Fraily, Abdominal Surgery, Postoperative Cognitive Dysfunction (POCD)
Conditions
Keywords
neuraxial anesthesia, awake surgery, frailty, postoperative delirium, cognitive outcomes, perioperative medicine, enhanced recovery after surgery
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.
Interventions
PROCEDURENeuraxial anesthesia
patients undergo surgery with a neuraxial anesthesia based on spinal or epidural anesthesia using local anesthetics combined with sedation.
PROCEDUREGeneral Anesthesia
patients undergo surgery with a general anesthesia using classical GABAergic-drugs.
DRUGavoidance of GABAergic-drugs strategy
Sedation based on dexmedetomidine and low dosage of ketamine, avoiding GABAergic-drugs
DRUGuse of GABAergic-drugs
General anesthesia using classical GABAergic-drugs such as propofol, remifentanil and rocuronium.
PROCEDUREmechanical ventilation (MV)
Abdomino-pelvic Surgery managed in general anesthesia needs orotracheal intubation and mechanical ventilation
Sponsors
Ente Ospedaliero Ospedali Galliera
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
This is a bicentric, prospective, randomized, parallel-group study.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients effectively managed with neuraxial approach | Periprocedural | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative cognitive disfunction | The moment of enrollement and at 30 days follow-up and one year. | 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. |
| Postoperative delirium. | The moment of enrollement, post operative 0,1,2,3 and day of discharge. | 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. |
| Polmonary complications. | The moment of enrollement, postoperative days 1,2,3. | 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. |
| Renal function | Day of enrollement, postoperative days 1,2,3. | Postoperative renal function is assessed using the KDIGO score, where 1 represents mild renal insufficiency and 3 represents severe renal insufficiency. |
| In hospital lenght of stay | day of discharge (up to 1 month) | Lenght of stay (n° days) |
| Complications | up to 30 days and 1 year | Occurence of short-and medium-term postoperative complications (Clavien -Dindo classification from grade 1 to grade 5). |
| Recovery after surgery | From date of randomization until the date of first documented progression, assessed up to 1 month. | Day to recovery of oral intake (n°) Day to first mobilization (n°) These outcomes aim to evaluate the overall impact to ERAS principles. |
| Renal arterial perfusion | Day of enrollment, postoperative days 1,2,3 | Renal Doppler ultrasound is also performed, calculating the renal resistance index, which is normally \<0.7 (range 0-1) |
| Renal congestion | day of enrollment, postoperative days 1,2,3 | Renal Doppler ultrasound is also performed to assess venous congestion index, which is normally 0 (range 0-1). |
Countries
Italy
Contacts
CONTACTClaudia Brusasco, MD, PhD
Outcome results
None listed