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

NCT07486336 | Not Yet Recruiting

• 1 other identifier: 79UCS2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Fraily; Abdominal Surgery; Postoperative Cognitive Dysfunction (POCD)

Keywords

neuraxial anesthesia; awake surgery; frailty; postoperative delirium; cognitive outcomes; perioperative medicine; enhanced recovery after surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Postoperative cognitive disfunction

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

• Postoperative delirium.

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

• Polmonary complications.

  The moment of enrollement, postoperative days 1,2,3.

• Renal function

  Day of enrollement, postoperative days 1,2,3.

• In hospital lenght of stay

  day of discharge (up to 1 month)

Study Arms (2)

neuraxial anesthesia combined with sedation

ACTIVE COMPARATOR

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

General anesthesia

ACTIVE COMPARATOR

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)

Interventions

Neuraxial anesthesia PROCEDURE

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

neuraxial anesthesia combined with sedation

General Anesthesia PROCEDURE

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

General anesthesia

use of GABAergic-drugs DRUG

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

General anesthesia

avoidance of GABAergic-drugs strategy DRUG

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

neuraxial anesthesia combined with sedation

mechanical ventilation (MV) PROCEDURE

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

General anesthesia

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ente Ospedaliero Ospedali Galliera: lead

Study Sites (2)

E.O. Ospedali Galliera

Genova, 16128, Italy

Location

AO di Circolo di Melegnano

Vizzolo Predabissi, 20070, Italy

Location

MeSH Terms

Conditions

Postoperative Cognitive Complications; Frailty; Emergence Delirium

Interventions

Anesthesia, General; Respiration, Artificial

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Central Study Contacts

Claudia Brusasco, MD, PhD

CONTACT

0039 3291185009; claudia.brusasco@galliera.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD Anesthesiologist

Model Details: This is a bicentric, prospective, randomized, parallel-group study.

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: March 20, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

IT (2)