Effect and Mechanism of Remimazolam Benzenesulfonate on Enhanced Recovery After Surgery in Patients Undergoing Radical Gastrectomy for Gastric Cancer

Study Overview
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Brief Summary
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The purpose of this study is to discuss the benzene sulfonic acid red horse azole shimron the occurrence of postoperative complications in patients with gastric cancer radical and its severity, at the same time, comparing the control group (propofol) the degree of inflammation in patients with different time points difference, preliminary in this paper, the benzene sulfonic acid red horse azole shimron in gastric cancer radical viscera molecular mechanism of protection and quick recovery.

Detailed Description
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A total of 60 patients undergoing radical gastrectomy for gastric cancer were randomly divided into control group (group P) and experimental group (group R), with 30 cases in each group. Two groups are made by way of BIS target controlled infusion of anesthesia, experimental group (R group) target controlled infusion red horse azole shimron, control group (P group) target controlled infusion of propofol, BIS values are controlled in 50 + 5, postoperative observation of dynamic changes of inflammatory cytokines in plasma, postoperative adverse reactions, postoperative recovery, postoperative 30-day mortality and postoperative complications. Through statistical analysis, it is proposed that remazolam can stabilize perioperative hemodynamic fluctuation, improve postoperative recovery, reduce the release of inflammatory mediators, reduce complications, shorten the length of hospital stay, reduce hospitalization costs, and accelerate the rapid recovery of patients with radical gastrectomy. It is proved that remazolam besylate can reduce the inflammatory response of patients undergoing radical gastrectomy, reduce the incidence of postoperative complications, and provide a favorable supplement to ERAS in patients undergoing radical gastrectomy. At the same time provide more red horse azole shimron, applied to the systemic narcotic induction and maintenance of cases and further added red horse azole shimron applied to clinical usage and dosage (by age, gender, race, obesity status, ASA grade and weight the effect of covariate), adverse reactions, and other commonly used anesthetic synergy.

Official Title
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Effect and Mechanism of Remimazolam Benzenesulfonate on Eenhanced Recovery After Surgery in Patients Undergoing Radical Gastrectomy for Gastric Cancer

Conditions
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Remimazolam Benzenesulfonate on Nenhanced Recovery After Surgery, Possible Molecular Mechanism of Remimazolam Benzenesulfonate

Intervention / Treatment
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* Procedure: Remimazolam Benzenesulfonate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sixty patients undergoing elective laparoscopic radical gastrectomy for gastric cancer; aged 18-75 years; ASA≤ⅲ . - Exclusion Criteria: Emergency surgery or non-radical gastrectomy patients; age < 18 or > 75 years old, ASA grade ≥IV. Benzodiazepines or other narcotic drug allergy patients; patients with neurological and psychiatric disorders, long-term use of sedatives or antidepressants; has a history of alcoholism or drug dependence; intraoperative find distant metastasis; receive radiation and chemotherapy, cachexia; patients with a history of other malignant tumors within five years; the patient refused to participate in the study. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Sixty patients undergoing radical gastrectomy for gastric cancer were selected and divided into two groups according to random number table method: control group (group P) and experimental group (group R), with 30 cases in each group. All enrolled patients signed informed consent. Control group: the control group (group P) received target controlled infusion of propofol. Experimental group: the experimental group (group R) received target controlled infusion of remimazolam benzenesulfonate. And the BIS value of the two groups was controlled at 50±5.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group (group R)<br>The experimental group (group R) received target controlled infusion of remimazolam benzenesulfonate, and the BIS value was controlled at 50±5. | Procedure: Remimazolam Benzenesulfonate<br>* In the experimental group, remazolam 6-12mg/kg/h, atracurium cisphenylate 0.1-0.3 mg/kg and sufentanil 0.3-0.5 μg/kg were infused by micropump for anesthesia induction, and the BIS value was controlled at 50±5 before tracheal intubation. Anesthesia maintenance: intravenous infusion of remifentanil 0.1-0.3 μg/kg/min, target controlled infusion of remifentanil in experimental group (group R), BIS value was controlled at 50±5, intermittent addition of atracurium cisphenylate to maintain muscle relaxation.<br>|
| Placebo Comparator: the control group (group P)<br>the control group (group P) received target controlled infusion of propofol, and the BIS value was controlled at 50±5. | Procedure: Remimazolam Benzenesulfonate<br>* In the experimental group, remazolam 6-12mg/kg/h, atracurium cisphenylate 0.1-0.3 mg/kg and sufentanil 0.3-0.5 μg/kg were infused by micropump for anesthesia induction, and the BIS value was controlled at 50±5 before tracheal intubation. Anesthesia maintenance: intravenous infusion of remifentanil 0.1-0.3 μg/kg/min, target controlled infusion of remifentanil in experimental group (group R), BIS value was controlled at 50±5, intermittent addition of atracurium cisphenylate to maintain muscle relaxation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic changes of inflammatory cytokines in plasma | Dynamic changes of inflammatory cytokines in plasma | Before induction, 2 hours after the start of surgery, immediately after the end of surgery, 24 hours after the end of surgery, and 72 hours after the end of surgery | 
| Postoperative adverse reactions | Nausea, vomiting, respiratory depression, irritability | Within one week after surgery | 
| Postoperative recovery | Postoperative resuscitation time, tracheal intubation extubation time, catheter removal time, nasogastric tube removal time, first fluid diet time, first exhaust time, first ambulation time | Within one week after surgery | 
| Postoperative complications | pulmonary infection, oxygenation injury, arrhythmia, bleeding, intestinal paralysis, incision infection, renal insufficiency, cognitive dysfunction, etc. | Within one week after surgery | 
| mortality rate | mortality rate | Within 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remimazolam Benzenesulfonate, ERAS, Radical Gastrectomy for Gastric Cancer