A Prospective, Randomized Controlled Clinical Study of the Effect of Remimazolam on the Incidence of Hypoxia in High-risk Patients Undergoing Painless Tracheoscopy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- The incidence of hypoxia（75% ≤ SpO2 < 90% for <60 s）
研究概览
简要总结
Bronchoscopy is currently widely used for the diagnosis and treatment of various respiratory diseases. However, the operation of bronchoscopy is irritating, causes a strong stress response, and shares the airway with the patient, making the patient highly susceptible to respiratory and cardiovascular risks. Among these risks, hypoxia is the most common adverse event.Different drug regimens can be selected for anesthesia under deep sedation. The combination of analgesic agents can help reduce coughing during bronchoscopy. Therefore, we employ a combination of sedative and analgesic drugs for painless bronchoscopy procedures. Among sedatives, propofol is the most commonly used. However, due to its disadvantages, such as respiratory and circulatory depression, we have introduced a novel approach combining remimazolam for sedation. The aim is to investigate whether this new regimen, compared to traditional propofol-based sedation, can reduce the incidence of hypoxia, minimize circulatory depression, and lead to faster postoperative awakening and recovery. Additionally, we hope to observe fewer adverse events, such as perioperative nausea and vomiting, excessive secretions, dizziness, and chills.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA Class Ⅲ - Ⅳ
- •Scheduled for elective painless bronchoscopy -
排除标准
- •Age < 18 years
- •Patients who are uncooperative（e.g. due to mental illness）
- •Patients who are on chronic use of opioids, benzodiazepine - class hypnotics, or antidepressants
- •Patients with a history of allergy to the anesthetics used
- •Patients who are anticipated to have a difficult airway
- •Body mass index（BMI）<18.5kg/m² or >30kg/m²
- •Preoperative oxygen saturation <92% while breathing room air
- •Other：Patients who are deemed by the investigator to be unsuitable for participation in this trial
研究组 & 干预措施
The propofol - alfentanil group（The control group）
In this group, general anesthesia was administered using the classic propofol and alfentanil. The patients underwent fiberoptic bronchoscopy while maintaining spontaneous breathing and with a MOAA/S score of ≤2.
干预措施: propofol and alfentanil (Drug)
The remimazolam and propofol - alfentanil group (The experimental group)
This group received general anesthesia with remimazolam combined with propofol for sedation and alfentanil. Fiberoptic bronchoscopy was done while patients maintained spontaneous breathing and had a MOAA/S score of ≤2.
干预措施: remimazolam combined with propofol and alfentanil (Drug)
结局指标
主要结局
The incidence of hypoxia（75% ≤ SpO2 < 90% for <60 s）
时间窗: Periprocedural
次要结局
- The incidence of severe hypoxia（SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s）(Periprocedural)
- Non-Invasive Blood Pressure changes: The area under the curve (AUC) of the patient's mean blood pressure over time from pre-anesthesia induction to the end of bronchoscopy during patient monitoring(Periprocedural)
- The area under the curve (AUC) of the patient's mean blood pressure during observation in Post-Anesthesia Care Unit(Periprocedural)
- The dosage of vasoactive drugs administered.(Periprocedural)
研究者
Yueying Zheng
Vice Director of the Department of Anesthesiology
First Affiliated Hospital of Zhejiang University