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Trial Title:
The Effects of Sufentanil vs. Remifentanil in Total Intravenous Anesthesia With Remimazolam on Postoperative Pain
NCT ID:
NCT05785234
Condition:
Stomach Neoplasms
Conditions: Official terms:
Stomach Neoplasms
Pain, Postoperative
Sufentanil
Remifentanil
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
sufentanil-remimazolam group
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.
Arm group label:
Sufentanil-remimazolam group
Intervention type:
Drug
Intervention name:
remifentanil-remimazolam group
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.
Arm group label:
Remifentanil-remimazolam group
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Sun Joon Bai
Phone:
82-2-2228-4438
Email:
SJBAE@yuhs.ac
Start date:
April 2023
Completion date:
June 2025
Lead sponsor:
Agency:
Yonsei University
Agency class:
Other
Source:
Yonsei University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05785234
