Awareness Neuraxial Versus General Anesthesia in Frail Patients Undergoing Laparoscopic or Robotic Abdominopelvic Surgery.
Starting soon · Not applicable
Conditions studied: Fraily, Abdominal Surgery, Postoperative Cognitive Dysfunction (POCD)
In brief
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.
Key facts
- Study ID
- NCT07486336
- Run by
- Ente Ospedaliero Ospedali Galliera
- People needed
- 100
- Starts
- 2026-09-01
- Expected to finish
- 2029-01-01
- Last updated by the study team
- 2026-03-20
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- E.O. Ospedali Galliera — Genova, Italy
- AO di Circolo di Melegnano — Vizzolo Predabissi, Italy
Full record on ClinicalTrials.gov
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