The Effects of Sufentanil vs. Remifentanil in Total Intravenous Anesthesia With Remimazolam on Postoperative Pain

NCT ID: NCT05785234

Last Updated: 2023-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-30

Study Completion Date

2025-06-30

Brief Summary

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In this study, the investigators evaluate the effect of total intravenous anesthesia using sufentanil-remimazolam and remifentanil-remimazolam on postoperative pain in patients undergoing laparoscopic gastrectomy.

Detailed Description

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Conditions

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Stomach Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sufentanil-remimazolam group

The sufentanil-remimazolam group receives total intravenous anesthesia with sufentanil-remimazolam.

Group Type EXPERIMENTAL

sufentanil-remimazolam group

Intervention Type DRUG

Induction of general anesthesia with 6mg·kg-1·h-1 of remimazolam combined with 0.5 ng·ml-1 of sufentanil. Maintenance of general anesthesia with 1-2mg·kg-1·h-1 of remimazolam combined with 0.2 - 0.6 ng·ml-1 of sufentanil.

Remifentanil-remimazolam group

The remifentanil-remimazolam group receives total intravenous anesthesia with remifentanil-remimazolam.

Group Type ACTIVE_COMPARATOR

remifentanil-remimazolam group

Intervention Type DRUG

Induction of general anesthesia with 6mg·kg-1·h-1 of remimazolam combined with 4 ng·ml-1 of remifentanil. Maintenance of general anesthesia with 1-2mg·kg-1·h-1 of remimazolam combined with 2-6 ng·ml-1 of remifentanil.

Interventions

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sufentanil-remimazolam group

Induction of general anesthesia with 6mg·kg-1·h-1 of remimazolam combined with 0.5 ng·ml-1 of sufentanil. Maintenance of general anesthesia with 1-2mg·kg-1·h-1 of remimazolam combined with 0.2 - 0.6 ng·ml-1 of sufentanil.

Intervention Type DRUG

remifentanil-remimazolam group

Induction of general anesthesia with 6mg·kg-1·h-1 of remimazolam combined with 4 ng·ml-1 of remifentanil. Maintenance of general anesthesia with 1-2mg·kg-1·h-1 of remimazolam combined with 2-6 ng·ml-1 of remifentanil.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 20years or older
2. Scheduled for laparoscopic-assisted gastrectomy
3. American Society of Anesthesiologists(ASA) physical status I and III

Exclusion Criteria

1. Emergency operation
2. Patients with a history of severe hypersensitivity reaction to dextran 40
3. Patients who cannot use patient controlled analgesia(PCA)
4. Patients with morbid obesity \[body mass index (BMI) \>35 kg/m2\]
5. Patients with history of uncontrolled hypertension (diastolic BP \>110mmHg) or DM
6. Patients with history of heart failure (unstable angina, congestive heart failure)
7. Patients with history of liver failure, renal failure, allergic to medicine
8. Patients with history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia)
9. Patients with history of uncontrolled psychiatric disease (PTSD, anxiety, depression)
10. Patients with obstructive sleep apnea
11. Patients who cannot read the consent form (examples: Illiterate, foreigner)
12. Patients who withdraw the consent
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sun Joon Bai, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Locations

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Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sun Joon Bai, MD, PhD

Role: CONTACT

82-2-2228-4438

Facility Contacts

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Sun Joon Bai

Role: primary

82-2-2228-4438

Other Identifiers

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4-2022-1606

Identifier Type: -

Identifier Source: org_study_id

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