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NCT Number: NCT07486336

Awareness Neuraxial Versus General Anesthesia in Frail Patients Undergoing Laparoscopic or Robotic Abdominopelvic Surgery.

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.

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Key information

Conditions

Fraily Abdominal Surgery Cognition Disorders Cognitive Dysfunction Confusion Delirium Emergence Delirium Frailty Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Cognitive Complications Postoperative Cognitive Dysfunction (POCD) Postoperative Complications Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

E.O. Ospedali Galliera, Genova, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuraxial anesthesia

Procedure

patients undergo surgery with a neuraxial anesthesia based on spinal or epidural anesthesia using local anesthetics combined with sedation.

General Anesthesia

Procedure

patients undergo surgery with a general anesthesia using classical GABAergic-drugs.

avoidance of GABAergic-drugs strategy

Drug

Sedation based on dexmedetomidine and low dosage of ketamine, avoiding GABAergic-drugs

use of GABAergic-drugs

Drug

General anesthesia using classical GABAergic-drugs such as propofol, remifentanil and rocuronium.

mechanical ventilation (MV)

Procedure

Abdomino-pelvic Surgery managed in general anesthesia needs orotracheal intubation and mechanical ventilation

Primary outcomes

  1. Number of patients effectively managed with neuraxial approach

    Time frame: Periprocedural

    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.

Secondary outcomes

  1. Postoperative cognitive disfunction

    Time frame: The moment of enrollement and at 30 days follow-up and one year.

    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.

  2. Postoperative delirium.

    Time frame: The moment of enrollement, post operative 0,1,2,3 and day of discharge.

    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.

  3. Polmonary complications.

    Time frame: The moment of enrollement, postoperative days 1,2,3.

    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.

  4. Renal function

    Time frame: Day of enrollement, postoperative days 1,2,3.

    Postoperative renal function is assessed using the KDIGO score, where 1 represents mild renal insufficiency and 3 represents severe renal insufficiency.

  5. In hospital lenght of stay

    Time frame: day of discharge (up to 1 month)

    Lenght of stay (n° days)

  6. Complications

    Time frame: up to 30 days and 1 year

    Occurence of short-and medium-term postoperative complications (Clavien -Dindo classification from grade 1 to grade 5).

  7. Recovery after surgery

    Time frame: From date of randomization until the date of first documented progression, assessed up to 1 month.

    Day to recovery of oral intake (n°) Day to first mobilization (n°) These outcomes aim to evaluate the overall impact to ERAS principles.

  8. Renal arterial perfusion

    Time frame: Day of enrollment, postoperative days 1,2,3

    Renal Doppler ultrasound is also performed, calculating the renal resistance index, which is normally <0.7 (range 0-1)

  9. Renal congestion

    Time frame: day of enrollment, postoperative days 1,2,3

    Renal Doppler ultrasound is also performed to assess venous congestion index, which is normally 0 (range 0-1).

Study contacts

Contact information is provided by the study sponsor or research team.

Claudia Brusasco, MD, PhD

CONTACT

[email protected]

0039 3291185009

Sponsors and collaborators

Lead sponsor

Ente Ospedaliero Ospedali Galliera

Other

Registry information

Official study title

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

Acronym: SAFE-AWARENESS

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Mar 20, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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