Neuraxial Anesthesia Awareness Versus General Anesthesia in Frail Patients Undergoing Elective Laparoscopic or Robotic Abdominopelvic Surgery: A Pilot Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of patients effectively managed with neuraxial approach
研究概览
简要总结
This is a bicentric, prospective, non-pharmacological, randomized study designed to compare the efficacy and safety of awake neuraxial anesthesia with sedation versus general anesthesia in frail patients undergoing elective major laparoscopic or robotic abdominopelvic surgery.
A total of 100 frail patients aged over 60 years, with ASA physical status >2 and evidence of frailty and/or cognitive vulnerability, will be randomized to receive either standard general anesthesia with mechanical ventilation or thoracic neuraxial anesthesia combined with non-GABAergic sedation while maintaining spontaneous breathing.
The primary objective is to evaluate the feasibility in terms of recruitment of a RCT conducted in a population of frail or cognitively impaired patients undergoing major laparoscopic abdominal surgery, randomized to a neuraxial or general anesthetic approach in which the effects on the onset of postoperative delirium and postoperative cognitive dysfunction (POCD) will be determined. Secondary outcomes include the occurrence of postoperative organ dysfunction (respiratory, cardiovascular, renal, and metabolic), length of hospital stay, time to recovery after surgery, and postoperative mortality.
Patients will undergo comprehensive perioperative clinical, laboratory, and ultrasound assessments, including lung and renal ultrasound evaluations. Neurological and functional status will be assessed during hospitalization, at 1 month, and via telephone follow-up at 1 year after surgery.
The aim of the study is to evaluate the feasibility and safety of performing two different anesthetic techniques on fragile patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 60 years
- •Willingness to participate in the study and written informed consent
- •ASA physical status > 2
- •Frailty score > 5 and/or AMT-10 < 6
- •Laparoscopic or robotic major elective abdominopelvic surgery
排除标准
- •Patients undergoing open (laparotomic) or emergency surgery, or presenting contraindications to central locoregional (neuraxial) anesthesia, specifically:
- •coagulation disorders
- •severe spinal deformities
- •known allergy to local anesthetics
- •severe aortic stenosis
- •systemic sepsis
- •infection at the puncture site
- •Any systemic disease that, in the investigator's judgment, is not compatible with participation in the study
结局指标
主要结局
Number of patients effectively managed with neuraxial approach
时间窗: Periprocedural
Evaluate feasibility in terms of number of patients recruited and number of patients randomized to neuraxial anesthetic approach effectively managed in neuraxial anesthetic approach throughout all the procedure.
次要结局
- In hospital lenght of stay(day of discharge (up to 1 month))
- Postoperative cognitive disfunction(The moment of enrollement and at 30 days follow-up and one year.)
- Postoperative delirium.(The moment of enrollement, post operative 0,1,2,3 and day of discharge.)
- Polmonary complications.(The moment of enrollement, postoperative days 1,2,3.)
- Renal function(Day of enrollement, postoperative days 1,2,3.)
- Complications(up to 30 days and 1 year)
- Recovery after surgery(From date of randomization until the date of first documented progression, assessed up to 1 month.)
- Renal arterial perfusion(Day of enrollment, postoperative days 1,2,3)
- Renal congestion(day of enrollment, postoperative days 1,2,3)
研究者
Claudia Brusasco
MD PhD Anesthesiologist
Ente Ospedaliero Ospedali Galliera