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

Phase 2

Recruiting

• Conditions: Remimazolam; Emergence Delirium; Rhinoplasty
• Interventions: Drug: Remimazolam 20 MG Injection [Byfavo]; Drug: NaCl 0.9%

• Registration Number: NCT06398275
• Lead Sponsor: University Hospital of Split

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-03-06
• Study First Submitted: 2024-04-29
• Study First Submitted QC: 2024-05-02
• Last Update Submitted: 2024-05-02
• Study First Posted: 2024-05-03
• Last Update Posted: 2024-05-03
• Primary Completion: 2024-09
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients scheduled for rhinoplasty, rhinoseptoplasty or FESS
• ASA I or II

Exclusion Criteria

• pregnancy
• patients treated with psychiatric medication (in the time of operation or 6 months prior to operation)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Remimazolam 20 MG Injection [Byfavo]	-
2	NaCl 0.9%	-

Primary Outcome Measures

Name	Time	Method
Richmond agitation sedation scale	Immediately after extubation and every five minutes after that for half hour

Trial Locations

Locations (1)

UH Split; 🇭🇷 Split, Croatia