Monitoring of Adequate Course of General Anesthesia

Not Applicable

Completed

• Conditions: AAI Index; Monitoring of Depth of Anesthesia
• Interventions: Other: monitoring of the proper level of general anesthesia

• Registration Number: NCT03331692
• Lead Sponsor: Military Institute od Medicine National Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-20
• Primary Completion: 2013-08-30
• Study Completion: 2014-07-14
• Status Verified: 2017-10
• Study First Submitted: 2017-10-29
• Study First Submitted QC: 2017-11-02
• Last Update Submitted: 2017-11-02
• Study First Posted: 2017-11-06
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VA group	monitoring of the proper level of general anesthesia	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.
TIVA group	monitoring of the proper level of general anesthesia	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Anesthesiology and Intensive Therapy; 🇵🇱 Warsaw, Poland