FrailySAFE-AWARENESSNCT07486336
Awareness Neuraxial Versus General Anesthesia in Frail Patients Undergoing Laparoscopic or Robotic Abdominopelvic Surgery.
A study testing Neuraxial anesthesia, General Anesthesia and avoidance of GABAergic-drugs strategy in people with Fraily and Abdominal Surgery, run by Ente Ospedaliero Ospedali Galliera at 2 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Fraily, Abdominal Surgery, Postoperative Cognitive Dysfunction (POCD)
- What is being tested?
- Neuraxial anesthesia, General Anesthesia and avoidance of GABAergic-drugs strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Sep 2026to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites
E.O. Ospedali Galliera
Genova, 16128
Claudia Brusasco, MD, PhD, 00393291185009, claudia.brusasco@galliera.it
Marco Micali, Md
AO di Circolo di Melegnano
Vizzolo Predabissi, 20070
Davide Vailati, MD, 0039 0298052377, davide.vailati@asst-melegnano-martesana.it
Davide Vailati, MD
About this study
Official title: 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.
Read more
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.
- Being tested
- Neuraxial anesthesia, General Anesthesia, avoidance of GABAergic-drugs strategy, use of GABAergic-drugs, mechanical ventilation (MV)
- Keywords
- neuraxial anesthesia, awake surgery, frailty, postoperative delirium, cognitive outcomes, perioperative medicine, enhanced recovery after surgery
- Medical subject headings
- Postoperative Cognitive Complications, Frailty, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuraxial anesthesiaProcedure or surgery
patients undergo surgery with a neuraxial anesthesia based on spinal or epidural anesthesia using local anesthetics combined with sedation.
General AnesthesiaProcedure or surgery
patients undergo surgery with a general anesthesia using classical GABAergic-drugs.
avoidance of GABAergic-drugs strategyDrug
Sedation based on dexmedetomidine and low dosage of ketamine, avoiding GABAergic-drugs
use of GABAergic-drugsDrug
General anesthesia using classical GABAergic-drugs such as propofol, remifentanil and rocuronium.
mechanical ventilation (MV)Procedure or surgery
Abdomino-pelvic Surgery managed in general anesthesia needs orotracheal intubation and mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| neuraxial anesthesia combined with sedation | Active comparator | patients are submitted to laparoscopic or robotic abdominopelvic surgery with a neuraxial anesthesia combined with sedation. Receives: Procedure: Neuraxial anesthesia; Drug: avoidance of GABAergic-drugs strategy |
| General anesthesia | Active comparator | patients are submitted to laparoscopic or robotic abdominopelvic surgery undergoing a general anesthesia. Receives: Procedure: General Anesthesia; Drug: use of GABAergic-drugs; Procedure: mechanical ventilation (MV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Periprocedural
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day of enrollement, postoperative days 1,2,3.
In hospital lenght of stay
Lenght of stay (n° days)
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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).
Measured: day of enrollment, postoperative days 1,2,3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a bicentric, prospective, randomized, parallel-group study.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ente Ospedaliero Ospedali Galliera
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Brusasco, Ente Ospedaliero Ospedali Galliera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486336
- Sponsor's protocol ID
- 79UCS2025
- Acronym
- SAFE-AWARENESS
- Status last verified
- Mar 2026
- First submitted
- 27 Jan 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We share the entire study protocol (English version) and the CRF (Italian version).
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuraxial Anesthesia Awareness Versus General Anesthesia in Frail Patients Undergoing Elective Laparoscopic or Robotic Abdominopelvic Surgery: A Pilot Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07486336
- Acronym / sponsor ID
- SAFE-AWARENESS / 79UCS2025
- Keywords
- neuraxial anesthesia, awake surgery, frailty, postoperative delirium, cognitive outcomes, perioperative medicine, enhanced recovery after surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ente Ospedaliero Ospedali GallieraUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a bicentric, prospective, randomized, parallel-group study.
| Arm | Type | Receives |
|---|---|---|
| neuraxial anesthesia combined with sedation | Active comparator | Procedure: Neuraxial anesthesia, Drug: avoidance of GABAergic-drugs strategypatients are submitted to laparoscopic or robotic abdominopelvic surgery with a neuraxial anesthesia combined with sedation. |
| General anesthesia | Active comparator | Procedure: General Anesthesia, Drug: use of GABAergic-drugs, Procedure: mechanical ventilation (MV)patients are submitted to laparoscopic or robotic abdominopelvic surgery undergoing a general anesthesia. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Patients undergoing open (laparotomic) or emergency surgery, or presenting contraindications to central locoregional (neuraxial) anesthesia, specifically:
- Any systemic disease that, in the investigator's judgment, is not compatible with participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuraxial anesthesiapatients undergo surgery with a neuraxial anesthesia based on spinal or epidural anesthesia using local anesthetics combined with sedation. | Procedure or surgery | neuraxial anesthesia combined with sedation |
| General Anesthesiapatients undergo surgery with a general anesthesia using classical GABAergic-drugs. | Procedure or surgery | General anesthesia |
| avoidance of GABAergic-drugs strategySedation based on dexmedetomidine and low dosage of ketamine, avoiding GABAergic-drugs | Drug | neuraxial anesthesia combined with sedation |
| use of GABAergic-drugsGeneral anesthesia using classical GABAergic-drugs such as propofol, remifentanil and rocuronium. | Drug | General anesthesia |
| mechanical ventilation (MV)Abdomino-pelvic Surgery managed in general anesthesia needs orotracheal intubation and mechanical ventilation | Procedure or surgery | General anesthesia |
Primary outcome
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.
9 secondary outcomes
Postoperative cognitive disfunction
Time frame: 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.
Polmonary complications.
Time frame: The moment of enrollement, postoperative days 1,2,3.
Renal function
Time frame: Day of enrollement, postoperative days 1,2,3.
In hospital lenght of stay
Time frame: day of discharge (up to 1 month)
Complications
Time frame: 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.
Renal arterial perfusion
Time frame: Day of enrollment, postoperative days 1,2,3
Renal congestion
Time frame: day of enrollment, postoperative days 1,2,3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: Yes. We share the entire study protocol (English version) and the CRF (Italian version).
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuraxial anesthesia, General Anesthesia and avoidance of GABAergic-drugs strategy in people with Fraily and Abdominal Surgery, run by Ente Ospedaliero Ospedali Galliera at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudia Brusasco, MD, PhD (0039 3291185009, claudia.brusasco@galliera.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients effectively managed with neuraxial approach (time frame: Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.