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Monitoring of Adequate Course of General Anesthesia (MoDA)

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ClinicalTrials.gov Identifier: NCT03331692
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Dariusz Tomaszewski, Military Institute of Medicine, Poland

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.


Condition or disease Intervention/treatment Phase
Monitoring of Depth of Anesthesia AAI Index Other: monitoring of the proper level of general anesthesia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider)
Masking Description:

During the anesthesia, in all the participants an AAI-A line ARX index was continuously monitored. The electrodes were placed after the induction of anesthesia.

Intraoperatively, both auditory evoked potentials with AAI index and electroencephalogram with burst suppression analysis was recorded. Recorded data were blinded for anesthesiologists, so were not used for analysis of level of anesthesia during surgery.

Primary Purpose: Prevention
Official Title: A Comparison of Efficacy of Clinical Parameters With Auditory Evoked Potentials in Monitoring of Adequate Course of General Anesthesia
Actual Study Start Date : April 20, 2012
Actual Primary Completion Date : August 30, 2013
Actual Study Completion Date : July 14, 2014

Arm Intervention/treatment
TIVA group

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
The monitoring of the adequate level of general anesthesia was performed both clinically and instrumentally.
Other Names:
  • clinical monitoring
  • instrumental monitoring

VA group
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
The monitoring of the adequate level of general anesthesia was performed both clinically and instrumentally.
Other Names:
  • clinical monitoring
  • instrumental monitoring




Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 61 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331692


Locations
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Poland
Department of Anesthesiology and Intensive Therapy
Warsaw, Poland, 04-141
Sponsors and Collaborators
Military Institute of Medicine, Poland
Publications:
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Responsible Party: Dariusz Tomaszewski, Adjunct professor, Military Institute of Medicine, Poland
ClinicalTrials.gov Identifier: NCT03331692    
Other Study ID Numbers: 06101968-05
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs