Assessment of Residual Paralysis in Patients Who Receive Mini-dose Atracurium During Supraglottic Airway Insertion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 337
- 试验地点
- 1
- 主要终点
- Number of patients with Post operative residual paralysis as measured by Train of Four (TOF) Ratio of < 0.9
研究概览
简要总结
This study aims to establish the incidence of residual paralysis in patients following administration of a mini- dose of atracurium (less than ED95 i.e. <0.23mg/kg or <15 mg in most patients) during supraglottic airway insertion and correlate it with the duration of time from drug administration to arrival at PACU. The secondary aim is to compare the incidence of residual paralysis in patients who receive full doses of atracurium (per body weight) with those who receive mini-doses.
详细描述
Post-operative residual paralysis may be defined as the incomplete recovery of muscle function following intra-operative administration of neuromuscular blockers (NMBs). This condition is associated with many negative patient outcomes such as: increased risk of aspiration; upper airway obstruction; and delayed Post-Anaesthetic Care Unit (PACU) discharge, amongst others. Despite the increasing use of shorter acting agents, the prevalence of residual paralysis in the PACU remains high at 20-50%. NMBs are commonly used to facilitate endotracheal intubation and insertion of the supraglottic airway by obtunding airway reflexes. Given the increasing use of mini-dose NMBs without post-operative reversal in clinical practice, there is a need to evaluate the incidence of residual paralysis in the patient population who have received mini-dose atracurium during the supraglottic airway insertion.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults above 21 years old
- •Received either a mini-dose of atracurium or full dose of atracurium during the placement of the supraglottic airway
- •Did not receive any neuromuscular reversal agent at any point of the operation.
排除标准
- •Patients with underlying neuromuscular disease
- •Patients who received pre-operative medication that may affect neuromuscular transmission
- •Patients who required additional doses of neuromuscular blockade at any point of the operation
结局指标
主要结局
Number of patients with Post operative residual paralysis as measured by Train of Four (TOF) Ratio of < 0.9
时间窗: Through study completion, up to 4 months
Measuring the extent of operative paralysis using established methods such as the train of four (TOF) with ratio of \<0.9 indicating inadequate recovery, Double burst stimulation, acceleromyography, five second head lift and tongue depressor test. The relevant data about the patient's condition will be collected and filled up in the data collection form.
次要结局
未报告次要终点