Effects of Sufentanil on the Intraoperative Hemodynamics

NCT ID: NCT06091904

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-24

Study Completion Date

2026-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Intraoperative Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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sufentanil group

sufentanil is administered for analgesic during general anesthesia

Group Type EXPERIMENTAL

Sufentanil

Intervention Type DRUG

Induction: sufentanil TCI 0.3 ng/ml Maintenance: sufentanil TCI 0.05-0.5 ng/ml

remifentanil group

remifentanil is administered for analgesic during general anesthesia

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

Induction: remifentanil TCI 3 ng/ml Maintenance: remifentanil TCI 0.5-5 ng/ml

Interventions

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Sufentanil

Induction: sufentanil TCI 0.3 ng/ml Maintenance: sufentanil TCI 0.05-0.5 ng/ml

Intervention Type DRUG

Remifentanil

Induction: remifentanil TCI 3 ng/ml Maintenance: remifentanil TCI 0.5-5 ng/ml

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chang-Hoon Koo

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chang-Hoon Koo

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Chang-Hoon Koo

Role: CONTACT

+821085098841

Facility Contacts

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Chang-Hoon Koo

Role: primary

Other Identifiers

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Bypass-SFTN

Identifier Type: -

Identifier Source: org_study_id

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