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NCT03331692: MoDA
Monitoring of Adequate Course of General Anesthesia
NA trial testing monitoring of the proper level of general anesthesia in Monitoring of Depth of Anesthesia in 208 participants. Completed in 14 July 2014.
30 August 2013
Quick facts
| Lead sponsor | Military Institute od Medicine National Research Institute |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 208 |
| Start date | 20 April 2012 |
| Primary completion | 30 August 2013 |
| Estimated completion | 14 July 2014 |
| Sites | 1 location across Poland |
Drugs / interventions tested
- monitoring of the proper level of general anesthesia
Conditions studied
- Monitoring of Depth of Anesthesia — all drugs for Monitoring of Depth of Anesthesia →
- AAI Index — all drugs for AAI Index →
Sponsor
Military Institute od Medicine National Research Institute
Who can join
Adults 18 to 61, any sex, with Monitoring of Depth of Anesthesia or AAI Index. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03331692
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03331692 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Military Institute od Medicine National Research Institute
- Last refreshed: 6 November 2017
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