Effects of Sufentanil on the Intraoperative Hemodynamics | NCT06091904

Studies
Effects of Sufentanil on the Intraoperative Hemodynamics

NCT06091904

Sponsor

Seoul National University Hospital

Status

Recruiting

Last Update Posted

Sep 16, 2025Actual

Enrollment

92Estimated

Phase

Not Applicable

Conditions

Intraoperative Hypotension

Interventions

Sufentanil
Remifentanil

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 24, 2023Actual

Primary Completion Date

Nov 1, 2025Estimated

Completion Date

Nov 1, 2026Estimated

First Submitted Date

Oct 13, 2023

First Submission Date that Met QC Criteria

Oct 13, 2023

First Posted Date

Oct 19, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2025

Last Update Posted Date

Sep 16, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chang-Hoon Koo, Assistant professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

92Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sufentanil group	Experimental	sufentanil is administered for analgesic during general anesthesia	Drug: Sufentanil
remifentanil group	Active Comparator	remifentanil is administered for analgesic during general anesthesia	Drug: Remifentanil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sufentanil	Drug	Induction: sufentanil TCI 0.3 ng/ml Maintenance: sufentanil TCI 0.05-0.5 ng/ml	sufentanil group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Inotropic requirements	cumulative doses of inotropics during surgery	During surgery
Incidence of bradycardia	heart rate < 40/min

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chang-Hoon Koo	Contact	+821085098841		vollock9@gmail.com

Overall Officials

Name	Affiliation	Role
Chang-Hoon Koo	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital	Recruiting	Seongnam-si	Gyeonggi-do	13620	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017409	Sufentanil
D000077208	Remifentanil

Ancestor Terms

ID	Term
D005283	Fentanyl
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

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Browse Branches

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