Preventing agitation after rhinoplasty with low-dose propofol or single-dose dexmedetomidine
Van Yuzuncu Yil University Faculty of Medicine Ethics Committee
NA · Yuzuncu Yil University · NCT07144007
This will test whether giving either a low dose of propofol or a single dose of dexmedetomidine at the end of anesthesia reduces emergence agitation in adults having elective rhinoplasty.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Yuzuncu Yil University (other) |
| Locations | 1 site (Van, Tuşba) |
| Trial ID | NCT07144007 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind study will enroll 80 adults aged 18–65 years with ASA I–II scheduled for elective rhinoplasty and assign 40 patients to a subanesthetic propofol group and 40 to a single-dose dexmedetomidine group. All patients will receive standardized general anesthesia and, after nasal tampon placement, one group will receive 0.5 mg/kg propofol while the other receives 0.5 mcg/kg dexmedetomidine infused over 10 minutes. Patients will be extubated when they breathe spontaneously and open their eyes to verbal stimulation, and agitation will be measured with the Richmond Agitation Sedation Scale one minute after extubation while vitals are monitored. The main comparison is the rate and severity of emergence agitation between the two groups.
Who should consider this trial
Good fit: Adults aged 18–65 years with ASA physical status I–II who are scheduled for elective rhinoplasty and have no significant organ disease or known allergy to the study drugs are ideal candidates.
Not a fit: Patients outside the 18–65 age range, those with ASA III or higher, significant renal/hepatic/cardiac/respiratory disease, known allergies to the medications, or not undergoing rhinoplasty are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could reduce the frequency and severity of emergence agitation after rhinoplasty, improving patient comfort and recovery safety.
How similar studies have performed: Previous studies in other surgical settings have shown that dexmedetomidine and low-dose propofol can reduce emergence agitation, but direct head-to-head evidence specifically in rhinoplasty patients is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients scheduled for rhinoplasty * Between 18-65 years * ASA I-II group Exclusion Criteria: * Those who are outside the age range of 18-65 * Those who are ASA III and above * Those with renal,hepatic, cardiac and respiratory diseases * Those with a known allergy to the medication to be used * Those who underwent urinary catheterization
Where this trial is running
Van, Tuşba
- Van Yüzüncü Yıl University — Van, Tuşba, Turkey (Türkiye) (RECRUITING)
Study contacts
- Study coordinator: Mehmet Emin Keskin, assistant professor
- Email: emin6559@hotmail.com
- Phone: +90 553 071 66 55
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.
Conditions: Emergence Agitation, emergence agitaion, Propofol, Dexmedetomidine, Rhinoplasty