CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 208 enrolled
Drug / intervention
monitoring of the proper level of general anesthesiaother
Likely dose
Not stated in record
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Search/NCT03331692
NCT03331692N/ACompleted

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

Military Institute od Medicine National Research Institute·interventional·Posted Nov 6, 2017·Updated Nov 6, 2017

In Brief

A clinical study evaluating monitoring of the proper level of general anesthesia for Monitoring of Depth of Anesthesia and AAI Index. Completed, enrolled 208 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPoland
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 6, 2017
Enrollment StartApr 20, 2012
Primary CompletionAug 30, 2013
Study CompletionJul 14, 2014
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 8.7 years ago

Interventions

monitoring of the proper level of general anesthesiaother

The monitoring of the adequate level of general anesthesia was performed both clinically and instrumentally.