The 90% Effective Dose of Remimazolam for Duodenoscopy Insertion During ERCP
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The number of success duodenoscopy insertion
研究概览
简要总结
Remimazolam has shown promising results for sedation in colonoscopy . Alfentanil is widely used in the analgesia of ERCP . The purpose of the study was to determine the 90% Effective Dose of Remimazolam for Duodenoscopy Insertion During ERCP With Alfentanil 10µg/kg
详细描述
- Title:The 90% Effective Dose of Remimazolam for Duodenoscopy Insertion During ERCP With Alfentanil 10µg/kg 2. Research center: Single center. 3. The population of the study: Age is between 18 and 85 years; ASA I-III levels; Patients undergone elective ERCP surgery, non-intubation patients; 4. Sample size:The sample size was decided based on that of prior Literature.The study was carried out using a biased coin design up-and-down sequential method, where the dose of remimazolam administered to each patient depended on the response of the previous one with success/failure duodenoscopy insertion during ERCP are required for reliable estimates. The first patient recruited received a dose of 0.2mg/kg, based on our past experience.Subsequently, if a patient had a failure duodenoscopy insertion, the dose of remimazolam was increased by 0.025mg/kg in the next subject. If a patient had a successful duodenoscopy insertion the next subject was randomised to receive either a lower dose (with a decrement of 0.025mg/kg), with a probability of b = 0.11, or the same dose, with a probability of 1-b = 0.89.
We defined duodenoscopy insertion a failure was as gross purposeful muscular movement, coughing or vomiting occurring during or within 2 minutes of insertion of duodenoscopy. If BIS>75 and MOAA/S > 1 when 3 min after the intravenous injection of remimazolam, it was considered a failure, and the patient received rescue sedation. Success was depicted when the reactions mentioned earlier were absent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age is between 18 and 85 years
- •ASA I-III levels;
- •Patients undergone elective ERCP surgery, non-intubation patients;
排除标准
- •Chronic pain with long-term use of analgesics, psychotropic substances (including opioids, NSAIDs, sedatives, antidepressants), alcohol abusers, with known drug allergy;
- •BMI<18 or BMI>30;
- •Previous abnormal surgical anesthesia recovery history;
- •Hypertension or systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 95 mmHg when the patient admission to the operating room
- •Suffering from esophageal reflux; • Sedatives, analgesics and antipruritic drugs were used 24 hours before operation;
- •Expected difficult intubation ;
- •Opioids allergy history;
- •Take monoamine oxidase inhibitor or antidepressant within 15 days;
- •Pregnant or parturient women;
- •Involved in other drug trials within three months;
- •Patients who can not communicate well with the researcher
研究组 & 干预措施
Experimental: age<65 group
The 90% effective dose of remimazolam for duodenoscopy insertion with alfentanil 10µg/kg
干预措施: Remimazolam (Drug)
Active Comparator:age ≥65 group
The 90% effective dose of remimazolam for duodenoscopy insertion with alfentanil 10µg/kg
干预措施: Remimazolam (Drug)
结局指标
主要结局
The number of success duodenoscopy insertion
时间窗: 1 day
success duodenoscopy insertion is defined by no body movement
次要结局
- The number of the occurrence of bradycardia(1 day)
- The number of the occurrence of hypotension(1 day)
- The number of the occurrence of injection pain(1 day)
研究者
Jianbo Yu
Director
Tianjin Nankai Hospital