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

Primary Purpose

Stomach Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
sufentanil-remimazolam group
remifentanil-remimazolam group
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stomach Neoplasms

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 20years or older Scheduled for laparoscopic-assisted gastrectomy American Society of Anesthesiologists(ASA) physical status I and III Exclusion Criteria: Emergency operation Patients with a history of severe hypersensitivity reaction to dextran 40 Patients who cannot use patient controlled analgesia(PCA) Patients with morbid obesity [body mass index (BMI) >35 kg/m2] Patients with history of uncontrolled hypertension (diastolic BP >110mmHg) or DM Patients with history of heart failure (unstable angina, congestive heart failure) Patients with history of liver failure, renal failure, allergic to medicine Patients with history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia) Patients with history of uncontrolled psychiatric disease (PTSD, anxiety, depression) Patients with obstructive sleep apnea Patients who cannot read the consent form (examples: Illiterate, foreigner) Patients who withdraw the consent

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sufentanil-remimazolam group

Remifentanil-remimazolam group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Total consumption of fentanyl in 24 hours after surgery
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.

Secondary Outcome Measures

Full Information

First Posted
February 28, 2023
Last Updated
March 21, 2023
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT05785234
Brief Title
The Effects of Sufentanil vs. Remifentanil in Total Intravenous Anesthesia With Remimazolam on Postoperative Pain
Official Title
The Effects of Sufentanil-remimazolam vs. Remifentanil-remimazolam Total Intravenous Anesthesia on Postoperative Pain in Laparoscopic-assisted Gastrectomy - A Randomized, Controlled Study-
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sufentanil-remimazolam group
Arm Type
Experimental
Arm Description
The sufentanil-remimazolam group receives total intravenous anesthesia with sufentanil-remimazolam.
Arm Title
Remifentanil-remimazolam group
Arm Type
Active Comparator
Arm Description
The remifentanil-remimazolam group receives total intravenous anesthesia with remifentanil-remimazolam.
Intervention Type
Drug
Intervention Name(s)
sufentanil-remimazolam group
Intervention Description
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
Intervention Name(s)
remifentanil-remimazolam group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total consumption of fentanyl in 24 hours after surgery
Description
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.
Time Frame
after 24 hours postoperative period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 20years or older Scheduled for laparoscopic-assisted gastrectomy American Society of Anesthesiologists(ASA) physical status I and III Exclusion Criteria: Emergency operation Patients with a history of severe hypersensitivity reaction to dextran 40 Patients who cannot use patient controlled analgesia(PCA) Patients with morbid obesity [body mass index (BMI) >35 kg/m2] Patients with history of uncontrolled hypertension (diastolic BP >110mmHg) or DM Patients with history of heart failure (unstable angina, congestive heart failure) Patients with history of liver failure, renal failure, allergic to medicine Patients with history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia) Patients with history of uncontrolled psychiatric disease (PTSD, anxiety, depression) Patients with obstructive sleep apnea Patients who cannot read the consent form (examples: Illiterate, foreigner) Patients who withdraw the consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sun Joon Bai, MD, PhD
Phone
82-2-2228-4438
Email
SJBAE@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun Joon Bai, MD, PhD
Organizational Affiliation
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun Joon Bai
Phone
82-2-2228-4438
Email
SJBAE@yuhs.ac

12. IPD Sharing Statement

Learn more about this trial

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

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