Awareness Neuraxial Versus General Anesthesia in Frail Patients Undergoing Laparoscopic or Robotic Abdominopelvic Surgery. (SAFE-AWARENESS)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Abdominal Surgery; Postoperative Cognitive Dysfunction (POCD); Fraily
• Intervention / Treatment: Procedure: Neuraxial anesthesia; Drug: avoidance of GABAergic-drugs strategy; Procedure: General Anesthesia; Drug: use of GABAergic-drugs; Procedure: mechanical ventilation (MV)

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claudia Brusasco, MD, PhD; Phone Number: 0039 3291185009; Email: claudia.brusasco@galliera.it

Study Locations

• Italy
  • Genova, Italy, 16128
    • E.O. Ospedali Galliera
    • Contact: Claudia Brusasco, MD, PhD; Phone Number: 00393291185009; Email: claudia.brusasco@galliera.it
    • Sub-Investigator: Marco Micali, Md
    • Principal Investigator: Claudia Brusasco, MD, PhD
    • Sub-Investigator: Federico Germinale, MD
    • Principal Investigator: Carlo Introini, Md
    • Sub-Investigator: Maura Marcucci, MD, PhD
  • Vizzolo Predabissi, Italy, 20070
    • AO di Circolo di Melegnano
    • Contact: Davide Vailati, MD; Phone Number: 0039 0298052377; Email: davide.vailati@asst-melegnano-martesana.it
    • Principal Investigator: Davide Vailati, MD
    • Sub-Investigator: Benedetta Basta, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: neuraxial anesthesia combined with sedation; patients are submitted to laparoscopic or robotic abdominopelvic surgery with a neuraxial anesthesia combined with sedation.	Procedure: Neuraxial anesthesia; patients undergo surgery with a neuraxial anesthesia based on spinal or epidural anesthesia using local anesthetics combined with sedation.; Drug: avoidance of GABAergic-drugs strategy; Sedation based on dexmedetomidine and low dosage of ketamine, avoiding GABAergic-drugs
Active Comparator: General anesthesia; patients are submitted to laparoscopic or robotic abdominopelvic surgery undergoing a general anesthesia.	Procedure: General Anesthesia; patients undergo surgery with a general anesthesia using classical 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Periprocedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Day of enrollement, postoperative days 1,2,3.
In hospital lenght of stay	Lenght of stay (n° days)	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).	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.	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)	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).	day of enrollment, postoperative days 1,2,3

Collaborators and Investigators

• Sponsor: Ente Ospedaliero Ospedali Galliera

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: January 27, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: frailty; postoperative delirium; enhanced recovery after surgery; neuraxial anesthesia; awake surgery; perioperative medicine; cognitive outcomes
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Delirium; Cognitive Dysfunction; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Frailty; Postoperative Cognitive Complications; Emergence Delirium; Therapeutics; Anesthesia and Analgesia; Airway Management; Resuscitation; Emergency Treatment; Respiratory Therapy; Anesthesia; Respiration, Artificial; Anesthesia, General
• Other Study ID Numbers: 79UCS2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We share the entire study protocol (English version) and the CRF (Italian version).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No