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.
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
Study Type
OBSERVATIONAL
Enrollment
237
Spinal anesthesia in patients with duration of surgery \< 90 minutes
General anesthesia in patients with duration of surgery \< 90 minutes
Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin
Berlin, Germany
Rate of postoperative delirium
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).
Time frame: Up to five postoperative days
Perioperative cognitive disturbances
Cognitive disorders are evaluated according to DSM-V (formal cognitive testing, subjective memory sensing and instrumental activities of daily living, ).
Time frame: Up to 1 year
MONTREAL COGNITIVE ASSESSMENT (MOCA)
Test performance of the MONTREAL COGNITIVE ASSESSMENT (MOCA) for screening of dementia
Time frame: Up to 1 year
Formal cognitive testing
Perioperative changes of damain specific test performance in formal cognitive testing
Time frame: Up to 1 year
Postoperative cognitive dysfunction (POCD)
Postoperative cognitive dysfunction (POCD) is measured by computerized Cambridge Neuropsychological Test Automated Battery - CANTAB connect and paper pencil testing and subjective memory sensing.
Time frame: Up to 1 year
Duration of delirium
Diagnostic and Statistical Manual of Mental Disorders (DSM-V) Nursing Delirium Screening Scale (Nu-DESC) Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) Confusion Assessment Method (CAM) Chart Review
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ]
Severity of delirium
Diagnostic and Statistical Manual of Mental Disorders (DSM-V) Nursing Delirium Screening Scale (Nu-DESC), Confusion Assessment Method (CAM) and or Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), Chart Review
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ]
Time to mobilization
Time frame: Up to five postoperative days
Time to first oral nutritional intake
Time frame: Up to five postoperative days
Time until leaving the recovery room
Fulfillment of discharge criteria from the recovery room
Time frame: Up to leaving the recovery room
Time until leaving hospital
Fulfillment of discharge criteria from hospital after study procedure
Time frame: Up to five postoperative days
Organ complications according to Clavien
Time frame: Up to five postoperative days
Autonomy Preference Index (API)
Time frame: Up to five postoperative days
Questionnaire for shared decision making (PEF-FB-9)
Results from PEF-FB-9 are evaluated
Time frame: Up to five postoperative days
Total treatment outcome in terms of quality of life of patients
EQ-5D
Time frame: Up to 1 year
Total treatment outcome in terms of functional autonomy of patients
Activities of Daily Living (ADLs) or Instrumental Activities of Daily Living (IADLs)
Time frame: Up to 1 year
Intraoperative Neuromonitoring
Time frame: Up to the end of surgical procedure
Cerobrospinal fluid parameter
Beta-Amyloid 1-40, beta-Amyloid 1-42, beta-Amyloid Ratio (42/40\*10), phospho-TAU, Protein 14-3-3, PRPSc, TAU (Gesamt-Tau) from cerobrospinal fluid for measuring dementia
Time frame: Until the end of surgery
Apolipoprotein E
Blood marker Apolipoprotein E for measuring dementia
Time frame: Until the end of surgery
Multiplex Gene Expression Analysis (Whole Blood)
Time frame: Until first postoperative day
Antibodies
Antibody from serum (anti-beta2-adrenergic receptor, anti-muscarinic acetylcholine receptor (M3 / M4), anti-serotonin receptor, anti-dopamine receptor)
Time frame: Until first postoperative day
Pro and anti-inflammatory markers
IL-8 from whole blood and IL-6, IL-8 and TGF
Time frame: Until first postoperative day
Immune cells
Immune cells from citrate blood
Time frame: Until first postoperative day
Autophagy of platelets
Autophagy of platelets from citrate blood
Time frame: Until first postoperative day
Intracellular pH
Intracellular pH from citrate blood
Time frame: Until first postoperative day
Cholinesterases
Time frame: Until the third postoperative day
Anxiety 1
Anxiety 1 is measured by Generalized Anxiety Disorder 7 (GAD-7) and Patient Health Questionnaire 9 (PHQ-9)
Time frame: Up to 1 year
Anxiety 2
Anxiety 2 is measured by Amsterdam Preoperative Anxiety and Information Scale (APAIS) and Faces Anxiety Scale (FAS)
Time frame: Up to 1 year
Subsequent surgery
Results from subsequent surgery are evaluated
Time frame: Up to 1 year
Obstructive Sleep Apnea (OSAS)
Obstructive Sleep Apnea (OSAS) is measured by the STOP-Bang Questionnaire.
Time frame: Up to 1 year
Fatigue
Fatigue is monitored by Acute Fatigue Score
Time frame: Up to 1 year
Sleep behavior
Sleep behaviour is measured by Insomnia Severity Index (ISI) at baseline, 3 months, 1 year
Time frame: Up to 1 year
Sleep behavior
Sleep behaviour is measured by intraclinical course (immediate perioperative: Richards Campbell Sleep Questionnaire)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ]
Frailty
Frailty is measured with a modified frailty score according to Fried´s frailty phenotype assessment
Time frame: Participants will be measured at the beginning of the investigation.
Stress
Stress is monitored by Perceived Stress Questionnaire 20 (PSQ20) and Disstressthermometer without areas
Time frame: Up to 1 year
Dose of concomitant medication
The types of medications used in the management of pain, agitation, and delirium on that day are documented.
Time frame: Up to 5 postoperative days
Duration of concomitant medication
The types of medications used in the management of pain, agitation, and delirium on that day are documented.
Time frame: Up to 5 postoperative days
Time of mechanical ventilation
Time frame: Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day]
Intensive care unit stay
Time frame: Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day]
Number of stationary recoveries
Time frame: Up to 1 year
Visits to doctors and outpatient treatments
Time frame: Up to 1 year
Number of additional operations
Time frame: Up to 1 year
Mortality
Time frame: Up to 1 year
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