What this means
This is a planned trial that has not started yet and has no results. It will test whether a numbing spinal method or general anesthesia works and is safe for frail patients.
Plain-English summary written by an AI model from the registry listing.
- Status
- Opening soon
- Who can join
- Ages 60 and over · 100 frail patients over 60 years old
- Where
- 2 sites
The science
- Registered title
- Awareness Neuraxial Versus General Anesthesia in Frail Patients Undergoing Laparoscopic or Robotic Abdominopelvic Surgery.
- Trial ID
- NCT07486336 ↗
- Phase
- Not applicable
- Study type
- interventional
- Conditions
- Fraily, Abdominal Surgery, Postoperative Cognitive Dysfunction (POCD)
- What is tested
- Neuraxial anesthesia, General Anesthesia, avoidance of GABAergic-drugs strategy, use of GABAergic-drugs, mechanical ventilation (MV)
- Sponsor
- Ente Ospedaliero Ospedali Galliera
- Ages
- 60 Years to no maximum
- Dates
- First posted Mar 20, 2026 · updated Mar 20, 2026
Registry 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.
Sites (2)
- E.O. Ospedali Galliera, Genova, Italy
- AO di Circolo di Melegnano, Vizzolo Predabissi, Italy