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

Study 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.

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

Conditions
-----------------
Stomach Neoplasms

Intervention / Treatment
-----------------
* Drug: sufentanil-remimazolam group
* Drug: remifentanil-remimazolam group


Participation Criteria
=================
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 Patients who cannot read the consent form (examples: Illiterate, foreigner) Patients who withdraw the consent

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sufentanil-remimazolam group<br>The sufentanil-remimazolam group receives total intravenous anesthesia with sufentanil-remimazolam. | Drug: sufentanil-remimazolam group<br>* 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.<br>|
| Active Comparator: Remifentanil-remimazolam group<br>The remifentanil-remimazolam group receives total intravenous anesthesia with remifentanil-remimazolam. | Drug: remifentanil-remimazolam group<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |