NCT06091904

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Nov 2023Nov 2026

First Submitted

Initial submission to the registry

October 13, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 19, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

November 24, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

1.9 years

First QC Date

October 13, 2023

Last Update Submit

September 10, 2025

Conditions

Intraoperative Hypotension

Outcome Measures

Primary Outcomes (1)

  • Intraoperative hypotension

    MAP \< 80 mmHg

    During surgery

Secondary Outcomes (5)

  • Inotropic requirements

    During surgery

  • Incidence of bradycardia

    During surgery

  • Incidence of tachycardia

    During surgery

  • Maximum systolic blood pressure

    During surgery

  • Minimum systolic blood pressure

    During surgery

Study Arms (2)

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

SufentanilDRUG

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

sufentanil group
RemifentanilDRUG

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

remifentanil group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who undergo elective extracranial-intracranial bypass surgery
  • American Society of Anesthesiologists grade 1,2,3
  • Age \> 18 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

MeSH Terms

Interventions

SufentanilRemifentanil

Intervention Hierarchy (Ancestors)

FentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPropionatesAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Chang-Hoon Koo

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chang-Hoon Koo

CONTACT

+821085098841vollock9@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

October 13, 2023

First Posted

October 19, 2023

Study Start

November 24, 2023

Primary Completion

November 1, 2025

Study Completion (Estimated)

November 1, 2026

Last Updated

September 16, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)