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NCT04734418
Evaluation of Remifentanil and Dexmedetomidine in Patients With Noninvasive Mechanical Ventilation Intolerance
NA trial testing Remifentanil in NIV Intolerance in 178 participants. Status unknown.
31 January 2023
Quick facts
| Lead sponsor | Shanghai Zhongshan Hospital |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 178 |
| Start date | 8 March 2021 |
| Primary completion | 31 January 2023 |
| Estimated completion | 28 February 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- Remifentanil — full drug profile →
- Dexmedetomidine (dexmedetomidine) — full drug profile →
Conditions studied
- NIV Intolerance — all drugs for NIV Intolerance →
Sponsor
Shanghai Zhongshan Hospital
Who can join
Adults 18 to 75, any sex, with NIV Intolerance. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Currently, NIV(Noninvasive ventilation ) is widely used in patients with hypoxemia and atelectasis after cardiac surgery.About 15% of patients have intolerance during NIV. The main manifestation is that the patient feels uncomfortable, often breaks away from the mask, and even gradually becomes agitated, which eventually leads to the failure of non-invasive ventilation.The patient's intubation rate is as high as 44%, and the mortality rate is 34%.There are many ways to prevent or treat NIV intolerance, of which the most used is to sedate the patient. This study aims to evaluate the effects of remifentanil and dexmedetomidine in the sedation of patients with intolerance to non-invasive mechanical ventilation after cardiac surgery, and to explore the optimal plan for sedation of patients with intolerant non-invasive mechanical ventilation after cardiac surgery.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Remifentanil versus Dexmedetomidine in Cardiac Surgery Patients with Noninvasive Ventilation Intolerance: Protocol for the REDNIVI Trial.
Luo MH, Hao GW, Liu K, Yin K, et al · · 2022 · cited 3× · PMID 35345251 · DOI 10.31083/j.rcm2303084 -
Remifentanil vs. dexmedetomidine for cardiac surgery patients with noninvasive ventilation intolerance: a multicenter randomized controlled trial.
Hao GW, Wu JQ, Yu SJ, Liu K, et al · · 2024 · cited 2× · PMID 39294818 · DOI 10.1186/s40560-024-00750-2 -
Postoperative glucocorticoids in patients with acute type A aortic dissection (GLAD): study protocol for a prospective, single-center, randomized controlled trial.
Deng YZ, Luo MH, Luo JC, Li JK, et al · · 2023 · cited 1× · PMID 37189085 · DOI 10.1186/s12871-023-02124-x
Verify or expand the search:
- PubMed search for NCT04734418
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Remifentanil
Trials testing the same drug.
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- NCT07301970 — Population Pharmacokinetics of Remifentanil in Low-Weight Critically Ill Patients · recruiting
- NCT07092384 — Effect of Remifentanil on Pruritus and Paresthesia of Fospropofol Disodium Anesthesia · NA · completed
- NCT06958393 — Effect of Opioid-free Anaesthesia on Postoperative Delirium in Elderly Patients Undergoing Gastrointestinal Surgery · Phase 4 · not yet recruiting
Other Shanghai Zhongshan Hospital 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 NCT04734418 (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 Shanghai Zhongshan Hospital
- Last refreshed: 16 March 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/NCT04734418.
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