Safety and Efficacy of Remazolam in Gastroenteroscopy in Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- induction time
研究概览
简要总结
Studies have shown that etomidate combined with propofol in gastroscopy has high safety and lower incidence of hypoxia and hypotension, suggesting the advantages of etomidate combined with propofol in elderly patients.
Remimazolam Besylate is a 1.1 class new drug that acts on GABA receptors and is metabolized by plasma esterase with fast metabolism time, only 1/7 of midazolam, which may be more suitable for elderly patients. Therefore, this study intends to explore the safety and effectiveness of two sedation schemes in gastroenteroscopy for elderly patients.
详细描述
Before starting the endoscopy procedures, patients were randomly assigned to either Remimazolam Besylate group or propofol combined with etomidate group. The onset time, recovery time, vital signs, postoperative recovery, cognitive function and adverse events were compared.
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
- Triple (Participant, 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
- •Patients with asAI-II indications for painless gastroenteroscopy and receiving diagnostic or therapeutic gastroenteroscopy;
- •Aged 60-75, body mass index (BMI) 19-28 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 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;
研究组 & 干预措施
Remimazolam group
Patients received remimazolam to maintain sufficient sedation (sufficient sedation as judged by MOAA/S ≤ 4 for 3 consecutive measurements) during endoscopy procedure. And patients were injected remifentanil 0.3μg/kg (infusion time > 1min) at the first time，When the analgesia was insufficient, Remifentanil can be added according to the situation.
干预措施: Remimazolam Besylate (Drug)
EP group
Patients received Etomidate combined with propofol to maintain sufficient sedation (sufficient sedation as judged by MOAA/S ≤ 4 for 3 consecutive measurements) during endoscopy procedure. And patients were injected remifentanil 0.3μg/kg (infusion time > 1min) at the first time.When the analgesia was insufficient,Remifentanil can be added according to the situation
干预措施: etomidate combined with propofol (Drug)
结局指标
主要结局
induction time
时间窗: day 0
The time from the beginning of the drug injection to the time when the patient does not respond to the verbal call
Recovery time
时间窗: day 0
First of 3 consecutive MOAA/S scores of 5 after the last injection of study drug
Modified Observer's Assessment of Alertness/Sedation[MOAA/S]
时间窗: day 0
MOAA/S score ranges from 0 to 5 points, 0 point means patients do not respond to noxious stimulation; 5 point means patients responds readily to name spoken in normal tone. When the Modified Observer's Assessment of Alertness/ Sedation \[MOAA/S\] ≤4 that patients are sufficiently sedated.
Observation time in the PACU
时间窗: day 0
the time interval between "endoscope removal" and "departure from the recovery room" （PADS score≥9）
次要结局
- Simple Intelligence Assessment Scale (mini-cog)(Every 4 hours, up to 1 week)
- Drug dosages(day 0)
- Patient overall satisfaction and surgeon satisfaction score(day 0)
- Respiration rate[RR](day 0)
- End-tidal carbon dioxide [EtCO2](day 0)
- Visual analogue scale (VAS)(day 0)
- Level of hypoxia(day 0)
- Respiratory depression(day 0)
- Assessment of pulse oximetry measurements[SpO2](day 0)
- Rate of nause、vomiting、 dizziness、hiccups、 cough choking 、body movement(Within 24 hours)
- Supine heart rate[HR](day 0)
- Systolic, diastolic, blood pressure(day 0)
研究者
Yi Feng, MD
Chief of Anesthesiology department
Peking University People's Hospital