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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Patients scheduled for rhinoplasty, rhinoseptoplasty or FESS

• ASA I or II

Locations
Other Locations
Croatia
UH Split
RECRUITING
Split
Contact Information
Primary
Grgur Prižmić
gregorio.prizmic@gmail.com
+385994213808
Time Frame
Start Date: 2024-03-06
Estimated Completion Date: 2024-12
Participants
Target number of participants: 80
Treatments
Experimental: 1
Placebo_comparator: 2
Related Therapeutic Areas
Sponsors
Leads: University Hospital of Split

This content was sourced from clinicaltrials.gov