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Clinical trial

Effects of Sufentanil on the Intraoperative Hemodynamic Parameters in Patients Undergoing Extracranial-intracranial Bypass Surgery: a Prospective Randomized Controlled Trial

ID
Name
Bypass-SFTN
Description
This study is a randomized, controlled trial. A total of 92 patients will be randomized to receive sufentanil or remifentanil during extracranial-intracranial bypass surgery.
Trial arms
Trial start
2023-11-24
Estimated PCD
2024-11-01
Trial end
2025-11-01
Status
Recruiting
Treatment
Sufentanil
Induction: sufentanil TCI 0.3 ng/ml Maintenance: sufentanil TCI 0.05-0.5 ng/ml
Arms:
sufentanil group
Remifentanil
Induction: remifentanil TCI 3 ng/ml Maintenance: remifentanil TCI 0.5-5 ng/ml
Arms:
remifentanil group
Size
92
Primary endpoint
Intraoperative hypotension
During surgery
Eligibility criteria
Inclusion Criteria: * Patients who undergo elective extracranial-intracranial bypass surgery * American Society of Anesthesiologists grade 1,2,3 * Age \> 18 years old Exclusion Criteria: * 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 92, 'type': 'ESTIMATED'}}
Updated at
2023-11-27

1 organization

2 products

1 indication

Organization
Seoul National University Hospital
Product
Sufentanil
Indication
Hypotension
Product
Remifentanil