Monitoring of Adequate Course of General Anesthesia (MoDA)

Military Institute od Medicine National Research Institute

Status: Completed

Conditions: AAI Index; Monitoring of Depth of Anesthesia

Treatments: Other: monitoring of the proper level of general anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT03331692

06101968-05

Details and patient eligibility

About

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.

Enrollment: 208 patients

Sex: All

Ages: 18 to 61 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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208 participants in 2 patient groups

TIVA group

Other group

Description:

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.

Treatment:

Other: monitoring of the proper level of general anesthesia

VA group

Other group

Description:

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.

Treatment:

Other: monitoring of the proper level of general anesthesia