Evaluation of Neuromuscular Blockade Responses in Statin-Using and Non-Using Patients Undergoing Elective Surgery Under General Anesthesia, Monitored by Train-of-Four (TOF)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 104
- 主要终点
- Time to reach TOF 40
研究概览
简要总结
This study aims to compare the neuromuscular blockade responses in patients undergoing elective surgery under general anesthesia, with a focus on the use of statins. The study will assess the depth of neuromuscular blockade, recovery time, and postoperative residual curarization using Train-of-Four (TOF) monitoring, with the primary goal of determining whether statin use alters the neuromuscular blockade management.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •ASA classification I, II, III
- •BMI 18-30
- •Statin use for at least 3 months or no prior statin use
- •Elective surgery requiring general anesthesia with endotracheal intubation
- •Signed informed consent for participation in the study
排除标准
- •ASA classification IV or higher
- •BMI <18 or >30
- •History of liver or renal insufficiency (creatinine >1.6, liver function tests >2x normal)
- •Neuromuscular, psychiatric, or neurological disorders
- •Pregnancy
- •Use of drugs affecting neuromuscular function (e.g., anticonvulsants, aminoglycosides)
- •History of malignant hyperthermia
- •Respiratory disorders, including sleep apnea
- •Allergy to anesthetic drugs used in the study
结局指标
主要结局
Time to reach TOF 40
时间窗: about 40th minute
time to intraoperatively TOF reached 40
Time to reach TOF count 0
时间窗: 0th minute
time from administration of rocuronium to reach TOF count 0
Time to reach TOF 90 (reversal of neuromuscular blockade)
时间窗: about 60th minute
Measured postoperatively after sugammadex administration and additional doses if required.
次要结局
未报告次要终点
研究者
ismail aytaç
Ass. Prof. Dr.
Ankara City Hospital Bilkent