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NCT02656901
Incidence of Early Postoperative Cognitive Dysfunction After Closed Loop Anesthesia vs Inhalational Anesthesia or TIVA
NA trial testing auto total endovenous anesthesia in Postoperative Cognitive Dysfunction in 132 participants. Completed in 1 June 2016.
1 May 2016
Quick facts
| Lead sponsor | University of Foggia |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | screening |
| Enrollment | 132 |
| Start date | 1 January 2016 |
| Primary completion | 1 May 2016 |
| Estimated completion | 1 June 2016 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- auto total endovenous anesthesia
- Manual Desflurane anesthesia
- Manual Sevoflurane anesthesia
- Manual total endovenous anesthesia
Conditions studied
- Postoperative Cognitive Dysfunction — all drugs for Postoperative Cognitive Dysfunction →
Sponsor
University of Foggia
Who can join
18 and older, any sex, with Postoperative Cognitive Dysfunction. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Change from baseline of the Mini-Mental test examination score 15 min post anesthesia
Time frame: 15 minutes before anesthetic procedures and 15 min after the end of general anesthesia
The Mini-Mental State Examination (MMSE) test will be given 15 min before the anesthetic procedure and 15 min after the end of anesthesia.
Sponsor's own description
This study is designed to test the hypothesis that closed loop system reduces post operative cognitive dysfunction incidence 15 min after anesthesia more than desflurane, sevorane, total intravenous anesthesia manually guided by bispectral index in urologic surgical patients. The secondary aim is to evaluate the postoperative cognitive impairment in in elderly vs younger surgical patients.
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 NCT02656901
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Foggia trials
Trials by the same sponsor.
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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 NCT02656901 (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 University of Foggia
- Last refreshed: 3 July 2016
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02656901.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing