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RecruitingNCT06091904Updated Sep 16, 2025

Effects of Sufentanil on the Intraoperative Hemodynamics

An interventional study of Sufentanil and Remifentanil in Intraoperative Hypotension, sponsored by Seoul National University Hospital. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-09-16.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Nov 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Nov 2023; still recruiting 2 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Intraoperative Hypotension
03

In context

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
92 participants (estimated)

Study arms

  • Experimental
    sufentanil group

    sufentanil is administered for analgesic during general anesthesia

    Drug: Sufentanil

  • Active comparator
    remifentanil group

    remifentanil is administered for analgesic during general anesthesia

    Drug: Remifentanil

Interventions

  • DrugSufentanil

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

  • DrugRemifentanil

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

06

What researchers measure

Primary outcomes

  1. Intraoperative hypotension

    MAP \< 80 mmHg

    Time frame: During surgery

Secondary outcomes

  1. Inotropic requirements

    cumulative doses of inotropics during surgery

    Time frame: During surgery

  2. Incidence of bradycardia

    heart rate \< 40/min

    Time frame: During surgery

  3. Incidence of tachycardia

    heart rate \> 100/min

    Time frame: During surgery

  4. Maximum systolic blood pressure

    maximal systolic blood pressure

    Time frame: During surgery

  5. Minimum systolic blood pressure

    minimal systolic blood pressure

    Time frame: During surgery

07

Study locations

1 of 1 sites recruiting
  • Seoul National University Bundang Hospital
    Seongnam-si, Gyeonggi-do 13620, South Korea
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06091904
Lead sponsor
Seoul National University Hospital
Responsible party
Chang-Hoon Koo (Assistant professor, Seoul National University Hospital) — Principal investigator
First posted
Oct 19, 2023
Start date
Nov 24, 2023
Primary completion
Nov 1, 2025 (estimated)
Completion
Nov 1, 2026 (estimated)
Last update
Sep 16, 2025

Study contacts

Chang-Hoon Koo
Contact
vollock9@gmail.com
+821085098841
Chang-Hoon Koo
principal investigator · Seoul National University Bundang Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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