Actively Recruiting
Effects of Sufentanil on the Intraoperative Hemodynamic Parameters in Patients Undergoing Extracranial-intracranial Bypass Surgery: a Prospective Randomized Controlled Trial
Led by Seoul National University Hospital · Updated on 2025-09-16
92
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a randomized, controlled trial to study the effects of two different pain-relief drugs, sufentanil and remifentanil, during extracranial-intracranial bypass surgery. The study aims to compare how these drugs influence intraoperative blood pressure and heart rate during surgery. It involves adult patients undergoing this specific type of brain blood vessel surgery. Participants will be randomly assigned to one of two groups. One group receives sufentanil with an induction dose of 0.3 ng/ml and maintenance doses ranging from 0.05 to 0.5 ng/ml, while the other group receives remifentanil with an induction dose of 3 ng/ml and maintenance doses from 0.5 to 5 ng/ml. Both drugs are given during general anesthesia throughout the surgery. During the surgery, researchers will monitor blood pressure changes including episodes of low blood pressure, heart rate issues like bradycardia and tachycardia, and the need for medications to support heart function. The study tracks maximum and minimum systolic blood pressure during the operation. The entire process is overseen by Seoul National University Hospital and aims to enroll adult patients starting from age 19.
CONDITIONS
Brief Title
Effects of Sufentanil on the Intraoperative Hemodynamics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who undergo elective extracranial-intracranial bypass surgery
- American Society of Anesthesiologists grade 1,2,3
- Age > 18 years old
You will not qualify if you...
- Refuse to participate to the study
- American Society of Anesthesiologists grade 4
- Body Mass Index < 18.5 kg/m2 or > 35 kg/m2
- Allergic history of opioid
- pregnant
- MAO Inhibitor user
- Severe respiratory insufficiency
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During surgery
Participants receive sufentanil or remifentanil as analgesic during general anesthesia for extracranial-intracranial bypass surgery.
1 surgical visit
Trial Site Locations
Total: 1 location
1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Actively Recruiting
Research Team
C
Chang-Hoon Koo
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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