A Phase 2 interventional study of Remimazolam 20 MG Injection [Byfavo] and NaCl 0.9% in Remimazolam, Emergence Delirium and Rhinoplasty, sponsored by University Hospital of Split. Recruiting at 1 site in Croatia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-03.
Sponsored by University Hospital of Split · Phase 2, Interventional, and Prevention
The aim of this research is to confirm the effectiveness of remimazolam in preventing delirium during recovery from anesthesia in adult patients who have undergone one of the rhinological surgeries (septoplasty, rhinoseptoplasty or functional endoscopic sinus surgery).
Patients aged 18-65, ASA classification I-II will be anesthetized with balanced anesthesia maintained with sevoflurane and will be randomized into two groups. The first group will receive remimazolam before anesthesia, while the second will receive normal saline solution.
The main outcome of the study will be the presence/absence of delirium during anesthesia recovery, while the secondary outcome will be the postoperative pain level, the length of stay in the recovery room, the presence of unwanted events in the recovery room, and the presence of postoperative mood changes.
751 studies on the registry are indexed under Emergence Delirium; 262 are open to participants now.
This study's planned enrollment of 80 is below the median of 120 across 464 interventional studies indexed under Emergence Delirium.
Browse Emergence Delirium studies →University Hospital of Split is the lead sponsor of 31 studies on the registry; 9 are open to participants now.
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The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Remimazolam 20 MG Injection [Byfavo]
Drug: NaCl 0.9%
Remimazolam 0.1 mg/kg intravenous injection
NaCl 0.9% 0.04 mL/kg
Richmond agitation sedation scale
Time frame: Immediately after extubation and every five minutes after that for half hour
Started Mar 2024 (actual). Primary completion is estimated for Sep 2024, 6 months after the start.
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Studies of the drug tested here: Remimazolam besilate
University Hospital of Split