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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-15

Study Completion Date

2026-02-01

Brief Summary

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

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Detailed Description

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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

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Emergence Agitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

80 patients scheduled for rhinoplasty will be randomly assigned to two groups. After nasal packing placement, one group will receive intraoperative 0.5 mg/kg propofol, while the other group will receive 10-minute infusion of 0.5 mcg/kg dexmedetomidine.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Dexmedetomidine (Group-D)

Group-D: Dexmedetomidine group (n:40). In rhinoplasty, 10 minute infusion of 0,5 mcg/kg dexmedetomidine will be administered after nasal packing.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

In rhinoplasty, 10 minute infusion of 0,5 mcg/kg dexmedetomidine will be administered after nasal packing

Propofol (Group-P)

Group-P: Propofol group (n:40). In rhinoplasty, 0,5 mg/kg propofol IV bolus will be administered after nasal packing.

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

In rhinoplasty, 0,5 mg/kg propofol IV bolus will be administered after nasal packing

Interventions

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Dexmedetomidine

In rhinoplasty, 10 minute infusion of 0,5 mcg/kg dexmedetomidine will be administered after nasal packing

Intervention Type DRUG

Propofol

In rhinoplasty, 0,5 mg/kg propofol IV bolus will be administered after nasal packing

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes