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.
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
coagulation disorders
severe spinal deformities
known allergy to local anesthetics
severe aortic stenosis
Parallel
Neuraxial anesthesia
Procedure/Surgerypatients undergo surgery with a neuraxial anesthesia based on spinal or epidural anesthesia using local anesthetics combined with sedation.
General Anesthesia
Procedure/Surgerypatients undergo surgery with a general anesthesia using classical GABAergic-drugs.
avoidance of GABAergic-drugs strategy
DrugSedation based on dexmedetomidine and low dosage of ketamine, avoiding GABAergic-drugs
use of GABAergic-drugs
DrugGeneral anesthesia using classical GABAergic-drugs such as propofol, remifentanil and rocuronium.
mechanical ventilation (MV)
Procedure/SurgeryAbdomino-pelvic Surgery managed in general anesthesia needs orotracheal intubation and mechanical ventilation
Number of patients effectively managed with neuraxial approach
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.
Postoperative cognitive disfunction
Postoperative cognitive dysfunction will be assessed using the Montreal Cognitive assessment (MoCA). A MoCA score \> 26 will be considered normal, where as a score \< 26 will indicated cognitive dysfunction. Lower scores correspond to grater severity of detected cognitive impairment.
Postoperative delirium.
Postoperative delirium will be assessed using 3D CAM, on a rating scale where a value of 0 indicates no delirium and a maximum value of 7 indicates the most severe degree.
Polmonary complications.
Pulmonary complications will be assessed through a lung ultrasound (lung pocus), the score of which includes a minimum value of 0 representing normality and a maximum value of 36 describing the presence of widespread consolidation in all 12 lung areas explored.
Renal function
Postoperative renal function is assessed using the KDIGO score, where 1 represents mild renal insufficiency and 3 represents severe renal insufficiency.
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