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Effects of Sufentanil on the Intraoperative Hemodynamics

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06091904
Enrollment
92
Registered
2023-10-19
Start date
2023-11-24
Completion date
2026-11-01
Last updated
2025-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraoperative Hypotension

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.

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

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Intraoperative hypotensionDuring surgeryMAP \< 80 mmHg

Secondary

MeasureTime frameDescription
Inotropic requirementsDuring surgerycumulative doses of inotropics during surgery
Incidence of bradycardiaDuring surgeryheart rate \< 40/min
Incidence of tachycardiaDuring surgeryheart rate \> 100/min
Maximum systolic blood pressureDuring surgerymaximal systolic blood pressure
Minimum systolic blood pressureDuring surgeryminimal systolic blood pressure

Countries

South Korea

Contacts

Primary ContactChang-Hoon Koo
vollock9@gmail.com+821085098841

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026