NCT06398275

Remimazolam for Emergence Delirium Prevention in Patients Undergoing Rhinoseptoplasty, FESS or Septoplasty

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University Hospital of Split · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Remimazolam
• Emergence Delirium
• Rhinoplasty

Interventions

Type	Name	Description
DRUG	Remimazolam 20 MG Injection [Byfavo]	Remimazolam 0.1 mg/kg intravenous injection
DRUG	NaCl 0.9%	NaCl 0.9% 0.04 mL/kg

Timeline

• Start date: 2024-03-06
• Primary completion: 2024-09-01
• Completion: 2024-12-01
• First posted: 2024-05-03
• Last updated: 2024-05-03

Locations

1 site across 1 country: Croatia