Discharge Readiness After Propofol With or Without Esketamine for Outpatient Flexible Bronchoscopy: a Randomized, Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 246
- 试验地点
- 1
- 主要终点
- Proportions of patients discharged within 30 min after bronchoscopy
研究概览
简要总结
Bronchoscopy is a promising technology for lung and bronchus disease detection and therapy. However, this procedure is associated with a relatively high risk of hypoxemia, coughing, wheezing, and dyspnea. Despite the fact that propofol is the most commonly used agent in procedure sedation, the narrow therapeutic index remains challenging. Esketamine is the s-enantiomer of ketamine with potent analgesic and sedative properties. This study aims to test the hypothesis that adding subanesthetic esketamine to propofol is non-inferior to propofol alone for bronchoscopy on the recovery profile and discharge from the hospital.
详细描述
Bronchoscopy is one of the most common procedures to detect lung and bronchus disease. The procedure is generally uncomfortable and associated with a relatively high risk of hypoxemia, coughing, wheezing, and dyspnea. Therefore, physicians are placing increasing importance on the use of procedure sedation due to the demand for comfortable medical care.
Propofol is an effective agent for sedation in bronchoscopy with rapid onset and recovery. However, the safety endpoints of propofol are not cost-effective, including injection pain, hypotension, apnea, airway compromise, and without a reversal agent. Specifically, the depressive effects on the respiratory system are more noteworthy in bronchoscopy, which may lead to hypoxia. These drawbacks may hinder functional recovery and delay the discharge time. Hence, physicians are searching for an optimal sedation regimen for bronchoscopy.
Esketamine, the s-enantiomer of ketamine, is an N-methyl-D-aspartic acid receptor antagonist with potent analgesic and sedative properties. Evidence suggested that esketamine could be used as a component of sedative regimen in many settings, such as endoscopy and endoscopic retrograde cholangiopancreatography. Nevertheless, there remains an evidence gap in the efficacy and safety of esketamine used in bronchoscopy. Therefore, we conducted this study to test the hypothesis that low-dose esketamine as an adjuvant to propofol was non-inferior to propofol alone on the recovery profile and discharge from the hospital after ambulatory bronchoscopy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) classification I-III;
- •Scheduled for ambulatory bronchoscopy.
排除标准
- •Allergic or contraindications to studying drugs
- •History of obstructive sleep apnea-hypopnea syndrome
- •History of psychiatric illness
- •History of neurological disease
- •Pre-existing memory or cognitive impairment
- •History of seizure disorders
- •Substance abuse or intake of drugs that affect the central nervous system
- •Inability to communicate in Mandarin Chinese.
研究组 & 干预措施
0.1 mg/kg esketamine group
Procedure sedation was induced using intravenous 0.1 mg/kg esketamine and propofol 1 mg/kg. Afterward, propofol 0.5 mg/kg was administered to maintain the target sedation level (MOAA/S of less than three).
干预措施: 0.1 mg/kg esketamine (Drug)
0.1 mg/kg esketamine group
Procedure sedation was induced using intravenous 0.1 mg/kg esketamine and propofol 1 mg/kg. Afterward, propofol 0.5 mg/kg was administered to maintain the target sedation level (MOAA/S of less than three).
干预措施: Propofol (Drug)
0.2 mg/kg esketamine group
Procedure sedation was induced using intravenous 0.2 mg/kg esketamine and propofol 1 mg/kg. Afterward, propofol 0.5 mg/kg was administered to maintain the target sedation level (MOAA/S of less than three).
干预措施: 0.2 mg/kg esketamine (Drug)
0.2 mg/kg esketamine group
Procedure sedation was induced using intravenous 0.2 mg/kg esketamine and propofol 1 mg/kg. Afterward, propofol 0.5 mg/kg was administered to maintain the target sedation level (MOAA/S of less than three).
干预措施: Propofol (Drug)
Placebo group
Procedure sedation was induced using intravenous 0.9% saline and propofol 1 mg/kg. Afterward, propofol 0.5 mg/kg was administered to maintain the target sedation level (MOAA/S of less than three).
干预措施: 0.9% saline (Drug)
Placebo group
Procedure sedation was induced using intravenous 0.9% saline and propofol 1 mg/kg. Afterward, propofol 0.5 mg/kg was administered to maintain the target sedation level (MOAA/S of less than three).
干预措施: Propofol (Drug)
结局指标
主要结局
Proportions of patients discharged within 30 min after bronchoscopy
时间窗: Up to 40 minutes postoperatively
Discharge readiness will be measured using the Modified Post Anesthetic Discharge Scoring System scale (greater than or equal to nine).
次要结局
- Postoperative quality of recovery(Baseline, up to 72 hours postoperatively)
- Injection pain(Immediately after administering the study drugs, on average 2 minutes)
- Incidence of adverse events(Up to 72 h postoperatively)
- Propofol consumption(During the bronchoscopy procedure)
- Patient willingness to repeat the procedure(24 hours postoperatively)
- Bronchoscopist satisfaction(At completion of bronchoscopy procedure)
- Emergency time(Immediately after the bronchoscopy completely withdrawn, on average 8 minutes)
- Patient satisfaction(At completion of bronchoscopy procedure)
- Patient willingness to recommend screening(24 hours postoperatively)
研究者
Yao Yusheng
Clinical Professor
Fujian Provincial Hospital