The Safety and Effectiveness of Remimazolam Tosilate Versus Midazolam in Elderly Patients Undergoing Gastrointestinal Endoscopy: A Multicenter ,Prospective, Double-Blinded, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 353
- 试验地点
- 1
- 主要终点
- Recovery time after operation
研究概览
简要总结
Midazolam is a commonly used drug in gastrointestinal endoscopy due to the good cardiovascular stability and mild respiratory depression for elderly patients. However, there is the concern about the the longer and less predictable recovery or the potential for repeat sedation when the active metabolite becomes bioavailable. Remimazolam Tosilate is an innovative benzodiazepine with better sedation effect and less recovery or resedation issues than midazolam, which possibly make the drug more suitable in elderly patients. We aim to clarify whether remimazolam tosilate is better than midazolam in elderly patients undergoing gastrointestinal endoscopy.
详细描述
Before starting the endoscopy procedures, patients were randomized to receive remimazolam tosilate or midazolam to maintain sufficient sedation, then remifentanil was slowly injected for patients' sufficient analgesia during the examination. We aim to use patients' recovery time, cognition function and other measurement scales to clarify whether remimazolam tosilate is better than midazolam in elderly patients undergoing gastrointestinal endoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo a routine diagnostic or therapeutic gastrointestinal endoscopy ;
- •Age 60 to 75 ;
- •ASA physical status score of I, II or III;
- •A body mass index (BMI) of 19 to 28 kg/m2;
- •Systolic blood pressure of 90-140mmHg, diastolic blood pressure of 50-90mmHg, resting heart rate of 50-100bpm and blood pulse oxygen saturation ≥95%
排除标准
- •Those who are refused to be included;
- •Those who are allergic to the drugs used in this study;
- •Epilepsy and other mental illnesses, a history of addiction such as opiates and other analgesics and/or tranquilizers (hypnotics);
- •Severe cardiac dysfunction: NYHA cardiac functions grade 3-4, a history of recent myocardial infarction or cerebral infarction, severe conduction block or malignant arrhythmia;
- •Renal failure or liver cirrhosis;
- •Severe lung infection or upper respiratory tract infection;
- •Sleep apnea syndrome, difficult airway (Mallampati score of 3 or 4) or asthma status;
- •Advanced cancer accompanied by extensive intra-abdominal metastasis, acute and chronic obstruction of the gastrointestinal tract, bleeding and severe abdominal effusion;
研究组 & 干预措施
Remimazolam Tosilate group
Patients received remimazolam tosilate to maintain sufficient sedation (sufficient sedation as judged by MOAA/S ≤ 4 for 3 consecutive measurements) during endoscopy procedure. And patients were slowly injected of 0.4 ug/kg of remifentanil for 1 min during the examination.When the analgesia was insufficient, Remifentanil can be added 5-10 ug each time according to the situation.
干预措施: remimazolam tosilate group (Drug)
Midazolam group
Patients received midazolam to maintain sufficient sedation (sufficient sedation as judged by MOAA/S ≤ 4 for 3 consecutive measurements) during endoscopy procedure. And patients were slowly injected of 0.4 ug/kg of remifentanil for 1 min during the examination.When the analgesia was insufficient, Remifentanil can be added 5-10 ug each time according to the situation.
干预措施: Midazolam group (Drug)
结局指标
主要结局
Recovery time after operation
时间窗: Day 0
First of 3 consecutive MOAA/S scores of 5 after the last injection of study drug.
次要结局
- Supine heart rate[HR](Day 0)
- Modified Observer's Assessment of Alertness/Sedation[MOAA/S](Day 0)
- Visual analogue scale (VAS)(Day 0)
- Post-anesthesia discharge score (PADS)(Record within 2 hours ，no more than 6 hours)
- Perioperative anesthesia effect(Day 0)
- Drug dosages(Day 0)
- Simple Intelligence Assessment Scale (mini-cog)(Every 4 hours, up to 1 week.)
- Patient overall satisfaction and surgeon satisfaction score(Day 0)
- Systolic, diastolic, and mean blood pressure [MBP](Day 0)
- Respiratory depression(Within 24 hours)
- Abdominal pain and nausea(Within 24 hours)
- Assessment of pulse oximetry measurements[SpO2](Day 0)
- Respiration rate[RR](Day 0)
- End-tidal carbon dioxide [EtCO2](Day 0)
- Rate of coughing and vomiting(Within 24 hours)
- Level of hypoxia(Within 24 hours)
研究者
Yi Feng, MD
Chief of Anesthesiology department
Peking University People's Hospital