An interventional study of Neuraxial anesthesia and General Anesthesia in Fraily, Abdominal Surgery and Postoperative Cognitive Dysfunction (POCD), sponsored by Ente Ospedaliero Ospedali Galliera. Not yet recruiting at 2 sites in Italy. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-03-20.
Sponsored by Ente Ospedaliero Ospedali Galliera · Not applicable, Interventional, and Other
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.
260 studies on the registry are indexed under Postoperative Cognitive Complications; 55 are open to participants now.
This study's planned enrollment of 100 is close to the median of 107 across 145 interventional studies indexed under Postoperative Cognitive Complications.
Browse Postoperative Cognitive Complications studies →Ente Ospedaliero Ospedali Galliera is the lead sponsor of 19 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Patients undergoing open (laparotomic) or emergency surgery, or presenting to central locoregional (neuraxial) anesthesia, specifically:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients are submitted to laparoscopic or robotic abdominopelvic surgery with a neuraxial anesthesia combined with sedation.
Procedure: Neuraxial anesthesia · Drug: avoidance of GABAergic-drugs strategy
patients are submitted to laparoscopic or robotic abdominopelvic surgery undergoing a general anesthesia.
Procedure: General Anesthesia · Drug: use of GABAergic-drugs · Procedure: mechanical ventilation (MV)
patients undergo surgery with a neuraxial anesthesia based on spinal or epidural anesthesia using local anesthetics combined with sedation.
patients undergo surgery with a general anesthesia using classical GABAergic-drugs.
Sedation based on dexmedetomidine and low dosage of ketamine, avoiding GABAergic-drugs
General anesthesia using classical GABAergic-drugs such as propofol, remifentanil and rocuronium.
Abdomino-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.
Time frame: Periprocedural
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.
Time frame: The moment of enrollement and at 30 days follow-up and one year.
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.
Time frame: The moment of enrollement, post operative 0,1,2,3 and day of discharge.
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.
Time frame: The moment of enrollement, postoperative days 1,2,3.
Renal function
Postoperative renal function is assessed using the KDIGO score, where 1 represents mild renal insufficiency and 3 represents severe renal insufficiency.
Time frame: Day of enrollement, postoperative days 1,2,3.
In hospital lenght of stay
Lenght of stay (n° days)
Time frame: day of discharge (up to 1 month)
Complications
Occurence of short-and medium-term postoperative complications (Clavien -Dindo classification from grade 1 to grade 5).
Time frame: up to 30 days and 1 year
Recovery after surgery
Day to recovery of oral intake (n°) Day to first mobilization (n°) These outcomes aim to evaluate the overall impact to ERAS principles.
Time frame: From date of randomization until the date of first documented progression, assessed up to 1 month.
Renal arterial perfusion
Renal Doppler ultrasound is also performed, calculating the renal resistance index, which is normally \<0.7 (range 0-1)
Time frame: Day of enrollment, postoperative days 1,2,3
Renal congestion
Renal Doppler ultrasound is also performed to assess venous congestion index, which is normally 0 (range 0-1).
Time frame: day of enrollment, postoperative days 1,2,3
Plan to share: Yes — We share the entire study protocol (English version) and the CRF (Italian version).
Supporting information: Study protocol, Clinical study report
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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