Last reviewed · How we verify
NCT05946928: premidazolam
EMERGENCE AGITATION After Premedication IN PAEDIATRIC MAGNETIC RESONANCE IMAGING: A RETROSPECTIVE COHORT STUDY
trial in Autism Spectrum Disorder in 100 participants. Completed in 15 December 2022.
15 December 2022
Quick facts
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 1 March 2022 |
| Primary completion | 15 December 2022 |
| Estimated completion | 15 December 2022 |
| Sites | 1 location across Italy |
Conditions studied
- Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →
- Premedication — all drugs for Premedication →
- Brain Neoplasms — all drugs for Brain Neoplasms →
- Brain Pathology — all drugs for Brain Pathology →
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Who can join
Adults 1 to 10, any sex, with Autism Spectrum Disorder or Premedication. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of this study was to assess the anxiolytic and sedative effect of OZALIN® / OZASED® (ADV6209) 0,25mg/Kg in children undergoing magnetic resonance imaging (MRI) under inhalational anesthesia. Our hypothesis is that compared to children who do not receive any premedication, palatability of OZALIN® / OZASED® by allowing an easier acceptance of the drug, improves the quality of anesthesia induction and postoperative behavioral outcome improving sedation and reducing the need for inhalation anesthetic which has been recognized as the main cause of post-procedural behavioral changes, including emergence agitation.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Clinical Evaluation of Oral Midazolam Containing Cyclodextrin in Pediatric Magnetic Resonance: A Retrospective Cohort Study.
Garra R, Piersanti A, Del Vicario M, Pizzo CM, et al · · 2024 · PMID 38793054 · DOI 10.3390/jpm14050472
Verify or expand the search:
- PubMed search for NCT05946928
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 NCT05946928 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Last refreshed: 17 July 2023
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/NCT05946928.
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