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

Sponsor

Yonsei University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05785234

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stomach Neoplasms	Drug: sufentanil-remimazolam group Drug: remifentanil-remimazolam group	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Total consumption of fentanyl in 24 hours after surgery [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul		Korea, Republic of

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT05785234

Other Study ID Numbers:

4-2022-1606

First Posted:

Mar 27, 2023

Last Update Posted:

Mar 27, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 27, 2023