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Awareness Neuraxial Versus General Anesthesia in Frail Patients Undergoing Laparoscopic or Robotic Abdominopelvic Surgery.
NCT07486336 · Ente Ospedaliero Ospedali Galliera · Updated 20 March 2026
- What is being tested
- Neuraxial anesthesia; General Anesthesia; avoidance of GABAergic-drugs strategy; use of GABAergic-drugs; mechanical ventilation (MV)
- For
- Fraily; Abdominal Surgery; Postoperative Cognitive Dysfunction (POCD)
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 60 years and older. About 100 people. The full rules are on the registry page.
- Where
- Italy (2 sites)
- When
- Starts or started 1 Sept 2026, ends 1 Jan 2029. Registered 20 March 2026.
- Results
- None posted yet.
In the researchers' words
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…
Sites
- E.O. Ospedali GallieraGenova, Italy
- AO di Circolo di MelegnanoVizzolo Predabissi, Italy
