Awareness Neuraxial Versus General Anesthesia in Frail Patients Undergoing Laparoscopic or Robotic Abdominopelvic Surgery.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neuraxial anesthesia, General Anesthesia, avoidance of GABAergic-drugs strategy, use of GABAergic-drugs.
- Who it may be relevant to
- Registry conditions: Fraily, Abdominal Surgery, Postoperative Cognitive Dysfunction (POCD). Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Neuraxial Anesthesia Awareness Versus General Anesthesia in Frail Patients Undergoing Elective Laparoscopic or Robotic Abdominopelvic Surgery: A Pilot Randomized Controlled Trial.
Overview
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.
Interventions
- Procedure Neuraxial anesthesia
patients undergo surgery with a neuraxial anesthesia based on spinal or epidural anesthesia using local anesthetics combined with sedation. - Procedure General Anesthesia
patients undergo surgery with a general anesthesia using classical GABAergic-drugs. - Drug avoidance of GABAergic-drugs strategy
Sedation based on dexmedetomidine and low dosage of ketamine, avoiding 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
Primary outcome measures
- Number of patients effectively managed with neuraxial approach [Time frame: Periprocedural]
Secondary outcome measures (9)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Italy · 2 centers
- E.O. Ospedali Galliera — Genova
- AO di Circolo di Melegnano — Vizzolo Predabissi
Identifiers
NCT: NCT07486336 · 79UCS2025