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Effects of Sufentanil on the Intraoperative Hemodynamics

ConditionIntraoperative Hypotension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSeoul National University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who undergo elective extracranial-intracranial bypass surgery

American Society of Anesthesiologists grade 1,2,3

Age > 18 years old

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

92 Participants
are divided into 2 treatment groups
Group A: sufentanil groupExperimental treatment 1 intervention
Group B: remifentanil groupActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Hospital

Lead sponsor

Source ClinicalTrials.gov
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