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Clinical Trials/NCT05785234
NCT05785234
Recruiting
Not Applicable

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

Yonsei University1 site in 1 country66 target enrollmentApril 2023

Overview

Phase
Not Applicable
Intervention
sufentanil-remimazolam group
Conditions
Stomach Neoplasms
Sponsor
Yonsei University
Enrollment
66
Locations
1
Primary Endpoint
Total consumption of fentanyl in 24 hours after surgery
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2023
End Date
June 2025
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

Sufentanil-remimazolam group

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

Intervention: sufentanil-remimazolam group

Remifentanil-remimazolam group

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

Intervention: remifentanil-remimazolam group

Outcomes

Primary Outcomes

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.

Study Sites (1)

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