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ClinicalTrials.gov ID

NCT07486336

Lead Sponsor

Ente Ospedaliero Ospedali GallieraOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

100Estimated

Last Update Posted

Mar 20, 2026Actual

Start Date

Sep 1, 2026Estimated

Primary Completion Date

Sep 1, 2028Estimated

Completion Date

Jan 1, 2029Estimated

Official Title

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

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.

• Fraily
• Abdominal Surgery
• Postoperative Cognitive Dysfunction (POCD)

• Neuraxial anesthesia
• General Anesthesia
• avoidance of GABAergic-drugs strategy
• use of GABAergic-drugs
• mechanical ventilation (MV)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Other

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Ente Ospedaliero Ospedali GallieraOTHER

davide.vailati@asst-melegnano-martesana.it0039 0298052377