Effects of Sufentanil on the Intraoperative Hemodynamics

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06091904
• Collaborator: (none)
• Enrollment: 92
• Arms: 2
• Anticipated Duration (Months): 24

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intraoperative Hypotension	Drug: Sufentanil; Drug: Remifentanil	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 92 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effects of Sufentanil on the Intraoperative Hemodynamic Parameters in Patients Undergoing Extracranial-intracranial Bypass Surgery: a Prospective Randomized Controlled Trial
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Nov 1, 2024
• Anticipated Study Completion Date: Nov 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: sufentanil group sufentanil is administered for analgesic during general anesthesia	Drug: Sufentanil; Induction: sufentanil TCI 0.3 ng/ml Maintenance: sufentanil TCI 0.05-0.5 ng/ml
Active Comparator: remifentanil group remifentanil is administered for analgesic during general anesthesia	Drug: Remifentanil; Induction: remifentanil TCI 3 ng/ml Maintenance: remifentanil TCI 0.5-5 ng/ml

Outcome Measures

Primary Outcome Measures

1. Intraoperative hypotension [During surgery]

   Target systolic blood pressure < 90%

Secondary Outcome Measures

1. Inotropic requirements [During surgery]

   cumulative doses of inotropics during surgery

2. Incidence of bradycardia [During surgery]

   heart rate < 40/min

3. Incidence of tachycardia [During surgery]

   heart rate > 100/min

4. Maximum systolic blood pressure [During surgery]

   maximal systolic blood pressure

5. Minimum systolic blood pressure [During surgery]

   minimal systolic blood pressure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Principal Investigator: Chang-Hoon Koo, Seoul National University Bundang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chang-Hoon Koo, Assistant professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT06091904
• Other Study ID Numbers: Bypass-SFTN
• First Posted: Oct 19, 2023
• Last Update Posted: Oct 19, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypotension; Sufentanil; Remifentanil

Study Results

No Results Posted as of Oct 19, 2023