NCT05785234

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 27, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

1.9 years

First QC Date

February 28, 2023

Last Update Submit

March 21, 2023

Conditions

Stomach Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 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.

    after 24 hours postoperative period

Study Arms (2)

Sufentanil-remimazolam group

EXPERIMENTAL

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

Drug: sufentanil-remimazolam group

Remifentanil-remimazolam group

ACTIVE COMPARATOR

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

Drug: remifentanil-remimazolam group

Interventions

sufentanil-remimazolam groupDRUG

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.

Sufentanil-remimazolam group
remifentanil-remimazolam groupDRUG

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.

Remifentanil-remimazolam group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Scheduled for laparoscopic-assisted gastrectomy
  • American Society of Anesthesiologists(ASA) physical status I and III

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Sun Joon Bai, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sun Joon Bai, MD, PhD

CONTACT

82-2-2228-4438SJBAE@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2023

First Posted

March 27, 2023

Study Start

April 1, 2023

Primary Completion

March 1, 2025

Study Completion

June 1, 2025

Last Updated

March 27, 2023

Record last verified: 2023-03

Locations

KR(1)