Emergence Delirium, Remimazolam, Rhinoplasty
Conditions
Keywords
Remimazolam
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.
Interventions
Remimazolam 0.1 mg/kg intravenous injection
DRUGNaCl 0.9%
NaCl 0.9% 0.04 mL/kg
Sponsors
University Hospital of Split
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Richmond agitation sedation scale | Immediately after extubation and every five minutes after that for half hour |
Countries
Croatia
Contacts
Primary ContactGrgur Prižmić
Outcome results
None listed