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NCT06091904 Clinical Trial

Effects of Sufentanil on the Intraoperative Hemodynamics

Intraoperative Hypotension Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06091904
Other study ID # Bypass-SFTN
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 24, 2023
Est. completion date November 1, 2025

Study information
Verified date November 2023
Source Seoul National University Hospital
Contact Chang-Hoon Koo
Phone +821085098841
Email vollock9@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 92
Est. completion date November 1, 2025
Est. primary completion date November 1, 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Sufentanil
Induction: sufentanil TCI 0.3 ng/ml Maintenance: sufentanil TCI 0.05-0.5 ng/ml
• Remifentanil
Induction: remifentanil TCI 3 ng/ml Maintenance: remifentanil TCI 0.5-5 ng/ml

Locations
Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intraoperative hypotension Target systolic blood pressure < 90% During surgery
Secondary Inotropic requirements cumulative doses of inotropics during surgery During surgery
Secondary Incidence of bradycardia heart rate < 40/min During surgery
Secondary Incidence of tachycardia heart rate > 100/min During surgery
Secondary Maximum systolic blood pressure maximal systolic blood pressure During surgery
Secondary Minimum systolic blood pressure minimal systolic blood pressure During surgery
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