Efficacy and Safety of Low-dose Esketamine Combined With Target-controlled Infusion of Propofol for Painless Gastrointestinal Endoscopy and Polypectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Cumulative propofol Consumption
研究概览
简要总结
Purpose: 1. To determine the efficacy of low-dose esketamine in painless gastrointestinal endoscopy. 2. To determine the safety of low-dose esketamine in painless gastrointestinal endoscopy. 3. To provide a theoretical basis and new ideas for the application of esketamine as a new drug in perioperative period.
详细描述
Keeping spontaneous breathing anesthesia can provide patients with comfortable diagnosis and treatment experience during gastrointestinal endoscopy, which is a vital prerequisite for the large-scale development of this operation as well as the early screening and treatment of gastrointestinal malignancies. Clinically, fentanyl combined with propofol is the most commonly used anesthesia regimen for the painless gastroscopy, however its high incidence of respiratory and circulatory depression will threaten the safety of patients. Instead, esketamine has a good action in anesthesia and analgesics, a slighter respiratory depression, as well as with a remarkable improvement in adverse effects than ketamine. What has already been proved is that low- dose of esketamine can remarkably reduce the dosage of propofol during endoscopic retrograde cholangiopancreatography; In our pilot study, we found that not only the incidence of respiratory depression was significantly lower than that of fentanyl during endoscopic polypectomy, but also the dosage of propofol was reduced at the same time,suggesting that esketamine may have a potential superiority in the painless gastrointestinal endoscopy.Our project plans to collect the patients who have received painless gastroscopy and polypectomy in the hospital, and use a target-controlled infusion (TCI) of propofol in combination with esketamine, by observing the total dose of propofol , the time of recovery and the length of hospital stay, the satisfaction of patients and endoscopists, drug side effects,adverse events of respiratory and circulatory system and other indicators ,to evaluate the efficacy and safety of this anesthetic scheme.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- 是
入选标准
- •Subject's American Society of Anesthesiologists physical status is I-III.
- •Subject has no symptoms of allergy to anesthetics.
- •Subject has no contraindications for gastrointestinal endoscopy.
- •Subject has given written informed consent to participate.
排除标准
- •Subject's BMI <18 or >30
- •Subject has poorly controlled or untreated hypertension.
- •Subject has severe ischemic heart disease.
- •Subject is an untreated or undertreated patient with hyperthyroidism.
- •Subject has used drugs that affect their central nervous system.
- •.Subject has mental illness.
- •.Subject has epilepsy.
- •.Subject has a history of chronic pain.
- •.Subject is pregnant or breast-feeding.
研究组 & 干预措施
Propofol/Esketamine sedation
Propofol target-controlled infusion is performed first,when the infusion concentration reaches 1.5μg/ml,esketamine 0.15mg/kg is injected intravenously;then the dose is adjusted according to the depth of anesthesia and the modified observer's assessment of alert /sedation scale, and propofol target-controlled infusion for every increase of 5μg/ml in concentration, the corresponding increase of esketamine is 0.05mg/kg; the total dose of esketamine used in surgery shall not exceed 0.5mg/kg.
干预措施: Propofol (Drug)
Propofol/Esketamine sedation
Propofol target-controlled infusion is performed first,when the infusion concentration reaches 1.5μg/ml,esketamine 0.15mg/kg is injected intravenously;then the dose is adjusted according to the depth of anesthesia and the modified observer's assessment of alert /sedation scale, and propofol target-controlled infusion for every increase of 5μg/ml in concentration, the corresponding increase of esketamine is 0.05mg/kg; the total dose of esketamine used in surgery shall not exceed 0.5mg/kg.
干预措施: Esketamine (Drug)
Propofol/Fentanyl sedation
Propofol target-controlled infusion is performed first.When the infusion concentration reaches 1.5μg/ml, fentanyl 0.6μg/kg is injected intravenously; then the dose is adjusted according to the depth of anesthesia and the modified observer's assessment of alert /sedation scale, and propofol target-controlled infusion for every increase of 5μg/ml in concentration,the corresponding increase of fentanyl is 0.2ug/kg; the total dose of fentanyl used in surgery shall not exceed 1.2ug/kg.
干预措施: Propofol (Drug)
Propofol/Fentanyl sedation
Propofol target-controlled infusion is performed first.When the infusion concentration reaches 1.5μg/ml, fentanyl 0.6μg/kg is injected intravenously; then the dose is adjusted according to the depth of anesthesia and the modified observer's assessment of alert /sedation scale, and propofol target-controlled infusion for every increase of 5μg/ml in concentration,the corresponding increase of fentanyl is 0.2ug/kg; the total dose of fentanyl used in surgery shall not exceed 1.2ug/kg.
干预措施: Fentanyl (Drug)
结局指标
主要结局
Cumulative propofol Consumption
时间窗: intraoperative
Total amount of propofol administered intraoperatively
次要结局
- The incidence of adverse events in pulmonary and circulatory systems(During the operation)
- The incidence of side effects of esketamine(Intraoperative)
- The number of patients'body movement during operation(During the operation)
- Time of recovery, post-anaesthesia care unit and discharge from hospital(procedure ( the end of endoscopy removal))
- The satisfaction of the endoscopist and patient(24 hours after surgery)