Incidence of Residual Neuromuscular Block in Adult Patients in the Postanesthesia Care Unit. An Observational Cross-sectional Study of a Multicenter Cohort. The Residual Curarization in Spain Study (ReCuSS).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 763
- 试验地点
- 25
- 主要终点
- Residual neuromuscular block incidence (TOFr<0.9) measured by accelerometry in the PACU
研究概览
简要总结
Residual neuromuscular block (RNMB) is frequent in the immediate postoperative period and is a source of complications, mainly respiratory. The incidence is variable due to multiple factors. In Spain the incidence is unknown.
The investigators hypothesize that a number of patients in the postanesthesia care unit (PACU) present with RNMB after general anesthesia using intermediate action neuromuscular block agents (NMBA).
The main objective is to know the incidence of RNMB in Spanish hospitals. Secondary objectives are to observe the possible relationship with other pre- and intraoperative factors.
详细描述
Residual neuromuscular block (RNMB) is frequent in the immediate postoperative period and is a source of complications, mainly respiratory. This includes recovery delay or hospital discharge delays, respiratory insufficiency or infections, unforeseen ICU admissions, and prolonged ICU stays.
The incidence is variable due to multiple factors. Age, gender, surgery, NMBA type and doses, temperature, medications, etc.
In several studies it has been found and incidence between 6-80%. Few studies have been focused in evaluating the incidence in the whole country, as representing a global anesthesia practice. In Spain the incidence is unknown.
The investigators hypothesize that a number of patients in the postanesthesia care unit (PACU) present with RNMB after general anesthesia using intermediate action NMBA.
The main objective is to know the incidence of RNMB in Spanish hospitals, by means of an observational cross-sectional multicenter study .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Patients >18 years-old
- •General anesthesia with non-depolarizing NMBA
- •Transferred extubated on spontaneous ventilation to the PACU
排除标准
- •American Society of Anesthesiologists physical status IV-V
- •emergency and cardiac surgery
- •patients unable to respond adequately at the moment of pre- or postoperative evaluation (psychiatric diseases, excessive somnolence, agitation, etc.)
- •noncompensated diabetes mellitus or diabetic neuropathy
- •symptomatic severe hypothyroidism (or untreated), or scheduled for total thyroidectomy
- •chronic or acute renal insufficiency
- •severe hepatopathy (Child-Pugh B, C)
- •intraoperative blood transfusion >3 blood units
- •intraoperative maintained arterial hypotension
- •arrival to the PACU intubated or with instrumented airway (including surgical)
- •pre- or perioperative drugs intake affecting the neuromuscular transmission
- •neuromuscular diseases affecting the physiology of the neuromuscular system
结局指标
主要结局
Residual neuromuscular block incidence (TOFr<0.9) measured by accelerometry in the PACU
时间窗: Upon arrival to the PACU. Single evaluation.
Patients operated on under general anesthesia including intermediate duration NMBA were evaluated by means of an accelerometer in the PACU immediately upon arrival. Train-of-four ratio (TOFr) is evaluated. The evaluator does'nt know the patient-related information, including intraoperative management.
次要结局
- Respiratory or airway postoperative complications in the PACU(During PACU stay, an expected average of 4 hours)
研究者
Carlos Luis Errando
MD, PhD, staff anesthesiologist
General University Hospital of Valencia