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

University Hospital of Split

Status and phase: Enrolling; Phase 2

Conditions: Remimazolam; Emergence Delirium; Rhinoplasty

Treatments: Drug: Remimazolam 20 MG Injection [Byfavo]; Drug: NaCl 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT06398275

520-03/24-01/14

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

80 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Remimazolam 20 MG Injection [Byfavo]

2

Placebo Comparator group

Treatment:

Drug: NaCl 0.9%