Clinical trial NCT05559151: Effect and Mechanism of Remimazolam Benzenesulfonate on Enhanced Recovery After Surgery in Patients Undergoing Radical Gastrectomy for Gastric Cancer
Official title: Effect and Mechanism of Remimazolam Benzenesulfonate on Eenhanced Recovery After Surgery in Patients Undergoing Radical Gastrectomy for Gastric Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Remimazolam Benzenesulfonate on Nenhanced Recovery After Surgery
Possible Molecular Mechanism of Remimazolam Benzenesulfonate
Keywords: Remimazolam Benzenesulfonate
ERAS
Radical Gastrectomy for Gastric Cancer
Lead sponsor: Shaoxing Hospital of Zhejiang University
Sponsor class: OTHER
Collaborators: name: China (Zhejiang) Health technology RESEARCH and development and transformation platform
First posted: 2022-09-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria: Sixty patients undergoing elective laparoscopic radical gastrectomy for gastric cancer; aged 18-75 years; ASA≤ⅲ .

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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.

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Primary outcomes:
measure: Dynamic changes of inflammatory cytokines in plasma
timeFrame: 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
measure: Postoperative adverse reactions
timeFrame: Within one week after surgery
measure: Postoperative recovery
timeFrame: Within one week after surgery
measure: Postoperative complications
timeFrame: Within one week after surgery
measure: mortality rate
timeFrame: Within 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shaoxing
country: China
facility: Shaoxing People's Hospital
state: Zhejiang
Study officials:
References: