A comparison of single dose dexmedetomidine with propofol for the prevention of emergence delirium after desflurane anaesthesia in children.
J K Makkar, N Bhatia, I Bala...
https://pubmed.ncbi.nlm.nih.gov/26444149Actively Recruiting
Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID07144007
Prevention of Emergence Agitation in Rhinoplasty With Subanesthetic Propofol and Single-Dose Dexmedetomidine: A Prospective Double-Blind Clinical Study
Led by Yuzuncu Yil University · Updated on 2025-08-27
80
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ways to prevent emergence agitation, a common complication after rhinoplasty surgery, by comparing two medications: subanesthetic propofol and a single dose of dexmedetomidine. This interventional study uses a double-blind design involving 80 patients aged 18 to 65 years who are classified as ASA I-II. The study aims to determine which medication better reduces agitation after anesthesia. Participants will be randomly assigned to one of two groups. Both groups will receive standard general anesthesia with drugs including midazolam, fentanyl, propofol, and rocuronium, along with maintenance anesthesia using sevoflurane. One group will receive a 0.5 mcg/kg dexmedetomidine infusion over 10 minutes after nasal packing, while the other group will get a 0.5 mg/kg propofol intravenous bolus at the same time. Postoperative pain relief will use paracetamol and tramadol before surgery ends, and muscle relaxation will be reversed with sugammadex. During the study, patients will be closely monitored for agitation using the Richmond Agitation Sedation Scale one minute after extubation. Heart rate, blood pressure, and oxygen saturation will be tracked at various times before, during, and after surgery. Additional observations will include any involuntary movements, laryngospasm, nausea, vomiting, or low oxygen levels after extubation. Recovery time will also be recorded. All collected data will be analyzed to compare the effects of the two medications on emergence agitation.
CONDITIONS
Brief Title
Prevention of Emergence Agitation in Rhinoplasty With Subanesthetic Propofol and Single-Dose Dexmedetomidine: A Prospective Double-Blind Clinical Study
Who Can Participate
Age: 18Years - 65Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Patients scheduled for rhinoplasty
- Between 18-65 years
- ASA I-II group
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single day (surgery day)
Participants undergo elective rhinoplasty with general anesthesia and receive either a 10-minute infusion of dexmedetomidine or a single IV bolus of propofol after nasal packing.
1 surgery visit including anesthesia and drug administration
Post-operative Follow-up
Duration - 15 minutes post-extubation
Participants are monitored for emergence agitation and vital signs for 15 minutes after extubation, including assessment of heart rate, blood pressure, oxygen saturation, and any adverse events.
Continuous monitoring during immediate recovery period
Trial Site Locations
Total: 1 location
1
Van Yüzüncü Yıl University
Van, Tuşba, Turkey (Türkiye), 65100
Actively Recruiting
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Research Team
M
Mehmet Emin Keskin, assistant professor
B
Bedrettin Bingöl, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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