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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура Neuraxial anesthesia
  patients undergo surgery with a neuraxial anesthesia based on spinal or epidural anesthesia using local anesthetics combined with sedation.
• Процедура General Anesthesia
  patients undergo surgery with a general anesthesia using classical GABAergic-drugs.
• Препарат avoidance of GABAergic-drugs strategy
  Sedation based on dexmedetomidine and low dosage of ketamine, avoiding GABAergic-drugs
• Препарат use of GABAergic-drugs
  General anesthesia using classical GABAergic-drugs such as propofol, remifentanil and rocuronium.
• Процедура mechanical ventilation (MV)
  Abdomino-pelvic Surgery managed in general anesthesia needs orotracheal intubation and mechanical ventilation

Первичные конечные точки

• Number of patients effectively managed with neuraxial approach [Срок оценки: Periprocedural]

Вторичные конечные точки (9)

• Postoperative cognitive disfunction [Срок оценки: The moment of enrollement and at 30 days follow-up and one year.]
• Postoperative delirium. [Срок оценки: The moment of enrollement, post operative 0,1,2,3 and day of discharge.]
• Polmonary complications. [Срок оценки: The moment of enrollement, postoperative days 1,2,3.]
• Renal function [Срок оценки: Day of enrollement, postoperative days 1,2,3.]
• In hospital lenght of stay [Срок оценки: day of discharge (up to 1 month)]
• Complications [Срок оценки: up to 30 days and 1 year]
• Recovery after surgery [Срок оценки: From date of randomization until the date of first documented progression, assessed up to 1 month.]
• Renal arterial perfusion [Срок оценки: Day of enrollment, postoperative days 1,2,3]
• Renal congestion [Срок оценки: day of enrollment, postoperative days 1,2,3]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Италия · 2 центра

• E.O. Ospedali Galliera — Genova
• AO di Circolo di Melegnano — Vizzolo Predabissi

Идентификаторы

NCT: NCT07486336 · 79UCS2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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