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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neuraxial anesthesia combined with sedation | Active Comparator | patients are submitted to laparoscopic or robotic abdominopelvic surgery with a neuraxial anesthesia combined with sedation. |
|
| General anesthesia | Active Comparator | patients are submitted to laparoscopic or robotic abdominopelvic surgery undergoing a general anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuraxial anesthesia | Procedure | patients undergo surgery with a neuraxial anesthesia based on spinal or epidural anesthesia using local anesthetics combined with sedation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The moment of enrollement and at 30 days follow-up and one year. |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claudia Brusasco, MD, PhD | Contact | 0039 3291185009 | claudia.brusasco@galliera.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| E.O. Ospedali Galliera | Genova | 16128 | Italy |
We share the entire study protocol (English version) and the CRF (Italian version).
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This is a bicentric, prospective, randomized, parallel-group study.
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| General Anesthesia | Procedure | patients undergo surgery with a general anesthesia using classical GABAergic-drugs. |
|
| avoidance of GABAergic-drugs strategy | Drug | Sedation based on dexmedetomidine and low dosage of ketamine, avoiding GABAergic-drugs |
|
| use of GABAergic-drugs | Drug | General anesthesia using classical GABAergic-drugs such as propofol, remifentanil and rocuronium. |
|
| mechanical ventilation (MV) | Procedure | Abdomino-pelvic Surgery managed in general anesthesia needs orotracheal intubation and mechanical ventilation |
|
| 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. | 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. | 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. | Day of enrollement, postoperative days 1,2,3. |
| In hospital lenght of stay | Lenght of stay (n° days) | 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). | 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. | 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) | 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). | day of enrollment, postoperative days 1,2,3 |
| AO di Circolo di Melegnano | Vizzolo Predabissi | 20070 | Italy |
|
| ID | Term |
|---|---|
| D000079690 | Postoperative Cognitive Complications |
| D000073496 | Frailty |
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D060825 | Cognitive Dysfunction |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| D012121 | Respiration, Artificial |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012151 | Resuscitation |
| D004638 | Emergency Treatment |
| D012138 | Respiratory Therapy |
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