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NCT Number: NCT03331692

Monitoring of Adequate Course of General Anesthesia

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.

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Key information

Conditions

Monitoring of Depth of Anesthesia AAI Index

Age range

18 year–61 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Intensive Therapy

Warsaw, 04-141, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

monitoring of the proper level of general anesthesia

Other

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

Other names: clinical monitoring, instrumental monitoring

Primary outcomes

  1. Changes in AAI values in selected (16) time points.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Military Institute od Medicine National Research Institute

Other

Registry information

Official study title

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

Acronym: MoDA

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Nov 6, 2017
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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