Effects of Sufentanil on the Intraoperative Hemodynamics

September 10, 2025 updated by: Chang-Hoon Koo, Seoul National University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sufentanil group
sufentanil is administered for analgesic during general anesthesia
Drug: Sufentanil
Induction: sufentanil TCI 0.3 ng/ml Maintenance: sufentanil TCI 0.05-0.5 ng/ml
Active Comparator: remifentanil group
remifentanil is administered for analgesic during general anesthesia
Drug: Remifentanil
Induction: remifentanil TCI 3 ng/ml Maintenance: remifentanil TCI 0.5-5 ng/ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative hypotension
Time Frame: During surgery
MAP < 80 mmHg
During surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inotropic requirements
Time Frame: During surgery
cumulative doses of inotropics during surgery
During surgery
Incidence of bradycardia
Time Frame: During surgery
heart rate < 40/min
During surgery
Incidence of tachycardia
Time Frame: During surgery
heart rate > 100/min
During surgery
Maximum systolic blood pressure
Time Frame: During surgery
maximal systolic blood pressure
During surgery
Minimum systolic blood pressure
Time Frame: During surgery
minimal systolic blood pressure
During surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Chang-Hoon Koo, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2023

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

October 13, 2023

First Submitted That Met QC Criteria

October 13, 2023

First Posted (Actual)

October 19, 2023

Study Record Updates

Last Update Posted (Estimated)

September 16, 2025

Last Update Submitted That Met QC Criteria

September 10, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bypass-SFTN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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