Effect and Mechanism of Remimazolam Benzenesulfonate on Eenhanced Recovery After Surgery in Patients Undergoing Radical Gastrectomy for Gastric Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative adverse reactions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Neither the experimenters nor the participants knew whether they were getting an experimental drug or a placebo. In this way, the description of the therapeutic effects and adverse reactions of the subjects, as well as the record of the various reactions of the experimenters, can be as objective as possible.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sixty patients undergoing elective laparoscopic radical gastrectomy for gastric cancer; aged 18-75 years; ASA≤ⅲ .
排除标准
- •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.
研究组 & 干预措施
experimental group (group R)
The experimental group (group R) received target controlled infusion of remimazolam benzenesulfonate, and the BIS value was controlled at 50±5.
干预措施: Remimazolam Benzenesulfonate (Procedure)
the control group (group P)
the control group (group P) received target controlled infusion of propofol, and the BIS value was controlled at 50±5.
干预措施: Remimazolam Benzenesulfonate (Procedure)
结局指标
主要结局
Postoperative adverse reactions
时间窗: Within one week after surgery
Nausea, vomiting, respiratory depression, irritability
Postoperative complications
时间窗: Within one week after surgery
pulmonary infection, oxygenation injury, arrhythmia, bleeding, intestinal paralysis, incision infection, renal insufficiency, cognitive dysfunction, etc.
Dynamic changes of inflammatory cytokines in plasma
时间窗: 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
Dynamic changes of inflammatory cytokines in plasma
Postoperative recovery
时间窗: Within one week after surgery
Postoperative resuscitation time, tracheal intubation extubation time, catheter removal time, nasogastric tube removal time, first fluid diet time, first exhaust time, first ambulation time
mortality rate
时间窗: Within 30 days after surgery
mortality rate
次要结局
未报告次要终点
研究者
Zhonghua Chen,MD
associate chief physician
Shaoxing Hospital of Zhejiang University