Effect of Sarcopenia and Frailty on Rocuronium Pharmacodynamics in Geriatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Rocuronium onset time
研究概览
简要总结
This prospective observational study aims to evaluate whether sarcopenia and frailty affect the pharmacodynamic profile of rocuronium in geriatric patients undergoing elective surgery under general anesthesia.
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
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo elective surgery under general anesthesia requiring endotracheal intubation
- •Planned use of rocuronium for neuromuscular blockade
- •Quantitative neuromuscular monitoring planned during anesthesia
- •American Society of Anesthesiologists physical status I-III
- •Ability to provide written informed consent
- •Completion of preoperative frailty and sarcopenia assessment
排除标准
- •Emergency surgery
- •Known neuromuscular disease
- •History of allergy or contraindication to rocuronium, sugammadex
- •Severe hepatic insufficiency
- •Severe renal insufficiency
- •Use of drugs known to significantly affect neuromuscular transmission
- •Preoperative mechanical ventilation or intensive care unit admission
- •Inability to perform a frailty or sarcopenia assessment
- •Patients in whom quantitative neuromuscular monitoring cannot be properly performed
- •Refusal to participate in the study
研究组 & 干预措施
Group/Cohort 3 - Frail and Sarcopenic Group
Geriatric patients who meet the criteria for both frailty and sarcopenia.
Group/Cohort 4 - Control Group
Geriatric patients who meet neither frailty nor sarcopenia criteria.
Group/Cohort 1-Frailty
Presence of frailty based on the Fried frailty phenotype.
Group/Cohort 2-Sarcopenia
Presence of sarcopenia based on preoperative clinical and ultrasonographic assessment.
结局指标
主要结局
Rocuronium onset time
时间窗: Perioperative/Periprocedural - during anesthesia induction
Time from intravenous administration of rocuronium to disappearance of all train-of-four responses, defined as train-of-four count 0, measured using quantitative neuromuscular monitoring
次要结局
- Time from train-of-four count 0 to train-of-four count 2(From achievement of train-of-four count 0 after the initial rocuronium dose until recovery of train-of-four count 2 during surgery)
- Time to train-of-four ratio 0.9 after sugammadex administration(From sugammadex administration until recovery of train-of-four ratio to 0.9 at the end of surgery)
- Total rocuronium dose(From anesthesia induction until the end of surgery)
研究者
Betul Kozanhan
Prof. Dr.
Konya Meram State Hospital