Rate of Postoperative Delirium and Postoperative Cognitive Dysfunction After Spinal Anesthesia With Short-acting Local Anesthetics Compared to General Anesthesia After a Shared Decision Making Process
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Delirium
- Sponsor
- Charite University, Berlin, Germany
- Enrollment
- 237
- Locations
- 1
- Primary Endpoint
- Rate of postoperative delirium
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The aim of this investigation is to compare the standard of general anesthesia used in these patients with these short-acting local anesthetics (Chloroprocain (Ampres®) and Prilocain (Takipril®)) for spinal anesthesia as well as to report the patient centered outcome of postoperative delirium and neurocognitive disorder. In accordance to current evidence regarding the occurrence of postoperative delirium and postoperative cognitive deficit, patients are to be screened daily for delirium up to the fifth postoperative day if in hospital, or till the first postoperative day after ambulatory surgery and for neurocognitive disorder 1 year following the surgery. To detect delirium the Nu-DESC (Nursing Delirium Screening Scale) will be used as a validated scoring systems to ensure the highest sensitivity in delirium identification. CANTAB battery will be used for assessment of neurocognitive disorder. This is a neuropsychological testing (computer-based (I-Pad) [Cambridge Neuropsychological Test Automated Battery - CANTAB connect and parameters from the item list], as well as the subjective / by proxy Assessment of Cognitive Limitations. It is essential to perform the appropriate cognitive performance tests not only on operative patients but also on a non-surgical cohort, using currently established models of calculation in postoperative cognitive deficits and a control group generated from non-surgical patients.
Detailed Description
A conventional spinal anesthesia with long-acting drugs (such as bupivacaine) can lead to delays in postoperative recovery, mobilization, delays in discharge from recovery room and in ambulatory surgery. Short-acting local anesthetics (Chloroprocain (Ampres®) and Prilocain (Takipril®)) might be beneficial in short duration surgery under spinal anesthesia and could improve patients' acceptance for neuroaxial anesthesia as it might improve early recovery and early mobilization. Time to first oral nutritional intake/postoperative nausea and vomiting (PONV), time to discharge from post-anesthesia recovery unit and time to discharge home after ambulatory operation might be reduced and might reduce incidence of postoperative delirium and neurocognitive disorder after peripheral surgery. It is planned to retrospectively examine a group of surgical patients for the purpose of a comparative descriptive collective. This comparison collective is required for various questions, in particular influencing factors with regard to the postoperative outcomes delirium, neurocognitive disorder and mortality. Only the routine data is used and no additional surveys are performed on these patients. Inclusion criteria such as the study cohort and additionally the inclusion criterion: Spinal anesthesia with another local anesthetic
Investigators
Claudia Spies
Head of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - University Medicine Berlin
Charite University, Berlin, Germany
Eligibility Criteria
Inclusion Criteria
- •Surgical patients at Campus Virchow - Klinikum and Campus Charité Mitte (Charité - Universitätsmedizin Berlin)
- •Short, elective procedure (\<90 minutes), feasible in spinal anesthesia
- •American Society of Anesthesiologists (ASA-Score I to III)
- •Age ≥ 18 years
- •Informed consent process
Exclusion Criteria
- •Non-consenting patients
- •Lack of consent to participate in the study or to store, process and disseminate pseudonymised study data
- •Allergy or contraindications to local anesthetics
- •Contraindications to spinal anesthesia
- •Coagulopathy or therapy with anticoagulants
- •Higher grade aortic stenosis
- •Anomaly of the spinal cord
- •Pre-existing neurological deficit
- •Pre-existing neurological disease that severely limits the performance of neurocognitive testing
- •Hearing and / or visual disturbances (such as color blindness) or relevant language barrier severely limiting the performance of neurocognitive testing
Outcomes
Primary Outcomes
Rate of postoperative delirium
Time Frame: Up to five postoperative days
Postoperative delirum rate, defined according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V) and/or as ≥ 2 cumulative points in the nursing Delirium Screening Scale (Nu-DESC) and/or a positive Confusion Assessment Method (CAM) Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) score and/or patient chart review that shows descriptions of delirium. The basis is the elevation of the sedation depth with the Richmond Agitation Sedation Scale (RASS).
Secondary Outcomes
- Formal cognitive testing(Up to 1 year)
- Postoperative cognitive dysfunction (POCD)(Up to 1 year)
- Perioperative cognitive disturbances(Up to 1 year)
- Severity of delirium(Participants will be followed for the duration of hospital stay, an expected average of 7 days ])
- Time to first oral nutritional intake(Up to five postoperative days)
- Time until leaving the recovery room(Up to leaving the recovery room)
- Organ complications according to Clavien(Up to five postoperative days)
- Total treatment outcome in terms of quality of life of patients(Up to 1 year)
- Total treatment outcome in terms of functional autonomy of patients(Up to 1 year)
- Intraoperative Neuromonitoring(Up to the end of surgical procedure)
- Pro and anti-inflammatory markers(Until first postoperative day)
- Immune cells(Until first postoperative day)
- Fatigue(Up to 1 year)
- Sleep behavior(Participants will be followed for the duration of hospital stay, an expected average of 7 days ])
- Duration of concomitant medication(Up to 5 postoperative days)
- Number of stationary recoveries(Up to 1 year)
- Cholinesterases(Until the third postoperative day)
- Anxiety 1(Up to 1 year)
- Time of mechanical ventilation(Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day])
- MONTREAL COGNITIVE ASSESSMENT (MOCA)(Up to 1 year)
- Time until leaving hospital(Up to five postoperative days)
- Questionnaire for shared decision making (PEF-FB-9)(Up to five postoperative days)
- Apolipoprotein E(Until the end of surgery)
- Antibodies(Until first postoperative day)
- Autophagy of platelets(Until first postoperative day)
- Anxiety 2(Up to 1 year)
- Frailty(Participants will be measured at the beginning of the investigation.)
- Time to mobilization(Up to five postoperative days)
- Subsequent surgery(Up to 1 year)
- Obstructive Sleep Apnea (OSAS)(Up to 1 year)
- Stress(Up to 1 year)
- Dose of concomitant medication(Up to 5 postoperative days)
- Visits to doctors and outpatient treatments(Up to 1 year)
- Number of additional operations(Up to 1 year)
- Duration of delirium(Participants will be followed for the duration of hospital stay, an expected average of 7 days ])
- Autonomy Preference Index (API)(Up to five postoperative days)
- Cerobrospinal fluid parameter(Until the end of surgery)
- Multiplex Gene Expression Analysis (Whole Blood)(Until first postoperative day)
- Intracellular pH(Until first postoperative day)
- Intensive care unit stay(Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day])
- Mortality(Up to 1 year)