An interventional study of Dexmedetomidine and Propofol in Emergence Agitation, sponsored by Yuzuncu Yil University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-27.
Sponsored by Yuzuncu Yil University · Not applicable, Interventional, and Prevention
To compare of prevention of emergence agitation in rhinoplasty with subanesthetic propofol and single dose dexmedetomidine
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.
763 studies on the registry are indexed under Emergence Delirium; 241 are open to participants now.
This study's planned enrollment of 80 is below the median of 120 across 475 interventional studies indexed under Emergence Delirium.
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Exclusion Criteria:
Group-D: Dexmedetomidine group (n:40). In rhinoplasty, 10 minute infusion of 0,5 mcg/kg dexmedetomidine will be administered after nasal packing.
Drug: Dexmedetomidine
Group-P: Propofol group (n:40). In rhinoplasty, 0,5 mg/kg propofol IV bolus will be administered after nasal packing.
Drug: Propofol
In rhinoplasty, 10 minute infusion of 0,5 mcg/kg dexmedetomidine will be administered after nasal packing
In rhinoplasty, 0,5 mg/kg propofol IV bolus will be administered after nasal packing
Agitation status
The effect on prevention of emergence agitation of propofol and dexmedetomidine will be evaluated by an anaesthetist with the Richmond Agitation Sedation Scale (RASS) at 1 minute after extubation
Time frame: 1. minute after extubation
Heart rate
Heart rate will be measured pre-induction of anesthesia, post-induction of anesthesia, 5th, 10th, 15th minutes after intubation, during extubation, 1st, 5th, 10th, 15th minutes after extubation
Time frame: perioperatively defined times
Blood Pressure
Systolic blood pressure, diastolic blood preesuure, mean arterial pressure will be measured pre-induction of anesthesia, post-induction of anesthesia, 1st, 5th, 10th, 15th minutes after intubation, during extubation, 5th, 10th, 15th minutes after extubation
Time frame: perioperatively defined times
oxygen saturation
Oxygen saturation will be measured pre-induction of anesthesia, post-induction of anesthesia, 5th, 10th, 15th minutes after intubation, during extubation, 1st, 5th, 10th, 15th minutes after extubation
Time frame: perioperatively defined times
Plan to share: Yes — Study protocol anda statistical analysis plan will be share with other researchers
Supporting information: Study protocol, Sap
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Yuzuncu Yil University