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NCT Number: NCT06091904

Effects of Sufentanil on the Intraoperative Hemodynamics

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.

Recruiting

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

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

Location status: Recruiting

Location contact

Chang-Hoon Koo

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sufentanil

Drug

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

Remifentanil

Drug

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

Primary outcomes

  1. Intraoperative hypotension

    Time frame: During surgery

    MAP < 80 mmHg

Secondary outcomes

  1. Inotropic requirements

    Time frame: During surgery

    cumulative doses of inotropics during surgery

  2. Incidence of bradycardia

    Time frame: During surgery

    heart rate < 40/min

  3. Incidence of tachycardia

    Time frame: During surgery

    heart rate > 100/min

  4. Maximum systolic blood pressure

    Time frame: During surgery

    maximal systolic blood pressure

  5. Minimum systolic blood pressure

    Time frame: During surgery

    minimal systolic blood pressure

Study contacts

Contact information is provided by the study sponsor or research team.

Chang-Hoon Koo

CONTACT

[email protected]

+821085098841

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 19, 2023
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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