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NCT04399343: DEPOD
Dexmedetomidine for Prevention of Postoperative Delirium After Intracranial Operation for Brain Tumor
Phase 4 trial testing Dexmedetomidine in Central Nervous System Diseases in 700 participants. Status unknown.
1 August 2021
Quick facts
| Lead sponsor | Capital Medical University |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 700 |
| Start date | 1 March 2021 |
| Primary completion | 1 August 2021 |
| Estimated completion | 1 October 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- Dexmedetomidine (dexmedetomidine) — full drug profile →
- Normal saline
Conditions studied
- Central Nervous System Diseases — all drugs for Central Nervous System Diseases →
Sponsor
Capital Medical University
Who can join
18 and older, any sex, with Central Nervous System Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Postoperative delirium is common after major surgery, and is associated with adverse outcomes. Systematic reviews and meta-analyses of randomized controlled trials have shown that perioperative administration of dexmedetomidine may decrease the incidence of postoperative delirium in patients after either cardiac or non-cardiac surgery. However, neurosurgical patients are often excluded in clinical trials of postoperative delirium. In this prospective, multicenter, randomized, double-blinded, and placebo-controlled trial with two parallel arms, ICU admitted adult patients after intracranial operation for brain tumor will be enrolled. Low-dose dexmedetomidine will be applied during the early postoperative phase. The investigators aim to evaluate the efficacy and safety of low-dose dexmedetomidine for prevention of postoperative delirium in this patient population. The primary hypothesis is that, compared to the placebo group, the prophylactic use of low-dose dexmedetomidine can decrease the incidence of postoperative delirium without significant adverse events in patients after intracranial operation for brain tumor.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Dexmedetomidine for the prevention of postoperative delirium in patients after intracranial operation for brain tumours (DEPOD study): a study protocol and statistical plan for a multicentre randomised controlled trial.
He X, Cheng KM, Zhang L, Gu H, et al · · 2020 · cited 2× · PMID 33234648 · DOI 10.1136/bmjopen-2020-040939
Verify or expand the search:
- PubMed search for NCT04399343
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Capital Medical University 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 NCT04399343 (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 Capital Medical University
- Last refreshed: 28 January 2021
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/NCT04399343.
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