The Effect of Different Depths of Neuromuscular Blockade, Assessed by Train of Four (TOF) Monitoring, On Driving Pressure and the Development of Postoperative Critical Respiratory Events in Abdominal Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Mean Intraoperative Driving Pressure
研究概览
简要总结
This randomized controlled study aims to evaluate the effects of deep versus moderate neuromuscular blockade on intraoperative driving pressure and the development of postoperative critical respiratory events in patients undergoing abdominal surgery under general anesthesia.
详细描述
Patients will be randomized into two groups:
Deep neuromuscular blockade group (TOF count 0, PTC 1-2) Moderate neuromuscular blockade group (TOF count 1-2) Driving pressure (Plateau pressure - PEEP) will be recorded intraoperatively. Postoperative critical respiratory events will be assessed within 30 minutes in the post anesthesia care unit (PACU).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elective abdominal surgery under general anesthesia that is expected to last longer than one hour
- •ASA I-II-III
- •Age ≥18 years
- •Written informed consent
排除标准
- •Refusal to participate in the study
- •Obesity (BMI>30) and cachexia (BMI <18)
- •Laparoscopic surgery
- •Emergency procedure
- •Allergy to drugs used during induction and maintenance of general anesthesia
- •Presence of psychiatric/neurologic/neuromuscular disease
- •Risk of malignant hyperthermia or having any relative with history of malignant hyperthermia
- •Use of medications that may affect neuromuscular function (anticonvulsants, aminoglycosides, magnesium salts, etc.)
- •Pregnancy
- •Presence of advanced chronic lung disease (asthma, COPD, etc.)
- •Presence of advanced liver and renal disease (creatinine>1.6, liver function tests above twice the normal range)
研究组 & 干预措施
Arm 1: Deep Neuromuscular Block
Deep Neuromuscular Block: Rocuronium titrated according to quantitative neuromuscular monitoring [Post-Tetanic count (PTC): ≥1; Train of Four (TOF) Count: 0]
干预措施: Rocuronium (Drug)
Arm 2: Moderate Neuromuscular Block
Moderate Neuromuscular Block: Rocuronium titrated according to quantitative neuromuscular monitoring [Train of Four (TOF) Count: 1-3]
干预措施: Rocuronium (Drug)
结局指标
主要结局
Mean Intraoperative Driving Pressure
时间窗: From immediately after intubation until the end of surgery (intraoperative period)
Driving pressure will be calculated as plateau pressure minus positive end-expiratory pressure (PEEP) during volume-controlled ventilation. Measurements will be recorded at 30-minute intervals throughout surgery, and the mean value per patient will be calculated.
次要结局
- Incidende of Postoperative Critical Respiratory Events(From immediately after extubation and until 30 minutes after arrival to PACU)
研究者
ismail aytaç
Associate Professor
Ankara City Hospital Bilkent