NCT07144007

Prevention of Emergence Agitation in Rhinoplasty With Subanesthetic Propofol and Single-Dose Dexmedetomidine: A Prospective Double-Blind Clinical Study

Van Yuzuncu Yil University Faculty of Medicine Ethics Committee

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Yuzuncu Yil University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

To compare of prevention of emergence agitation in rhinoplasty with subanesthetic propofol and single dose dexmedetomidine

Detailed description

The study will have a double-blind design and will be conducted after obtaining an approval from the local ethics committee. The study will include 80 patients planned for elective rhinoplasty, aged 18-65 years with an ASA score of I-II. The patients will be randomized by sealed tender and will be divided into 2 groups with 40 patients each. All cases will receive routine preparation for general anesthesia. For anesthesia induction 0,03 mg/kg midazolam, 2 mcg/kg fentanyl, 2 mg/kg propofol and 0.6 mg/kg rocuronium will be used. Anesthesia will be maintained with 60% air, 40% oxygen and 1 MAC sevoflurane. If intraoperatively needed, an additional dose of 0.5 mcg/kg fentanyl and 0.15 mg/kg rocuronium will be administered. If necessary, nicardipine infusion will be administered to provide controlled hypotension. Before the end of the surgery, 15 mg/kg paracetamol and 1 mg/kg tramadol will be administered for postoperative analgesia. After the nasal tampons are placed, one group will receive 0.5 mg/kg propofol, and the other group will receive 0.5 mcg/kg dexmedetomidine IV infusion over 10 minutes. 4 mg/kg sugammadex will be administered as a muscle relaxant reversal agent. The patient will be extubated when spontaneous breathing occurs and the patient opens their eyes with verbal stimulation. Agitation status will be assessed with the Richmond Agitation Sedation Scale (RASS) at 1 minute after extubation. Heart rate, systolic, diastolic, mean arterial pressures and saturation values will also be recorded before and after anesthesia induction, at the 5th, 10th, 15th, 20th, 25th, 30th minutes after intubation, at the 1st, 5th, 10th and 15th minutes after extubation. Additionally, if meaningless head and hand-arm movements, laryngospasm, nausea-vomiting, hypoxia (SpO2: \<85%) occur at the 1st, 5th, 10th and 15th minutes after extubation, they will be recorded. Also recovery time will be recorded. All data will be recorded and statistical analysis will be made.

Conditions

• Emergence Agitation

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	In rhinoplasty, 10 minute infusion of 0,5 mcg/kg dexmedetomidine will be administered after nasal packing
DRUG	Propofol	In rhinoplasty, 0,5 mg/kg propofol IV bolus will be administered after nasal packing

Timeline

• Start date: 2025-04-15
• Primary completion: 2026-01-01
• Completion: 2026-02-01
• First posted: 2025-08-27
• Last updated: 2025-08-27

Locations

1 site across 1 country: Turkey (Türkiye)