Bispectral Index and Surgical Field

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Consciousness Monitors, Laparoscopy

Intervention / Treatment
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* Device: BIS monitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TIVA anesthesia with BIS monitoring<br>The depth of anesthesia will be adjusted with the help of BIS monitoring. | Device: BIS monitor<br>* Participants allocated to the intervention group will receive TIVA anesthesia adjusted by the BIS monitoring in addition to clinical signs of poor anesthesia.<br>|
| No Intervention: TIVA anesthesia without BIS monitoring<br>The depth of anesthesia will adjusted as in standard practice (clinical signs of poor anesthesia such as increase in blood pressure and/or heart rate, tearing and profuse sweating) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of optimal surgical field score | score 1 on a scale 1-4 (higher values represent a better outcome) | up to 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Administration of neuromuscular block | Total amount of neuromuscolar block given during anesthesia, expressed in milligrams | up to 12 hours | 
| Amount of anesthetics, narcotic analgesics and other adjuvants | Registration is in milligrams | up to 12 hours | 
| BIS values (continues) | continues values | 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 | 1 day | 
| Amount of analgesics administered in PACU | Registration is in milligrams | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuromuscular Agents, Bispectral Index