during anesthesia, expressed in milligrams |
| Amount of anesthetics, narcotic analgesics and other adjuvants | up to 12 hours | Registration is in milligrams |
| BIS values (continues) | up to 12 hours | continues values |
| 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 |
| Amount of analgesics administered in PACU | 1 day | Registration is in milligrams |
Countries
Denmark
Outcome results
None listed