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

March 17, 2026 updated by: Claudia Brusasco, Ente Ospedaliero Ospedali Galliera

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Genova, Italy, 16128
        • E.O. Ospedali Galliera
        • Contact:
        • 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:
        • Principal Investigator:
          • Davide Vailati, MD
        • Sub-Investigator:
          • Benedetta Basta, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Periprocedural

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
The moment of enrollement and at 30 days follow-up and one year.
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.
The moment of enrollement, post operative 0,1,2,3 and day of discharge.
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.
The moment of enrollement, postoperative days 1,2,3.
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.
Day of enrollement, postoperative days 1,2,3.
In hospital lenght of stay
Time Frame: day of discharge (up to 1 month)
Lenght of stay (n° days)
day of discharge (up to 1 month)
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).
up to 30 days and 1 year
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.
From date of randomization until the date of first documented progression, assessed up to 1 month.
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)
Day of enrollment, postoperative days 1,2,3
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).
day of enrollment, postoperative days 1,2,3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ente Ospedaliero Ospedali Galliera

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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