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NCT04263844
Intranasal Dexmedetomidine Versus Intranasal Midazolam for Emergence Delirium Prevention
Phase 4 trial testing Intranasal dexmedetomidine in Emergence Delirium in 66 participants. Completed in 10 October 2019.
10 October 2019
Quick facts
| Lead sponsor | Indonesia University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 66 |
| Start date | 10 January 2019 |
| Primary completion | 10 October 2019 |
| Estimated completion | 10 October 2019 |
| Sites | 1 location across Indonesia |
Drugs / interventions tested
- Intranasal dexmedetomidine — full drug profile →
- Intranasal Midazolam — full drug profile →
Conditions studied
- Emergence Delirium — all drugs for Emergence Delirium →
Sponsor
Indonesia University
Who can join
Adults 1 to 12, any sex, with Emergence Delirium. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a double-blind clinical trial, in pediatric patients aged 1-12 years with physical status ASA (American Society of Anesthesiology) 1 and 2 who underwent eye surgery under general anesthesia using Sevoflurane inhalation agents, in investigator institution during February-May 2019.. There were 64 children obtained by consecutive sampling, who underwent eye surgery in investigator institution during February-May 2019. The subjects then grouped into dexmedetomidine group and midazolam group. Effectiveness was assessed from Emergence Delirium (ED) events, recovery time, and post-premedication desaturation events. Data analysis using Chi Square test and Mann-Whitney test.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Comparison of Efficacy of Premedication between Dexmedetomidine and Midazolam Intranasal for the Prevention of Emergence Delirium in Children Undergoing Ophthalmic Surgery.
Ramlan AAW, Mahri I, Firdaus R, Sugiarto A. · · 2021 · cited 5× · PMID 35110022 · DOI 10.5152/tjar.2021.1305
Verify or expand the search:
- PubMed search for NCT04263844
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Intranasal dexmedetomidine
Trials testing the same drug.
- NCT07324057 — The Effects of Preoperative Intranasal Administration of Dexmedetomidine and Esketamine on Negative Postoperative Behavi · NA · recruiting
- NCT07180095 — Children of Age 2-6years Undergoing Elective Surgery Will be Divided Into Two Groups Randomly. This Study Aims to Evalua · Phase 1, PHASE2 · not yet recruiting
- NCT07077200 — Comparison of Intranasal Dexmedetomidine and Short Video Viewing in the Preoperative Anxiety · completed
- NCT06741566 — Pre-operative Intra-nasal Dexmedetomidine or Insulin for Prevention of Early Post-operative Cognitive Dysfunction in Pat · EARLY_PHASE1 · not yet recruiting
- NCT06991647 — Effectiveness of Intranasal Dexmedetomidine Premedication in Child Intubation · Phase 3 · completed
Other recruiting trials for Emergence Delirium
Currently open trials in the same condition.
- NCT07435675 — Efficacy of Ultrasound-guided Greater Auricular Nerve Block in Preventing Postoperative Emergence Agitation in Pediatric · NA · recruiting
- NCT05541276 — MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children · Phase 3 · recruiting
- NCT07046364 — Remimazolam and Emergence Delirium in Pediatrics · Phase 4 · recruiting
- NCT06761092 — Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children · Phase 4 · active not recruiting
- NCT06545786 — Intraoperative Diagnosis of Neurocognitive Complications Via Electroencephalographic Analysis · recruiting
Other Indonesia University trials
Trials by the same sponsor.
- NCT07137130 — Secretome TGF Beta 3 · NA · not yet recruiting
- NCT07420335 — Preoperative Shoulder Exercises and Postoperative Inflammation, Pain, and Function After Modified Radical Mastectomy · NA · not yet recruiting
- NCT07278284 — The Effectiveness of Press Needle Acupuncture on Preoperative Anxiety in Tympanoplasty and Mastoidectomy · NA · recruiting
- NCT07337187 — Effect of Thread-Embedding Acupuncture at EX-B2 on Pain and Quality of Life in Chronic Low Back Pain · NA · not yet recruiting
- NCT07242001 — Laser Acupuncture for Otitis Media With Effusion in Children · NA · recruiting
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 NCT04263844 (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 Indonesia University
- Last refreshed: 12 February 2020
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