Actively Recruiting
Efficacy of Remifentanil in Preventing Emergence Agitation in Patients Undergoing Nasal Surgery Under Desflurane Anesthesia: A Prospective Double-blind Randomized Controlled Trial
Led by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Updated on 2024-08-06
99
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate how well remifentanil works in preventing emergence agitation compared to fentanyl and nitrous oxide in patients undergoing rhinoplasty with desflurane anesthesia. The study also examines differences in patient demographics, intraoperative and postoperative heart and blood pressure data, surgical time, and recovery scores among the different analgesia methods. This is a prospective, randomized, double-blind trial conducted to better understand pain management during nasal surgery. Participants are randomly assigned to one of three groups: Group 1 receives an intravenous infusion of remifentanil at 0.05-0.2 micrograms per kilogram per minute; Group 2 receives nitrous oxide for analgesia; Group 3 receives desflurane with oxygen and air plus an intravenous bolus of fentanyl at 1 microgram per kilogram if heart rate or blood pressure increases by 20% during surgery. These treatments are given during the operation under general anesthesia. During the study, researchers will assess agitation and sedation levels using the Richmond Agitation-Sedation Scale at 1, 5, and 15 seconds in the postoperative care unit. They will also monitor mean arterial pressure and heart rate before induction and at multiple time points after intubation. Participants will be observed for surgical and recovery data, with safety and effectiveness measures recorded throughout. The total participation period covers the surgery and immediate recovery phase.
CONDITIONS
Brief Title
Efficacy of Remifentanil in Preventing Emergence Agitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years old
- Scheduled to undergo rhinoplasty by the plastic and reconstructive surgery department
- Classified as American Society of Anesthesiologist (ASA) I or II
You will not qualify if you...
- Known allergy to remifentanil, fentanyl, or nitrous oxide
- ASA classification of III or higher
- Body mass index (BMI) greater than 35 kg/m2
- Younger than 18 years old
- Any problems preventing general anesthesia such as upper respiratory tract infection
- Declined to participate in the study
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - During surgery
Participants receive one of three analgesic interventions during nasal surgery under desflurane anesthesia: remifentanil infusion, nitrous oxide (N2O), or fentanyl bolus as needed.
1 surgical visit (in-person)
Duration - Minutes to hours post-surgery
Participants are monitored for emergence agitation and vital signs in the post-operative care unit shortly after surgery.
Single post-operative observation period
Trial Site Locations
Total: 1 location
1
Health Sciences University Gazi Yaşargil Training and Research Hospital
Diyarbakır, Kayapınar, Turkey (Türkiye), 21070
Actively Recruiting
Research Team
H
Hülya Tosun Söner
O
Osman Uzundere
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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