Rate of Postoperative Delirium and Postoperative Cognitive Dysfunction After Spinal Anesthesia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Study group 1 n=220 patients for routine data of spinal anesthesia with short-acting local anesthetics |
Procedure: Spinal anesthesia with short-acting local anesthetics
Spinal anesthesia in patients with duration of surgery < 90 minutes
|
| Study group 2 n= 220 patients for routine data of general anesthesia (current standard) |
Procedure: General anesthesia (current standard)
General anesthesia in patients with duration of surgery < 90 minutes
|
| No intervention: Control group postoperative cognitive deficit n= 90 control subjects aged 18 years or older (without surgery) with a similar health status and age as the study group patients (similar distribution in the American Society of Anaesthesiologists physical status classification and relevant co-morbidities, e.g. diabetes, coronary artery disease, hypertension and hyperlipidemia). The patients are analyzed to correct for learning effects of the cognitive assessment testings in the study groups. |
Outcome Measures
Primary Outcome Measures
- Rate of postoperative delirium [Up to five postoperative days]
Postoperative delirium 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) and/or 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
- 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, ).
- MONTREAL COGNITIVE ASSESSMENT (MOCA) [Up to 1 year]
Test performance of the MONTREAL COGNITIVE ASSESSMENT (MOCA) for screening of dementia
- 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.
- 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) Intensive Care Delirium Screening Checklist (ICDSC) Delirium Detection Scale (DDS) Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) Confusion Assessment Method (CAM) Chart Review
- 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) Intensive Care Delirium Screening Checklist (ICDSC) Delirium Detection Scale (DDS) Confusion Assessment Method (CAM) Chart Review
- Time to mobilization [Up to five postoperative days]
- 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
- Time until leaving hospital [Up to five postoperative days]
Fulfillment of discharge criteria from hospital after study procedure
- Organ complications according to Clavien [Up to five postoperative days]
- Autonomy Preference Index (API) [Up to five postoperative days]
- Perceived involvement in care scales (PICS) [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]
- 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
- Apolipoprotein E [Until the end of surgery]
Blood marker Apolipoprotein E for measuring dementia
- Multiplex Gene Expression Analysis (Whole Blood) [Until first postoperative day]
- Antibodies [Until first postoperative day]
Antibody from serum (anti-beta2-adrenergic receptor, anti-muscarinic acetylcholine receptor (M3 / M4), anti-serotonin receptor, anti-dopamine receptor)
- 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
- Autophagy of platelets [Until first postoperative day]
Autophagy of platelets from citrate blood
- Intracellular pH [Until first postoperative day]
Intracellular pH from citrate blood
- Cholinesterases [Until the third postoperative day]
- Anxiety [Up to 1 year]
Anxiety is measured by Generalized Anxiety Disorder 7 (GAD-7) and Patient Health Questionnaire 9 (PHQ-9)
- Anxiety [Up to 1 year]
Anxiety is measured by Amsterdam Preoperative Anxiety and Information Scale (APAIS) and Faces Anxiety Scale (FAS)
- Patient records from Memory clinic [Up to 1 year]
Results from memory consultation session are evaluated
- Obstructive Sleep Apnea (OSAS) [Up to 1 year]
Obstructive Sleep Apnea (OSAS) is measured by the STOP-Bang Questionnaire.
- Fatigue [Up to 1 year]
Fatigue is monitored by Acute Fatigue Score
- Sleep behavior [Up to 1 year]
Sleep behaviour is measured by Insomnia Severity Index (ISI) and 2 items from the Pittsburgh Sleep Quality Index (PSQI): "How would you describe the overall quality of your sleep during the last 6 months" (modified Item 6) and how often do you have sleep aids during the last four weeks taken; Which sleeping aid you have taken (Item 7); at baseline, 3 months, 1 year
- 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)
- Frailty [Participants will be followed for the duration of hospital stay, an expected average of 7 days]
Frailty is measured with a modified frailty score according to Fried´s frailty phenotype assessment
- 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.
- 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.
- Time of mechanical ventilation [Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day]]
- Intensive care unit stay [Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day]]
- Number of stationary recoveries [Up to 1 year]
- Visits to doctors and outpatient treatments [Up to 1 year]
- Number of additional operations [Up to 1 year]
- Mortality [Up to 1 year]
Eligibility Criteria
Criteria
Study group 1 and 2
Inclusion Criteria:
-
Surgical patients at Campus Virchow - Klinikum and Campus Charité Mitte (Charité - Universitätsmedizin Berlin)
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Short, elective procedure (<90 minutes), feasible in spinal anesthesia
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American Society of Anesthesiologists (ASA-Score I to III)
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Age ≥ 18 years
-
Informed consent process
Exclusion Criteria:
-
Non-consenting patients
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Lack of consent to participate in the study or to store, process and disseminate pseudonymised study data
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Allergy or contraindications to local anesthetics
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Contraindications to spinal anesthesia
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Coagulopathy or therapy with anticoagulants
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Higher grade aortic stenosis
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Anomaly of the spinal cord
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Pre-existing neurological deficit
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Pre-existing neurological disease that severely limits the performance of neurocognitive testing
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Hearing and / or visual disturbances (such as color blindness) or relevant language barrier severely limiting the performance of neurocognitive testing
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Spinal anesthesia with another local anesthetic
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Sole peripheral local anesthesia
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Participation in another prospective intervention study
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Emergency operation
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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)
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Healthy volunteers (ASA I) / ASA II + III patients who are not scheduled for surgery next year
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Ability to consent to oral and written information
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Patient education and written consent
Exclusion criteria:
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Operation in the last six months before inclusion in this study
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Lack of consent for the pseudonymised disease data to be stored and shared in this clinical trial
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Lack of readiness to participate in the follow-up examinations and contact to make an appointment
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Patients with a neuropsychiatric condition that limits the performance of neurocognitive testing
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Patients with hearing and / or vision disorders or relevant language barriers that limit the performance of neuro-cognitive testing
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Simultaneous participation in a prospective clinical intervention study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin | Berlin | Germany | 10117 |
Sponsors and Collaborators
- Charite University, Berlin, Germany
Investigators
- Study Director: Claudia Spies, MD, Prof., Charite University, Berlin, Germany
Study Documents (Full-Text)
None provided.More Information
Publications
- PODSPA