Total Intravenous Anesthesia for Rigid Bronchoscopy - Remimazolam Versus Propofol: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 60
- 主要终点
- The duration of emergence after rigid bronchoscopy
研究概览
简要总结
Rigid bronchoscopy usually requires deep general anesthesia, but the duration of the procedure is relatively short. Remimazolam, a recently developed anesthetics, showed faster recovery from anesthesia and stable hemodynamics compared to propofol, the most popular anesthetics. However, few studies have investigated the usefulness of remimazolam for rigid bronchoscopy. Therefore, the investigators compared the usefulness of propofol and remimazolam in total intravenous anesthesia for rigid bronchoscopy.
详细描述
Rigid bronchoscopy usually requires deep general anesthesia, but the duration of the procedure is relatively short. Therefore, anesthesiologists need anesthetics that simultaneously provide hemodynamical stability and faster recovery from anesthesia. Remimazolam showed faster recovery from anesthesia and stable hemodynamic profiles compared to propofol, the most popular anesthetics during general anesthesia. However, few studies have investigated the usefulness of remimazolam during rigid bronchoscopy. In this randomized controlled trial, the investigators want to compare the recovery duration from anesthesia after a rigid bronchoscopy procedure between patients undergoing intravenous anesthesia using remimazolam and propofol.
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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients who undergoing rigid bronchoscopy under general anesthesia in Samsung Medical Center, Seoul, South Korea
- •American Society of Anesthesiologists physical status I, II, III
排除标准
- •patients who are contraindicated in benzodiazepine (e,g., allergy to the drug or have a history of hypersensitivity reactions)
- •drug or alcohol addiction
- •neuromuscular disease or mental illness
- •metabolic disease
- •emergency surgery
- •body mass index >30 kg/m2 or <18.5 kg/m2
- •patient's refusal
- •patients in shock or coma
- •Patients contraindicated to remimazolam such as acute narrow-angle glaucoma, sleep apnea, severe or acute respiratory failure, galactose intolerance, lactase deficiency, glucose-galactose malabsorption, severe hypersensitivity to dextran 40.
研究组 & 干预措施
Remimazolam besylate
Remimazolam group receive total intravenous anesthesia using remimazolam besylate and remifentanil during rigid bronchoscopy. Remimazolam group receive flumazenil during the emergence from anesthesia.
干预措施: Remimazolam besylate (Drug)
Propofol
Propofol group receive total intravenous anesthesia using propofol and remifentanil during rigid bronchoscopy.
干预措施: Propofol (Drug)
结局指标
主要结局
The duration of emergence after rigid bronchoscopy
时间窗: From the end of anesthetics infusion to the extubation, an average of 10 minutes
The time interval between the end of anesthetics infusion and the extubation
次要结局
- The duration of induction before rigid bronchoscopy(From the start of anesthetics infusion to the loss of responsiveness, an average of 5 minutes)
- Use of vasoactive medication during rigid bronchoscopy(From the start of anesthetics infusion to the extubation, an average of 30 minutes)
- Awareness during general anesthesia(From the start of anesthetics infusion to the extubation, an average of 30 minutes)
研究者
Hyun Joo Ahn
Professor, Medical Doctor
Samsung Medical Center