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NCT04734418

Evaluation of Remifentanil and Dexmedetomidine in Patients With Noninvasive Mechanical Ventilation Intolerance

Status unknown NA Last updated 16 March 2021
What this trial tests

NA trial testing Remifentanil in NIV Intolerance in 178 participants. Status unknown.

Timeline
8 March 2021
Primary endpoint
31 January 2023
28 February 2023

Quick facts

Lead sponsorShanghai Zhongshan Hospital
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment178
Start date8 March 2021
Primary completion31 January 2023
Estimated completion28 February 2023
Sites1 location across China

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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:

Other trials of Remifentanil

Trials testing the same drug.

Other Shanghai Zhongshan Hospital trials

Trials by the same sponsor.

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Data sources for this page

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