Monitoring of Adequate Course of General Anesthesia

Study Overview
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Brief Summary
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Clinical monitoring is the most common method of adjustment of the appropriate level of general anesthesia. However, the episodes of intraoperative awareness are still reported, suggesting that clinical observations may not be sufficient in some cases. The objective of the study was to compare the efficacy of clinical and instrumental neuromonitoring with auditory evoked potentials in intraoperative analysis of the proper level of general anesthesia. The patients scheduled for elective surgery were included into the study, and randomly divided into two groups. Patients in the first group (TIVA group) underwent intravenous, in the second group (VA group) underwent volatile anesthesia. The adequacy of anesthesia was analyzed with standard clinical parameters. All the participants were instrumentally monitored with AAI index. After the anesthesia patients received a questionnaire with the questions regarding possible intraoperative awareness.

Official Title
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A Comparison of Efficacy of Clinical Parameters With Auditory Evoked Potentials in Monitoring of Adequate Course of General Anesthesia

Conditions
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Monitoring of Depth of Anesthesia, AAI Index

Intervention / Treatment
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* Other: monitoring of the proper level of general anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients scheduled for ENT procedures or discectomy, preoperative health status I or II according to ASA score. Exclusion Criteria: patients below 18 or above 61 year old, ASA status III or higher, patients suffering from: (i) hearing problems or tinnitus, (ii) chronic inflammation of the ear, (iii) epilepsy, and (iv) mental disorders, pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 61 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are assigned to intravenous or volatile anesthesia. In both groups both the clinical and instrumental monitoring of the proper level of anesthesia was analyzed.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TIVA group<br>The participants scheduled for elective ENT procedures or for elective discectomy. The surgery was performed under totally intravenous anesthesia. During procedure, monitoring of the proper level of general anesthesia both clinical and instrumental was performed. | Other: monitoring of the proper level of general anesthesia<br>* The monitoring of the adequate level of general anesthesia was performed both clinically and instrumentally.<br>* Other names: instrumental monitoring;|
| Other: VA group<br>The participants scheduled for elective ENT procedures or for elective discectomy. The surgery was performed under volatile anesthesia. During procedure, monitoring of the proper level of general anesthesia both clinical and instrumental was performed. | Other: monitoring of the proper level of general anesthesia<br>* The monitoring of the adequate level of general anesthesia was performed both clinically and instrumentally.<br>* Other names: instrumental monitoring;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in AAI values in selected (16) time points. |  | T1: after premedication, just before the onset of anesthesia; T2: 30 seconds after intravenous administration of propofol; T3: just before the endotracheal intubation; T4: 60 seconds after the endotracheal intubation; T5: 5 minutes after the endotracheal |