Rate of Postoperative Delirium and Postoperative Cognitive Dysfunction After Spinal Anesthesia
- Conditions
- Delirium
- Interventions
- Procedure: Spinal anesthesia with short-acting local anestheticsProcedure: General anesthesia (current standard)
- Registration Number
- NCT03715244
- Lead Sponsor
- Charite University, Berlin, Germany
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 237
- 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
- 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
- Spinal anesthesia with another local anesthetic
- Sole peripheral local anesthesia
- Participation in another prospective intervention study
- Emergency operation
- Pregnancy and breast feeding period
POCD Control group:
Inclusion criteria:
- Male and female patients ages 18-100 years, also controls from the POCD registry (EA1/104/16)
- Healthy volunteers (ASA I) / ASA II + III patients who are not scheduled for surgery next year
- Ability to consent to oral and written information
- Patient education and written consent
Exclusion criteria:
- Operation in the last six months before inclusion in this study
- Lack of consent for the pseudonymised disease data to be stored and shared in this clinical trial
- Lack of readiness to participate in the follow-up examinations and contact to make an appointment
- Patients with a neuropsychiatric condition that limits the performance of neurocognitive testing
- Patients with hearing and / or vision disorders or relevant language barriers that limit the performance of neuro-cognitive testing
- Simultaneous participation in a prospective clinical intervention study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Study group 1 Spinal anesthesia with short-acting local anesthetics n=220 patients for routine data of spinal anesthesia with short-acting local anesthetics Study group 2 General anesthesia (current standard) n= 220 patients for routine data of general anesthesia (current standard)
- Primary Outcome Measures
Name Time Method Rate of postoperative delirium 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 Outcome Measures
Name Time Method Visits to doctors and outpatient treatments Up to 1 year Number of additional operations Up to 1 year Formal cognitive testing Up to 1 year Perioperative changes of damain specific test performance in formal cognitive testing
Postoperative cognitive dysfunction (POCD) Up to 1 year Postoperative cognitive dysfunction (POCD) is measured by computerized Cambridge Neuropsychological Test Automated Battery - CANTAB connect and paper pencil testing and subjective memory sensing.
Perioperative cognitive disturbances Up to 1 year Cognitive disorders are evaluated according to DSM-V (formal cognitive testing, subjective memory sensing and instrumental activities of daily living, ).
Severity of delirium Participants will be followed for the duration of hospital stay, an expected average of 7 days ] 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 to first oral nutritional intake Up to five postoperative days Time until leaving the recovery room Up to leaving the recovery room Fulfillment of discharge criteria from 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 EQ-5D
Total treatment outcome in terms of functional autonomy of patients Up to 1 year Activities of Daily Living (ADLs) or Instrumental Activities of Daily Living (IADLs)
Intraoperative Neuromonitoring Up to the end of surgical procedure Pro and anti-inflammatory markers Until first postoperative day IL-8 from whole blood and IL-6, IL-8 and TGF
Immune cells Until first postoperative day Immune cells from citrate blood
Fatigue Up to 1 year Fatigue is monitored by Acute Fatigue Score
Sleep behavior Participants will be followed for the duration of hospital stay, an expected average of 7 days ] Sleep behaviour is measured by intraclinical course (immediate perioperative: Richards Campbell Sleep Questionnaire)
Duration of concomitant medication Up to 5 postoperative days The types of medications used in the management of pain, agitation, and delirium on that day are documented.
Number of stationary recoveries 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] Cholinesterases Until the third postoperative day Anxiety 1 Up to 1 year Anxiety 1 is measured by Generalized Anxiety Disorder 7 (GAD-7) and Patient Health Questionnaire 9 (PHQ-9)
Stress Up to 1 year Stress is monitored by Perceived Stress Questionnaire 20 (PSQ20) and Disstressthermometer without areas
Dose of concomitant medication Up to 5 postoperative days The types of medications used in the management of pain, agitation, and delirium on that day are documented.
MONTREAL COGNITIVE ASSESSMENT (MOCA) Up to 1 year Test performance of the MONTREAL COGNITIVE ASSESSMENT (MOCA) for screening of dementia
Time until leaving hospital Up to five postoperative days Fulfillment of discharge criteria from hospital after study procedure
Questionnaire for shared decision making (PEF-FB-9) Up to five postoperative days Results from PEF-FB-9 are evaluated
Apolipoprotein E Until the end of surgery Blood marker Apolipoprotein E for measuring dementia
Antibodies Until first postoperative day Antibody from serum (anti-beta2-adrenergic receptor, anti-muscarinic acetylcholine receptor (M3 / M4), anti-serotonin receptor, anti-dopamine receptor)
Autophagy of platelets Until first postoperative day Autophagy of platelets from citrate blood
Anxiety 2 Up to 1 year Anxiety 2 is measured by Amsterdam Preoperative Anxiety and Information Scale (APAIS) and Faces Anxiety Scale (FAS)
Frailty Participants will be measured at the beginning of the investigation. Frailty is measured with a modified frailty score according to Fried´s frailty phenotype assessment
Time to mobilization Up to five postoperative days Subsequent surgery Up to 1 year Results from subsequent surgery are evaluated
Obstructive Sleep Apnea (OSAS) Up to 1 year Obstructive Sleep Apnea (OSAS) is measured by the STOP-Bang Questionnaire.
Duration of delirium Participants will be followed for the duration of hospital stay, an expected average of 7 days ] 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
Autonomy Preference Index (API) Up to five postoperative days Cerobrospinal fluid parameter Until the end of surgery 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
Multiplex Gene Expression Analysis (Whole Blood) Until first postoperative day Intracellular pH Until first postoperative day Intracellular pH from citrate blood
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
Trial Locations
- Locations (1)
Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany