Using remimazolam to prevent delirium after nasal surgeries
Remimazolam for Emergence Delirium Prevention in Patients Undergoing Rhinoseptoplasty, FESS or Septoplasty
This study is testing if the medication remimazolam can help prevent confusion after nasal surgeries in adults aged 18 to 65.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital of Split Academic / other |
| Locations | 1 site (Split) |
| Trial ID | NCT06398275 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of remimazolam in preventing emergence delirium in adult patients recovering from rhinological surgeries such as septoplasty, rhinoseptoplasty, or functional endoscopic sinus surgery. Patients aged 18-65 with ASA classification I-II will be randomized into two groups, one receiving remimazolam and the other receiving a saline solution. The primary outcome will assess the presence of delirium during recovery, while secondary outcomes will include postoperative pain levels, recovery room stay duration, and mood changes. The study will provide insights into the safety and efficacy of remimazolam in this specific surgical context.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 scheduled for rhinoplasty, rhinoseptoplasty, or functional endoscopic sinus surgery with ASA classification I or II.
Not a fit: Patients who are pregnant or have been treated with psychiatric medication within six months prior to the operation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of emergence delirium in patients undergoing nasal surgeries.
How similar studies have performed: Other studies have shown promising results with remimazolam in similar contexts, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Split
- UH Split — Split, Croatia (Recruiting)
Study contacts
- Study coordinator: Grgur Prižmić
- Email: gregorio.prizmic@gmail.com
- Phone: +385994213808
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.