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

March 21, 2023 updated by: Yonsei University

The Effects of Sufentanil-remimazolam vs. Remifentanil-remimazolam Total Intravenous Anesthesia on Postoperative Pain in Laparoscopic-assisted Gastrectomy - A Randomized, Controlled Study-

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sun Joon Bai, MD, PhD
  • Phone Number: 82-2-2228-4438
  • Email: SJBAE@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sufentanil-remimazolam group
The sufentanil-remimazolam group receives total intravenous anesthesia with sufentanil-remimazolam.
Drug: 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.
Active Comparator: Remifentanil-remimazolam group
The remifentanil-remimazolam group receives total intravenous anesthesia with remifentanil-remimazolam.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total consumption of fentanyl in 24 hours after surgery
Time Frame: after 24 hours postoperative period
To investigate the effect of total intravenous anesthesia with intraoperative sufentanil-remimazolam and remifentanil-remimazolam on postoperative pain, total cumulative dose of fentanyl was measured for the first postoperative 24 hour.
after 24 hours postoperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Sun Joon Bai, MD, PhD, Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

March 21, 2023

First Posted (Actual)

March 27, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2022-1606

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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