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

Stomach Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05785234
• Other study ID #: 4-2022-1606
• Status: Recruiting
• Phase: N/A
• Start date: April 2023
• Est. completion date: June 2025

Study information

• Verified date: March 2023
• Source: Yonsei University
• Contact: Sun Joon Bai, MD, PhD
• Phone: 82-2-2228-4438
• Email: SJBAE[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: June 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Stomach Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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