Incidence of Postoperative Residual Neuromuscular Blockade - A Multicenter, Observational Study in Portugal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 366
- 试验地点
- 10
- 主要终点
- Percentage of Patients With Postoperative Residual Neuromuscular Blockade
研究概览
简要总结
This is an epidemiological multicenter, observational, prospective study, designed to determine the incidence of postoperative residual neuromuscular blockade - defined by a TOF (train-of-four) ratio < 0.9 - at PACU arrival.
Subjects aged at least 18 years old (n=360) admitted for different types of elective surgical procedures requiring general anesthesia with neuromuscular blocking agents will be included.
详细描述
This is a multicenter, observational/non-interventional study involving adult patients undergoing different types of elective surgical procedures requiring general anesthesia with neuromuscular blocking agents.
The study will have two periods:
- Period 1 - Evaluation at PACU arrival.
- Period 2 - Collection of hospital patient discharge data.
A total of 360 patients will be included from approximately 10 centers in Portugal, where the PACU is adjacent to the Operating Room (OR). Each center should recruit between 30 and 40 patients.
Each subject is considered to be enrolled in the study when the subject has provided written informed consent.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18 years of age or older;
- •Informed consent signed;
- •Admission for elective surgery;
- •Administration of non-depolarizing NMBAs during surgery
排除标准
- •Admission for emergency surgery;
- •Reoperation on the same hospital admission;
- •More than 10 minutes elapsed between extubation and neuromuscular block monitoring at PACU
结局指标
主要结局
Percentage of Patients With Postoperative Residual Neuromuscular Blockade
时间窗: No more than 10 minutes after operating room exit
Percentage of patients arriving PACU with a TOF ratio \< 0.9 measured as average of 3 consecutive TOF stimulations
次要结局
- Percentage of Patients With Severe Residual Postoperative Neuromuscular Blockade(no more than 10 minutes after operating room exit)
- Association of Postoperative Residual Blockade and the Use of Reversal Agents(no more than 10 minutes after operating room exit)
- Association of Postoperative Residual Blockade and the Use of Intra-operative Monitoring of Neuromuscular Blockade(no more than 10 minutes after operating room exit)
研究者
Simao Esteves
MD
Centro Hospitalar do Porto