NCT07486336

Awareness Neuraxial Versus General Anesthesia in Frail Patients Undergoing Laparoscopic or Robotic Abdominopelvic Surgery.

Neuraxial Anesthesia Awareness Versus General Anesthesia in Frail Patients Undergoing Elective Laparoscopic or Robotic Abdominopelvic Surgery: A Pilot Randomized Controlled Trial.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Ente Ospedaliero Ospedali Galliera · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Fraily
• Abdominal Surgery
• Postoperative Cognitive Dysfunction (POCD)

Interventions

Type	Name	Description
PROCEDURE	Neuraxial anesthesia	patients undergo surgery with a neuraxial anesthesia based on spinal or epidural anesthesia using local anesthetics combined with sedation.
PROCEDURE	General Anesthesia	patients undergo surgery with a general anesthesia using classical GABAergic-drugs.
DRUG	avoidance of GABAergic-drugs strategy	Sedation based on dexmedetomidine and low dosage of ketamine, avoiding GABAergic-drugs
DRUG	use of GABAergic-drugs	General anesthesia using classical GABAergic-drugs such as propofol, remifentanil and rocuronium.
PROCEDURE	mechanical ventilation (MV)	Abdomino-pelvic Surgery managed in general anesthesia needs orotracheal intubation and mechanical ventilation

Timeline

• Start date: 2026-09-01
• Primary completion: 2028-09-01
• Completion: 2029-01-01
• First posted: 2026-03-20
• Last updated: 2026-03-20

Locations

2 sites across 1 country: Italy