- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03715244
Rate of Postoperative Delirium and Postoperative Cognitive Dysfunction After Spinal Anesthesia
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
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Berlin, Germany, 10117
- Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Study group 1 and 2
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
- 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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Study group 1
n=220 patients for routine data of 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)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Up to five postoperative days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perioperative cognitive disturbances
Time Frame: Up to 1 year
|
Cognitive disorders are evaluated according to DSM-V (formal cognitive testing, subjective memory sensing and instrumental activities of daily living, ).
|
Up to 1 year
|
MONTREAL COGNITIVE ASSESSMENT (MOCA)
Time Frame: Up to 1 year
|
Test performance of the MONTREAL COGNITIVE ASSESSMENT (MOCA) for screening of dementia
|
Up to 1 year
|
Formal cognitive testing
Time Frame: Up to 1 year
|
Perioperative changes of damain specific test performance in formal cognitive testing
|
Up to 1 year
|
Postoperative cognitive dysfunction (POCD)
Time Frame: 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.
|
Up to 1 year
|
Duration of delirium
Time Frame: 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
|
Participants will be followed for the duration of hospital stay, an expected average of 7 days ]
|
Severity of delirium
Time Frame: 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
|
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
|
Up to five postoperative days
|
|
Time to first oral nutritional intake
Time Frame: Up to five postoperative days
|
Up to five postoperative days
|
|
Time until leaving the recovery room
Time Frame: Up to leaving the recovery room
|
Fulfillment of discharge criteria from the recovery room
|
Up to leaving the recovery room
|
Time until leaving hospital
Time Frame: Up to five postoperative days
|
Fulfillment of discharge criteria from hospital after study procedure
|
Up to five postoperative days
|
Organ complications according to Clavien
Time Frame: Up to five postoperative days
|
Up to five postoperative days
|
|
Autonomy Preference Index (API)
Time Frame: Up to five postoperative days
|
Up to five postoperative days
|
|
Questionnaire for shared decision making (PEF-FB-9)
Time Frame: Up to five postoperative days
|
Results from PEF-FB-9 are evaluated
|
Up to five postoperative days
|
Total treatment outcome in terms of quality of life of patients
Time Frame: Up to 1 year
|
EQ-5D
|
Up to 1 year
|
Total treatment outcome in terms of functional autonomy of patients
Time Frame: Up to 1 year
|
Activities of Daily Living (ADLs) or Instrumental Activities of Daily Living (IADLs)
|
Up to 1 year
|
Intraoperative Neuromonitoring
Time Frame: Up to the end of surgical procedure
|
Up to the end of surgical procedure
|
|
Cerobrospinal fluid parameter
Time Frame: 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
|
Until the end of surgery
|
Apolipoprotein E
Time Frame: Until the end of surgery
|
Blood marker Apolipoprotein E for measuring dementia
|
Until the end of surgery
|
Multiplex Gene Expression Analysis (Whole Blood)
Time Frame: Until first postoperative day
|
Until first postoperative day
|
|
Antibodies
Time Frame: Until first postoperative day
|
Antibody from serum (anti-beta2-adrenergic receptor, anti-muscarinic acetylcholine receptor (M3 / M4), anti-serotonin receptor, anti-dopamine receptor)
|
Until first postoperative day
|
Pro and anti-inflammatory markers
Time Frame: Until first postoperative day
|
IL-8 from whole blood and IL-6, IL-8 and TGF
|
Until first postoperative day
|
Immune cells
Time Frame: Until first postoperative day
|
Immune cells from citrate blood
|
Until first postoperative day
|
Autophagy of platelets
Time Frame: Until first postoperative day
|
Autophagy of platelets from citrate blood
|
Until first postoperative day
|
Intracellular pH
Time Frame: Until first postoperative day
|
Intracellular pH from citrate blood
|
Until first postoperative day
|
Cholinesterases
Time Frame: Until the third postoperative day
|
Until the third postoperative day
|
|
Anxiety 1
Time Frame: Up to 1 year
|
Anxiety 1 is measured by Generalized Anxiety Disorder 7 (GAD-7) and Patient Health Questionnaire 9 (PHQ-9)
|
Up to 1 year
|
Anxiety 2
Time Frame: Up to 1 year
|
Anxiety 2 is measured by Amsterdam Preoperative Anxiety and Information Scale (APAIS) and Faces Anxiety Scale (FAS)
|
Up to 1 year
|
Subsequent surgery
Time Frame: Up to 1 year
|
Results from subsequent surgery are evaluated
|
Up to 1 year
|
Obstructive Sleep Apnea (OSAS)
Time Frame: Up to 1 year
|
Obstructive Sleep Apnea (OSAS) is measured by the STOP-Bang Questionnaire.
|
Up to 1 year
|
Fatigue
Time Frame: Up to 1 year
|
Fatigue is monitored by Acute Fatigue Score
|
Up to 1 year
|
Sleep behavior
Time Frame: Up to 1 year
|
Sleep behaviour is measured by Insomnia Severity Index (ISI) at baseline, 3 months, 1 year
|
Up to 1 year
|
Sleep behavior
Time Frame: 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)
|
Participants will be followed for the duration of hospital stay, an expected average of 7 days ]
|
Frailty
Time Frame: 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
|
Participants will be measured at the beginning of the investigation.
|
Stress
Time Frame: Up to 1 year
|
Stress is monitored by Perceived Stress Questionnaire 20 (PSQ20) and Disstressthermometer without areas
|
Up to 1 year
|
Dose of concomitant medication
Time Frame: Up to 5 postoperative days
|
The types of medications used in the management of pain, agitation, and delirium on that day are documented.
|
Up to 5 postoperative days
|
Duration of concomitant medication
Time Frame: Up to 5 postoperative days
|
The types of medications used in the management of pain, agitation, and delirium on that day are documented.
|
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]
|
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]
|
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
|
Up to 1 year
|
|
Visits to doctors and outpatient treatments
Time Frame: Up to 1 year
|
Up to 1 year
|
|
Number of additional operations
Time Frame: Up to 1 year
|
Up to 1 year
|
|
Mortality
Time Frame: Up to 1 year
|
Up to 1 year
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Postoperative Complications
- Neurologic Manifestations
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Cognition Disorders
- Delirium
- Cognitive Dysfunction
- Postoperative Cognitive Complications
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
Other Study ID Numbers
- PODSPA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Delirium
-
Efficacy Care R&D LtdHadassah Medical OrganizationUnknownDelirium | Delirium, Cause Unknown | Delirium of Mixed Origin | Delirium Confusional State | Delirium Drug-InducedIsrael
-
Imperial College Healthcare NHS TrustRecruitingCardiac Surgery | Intensive Care Unit Delirium | Post Operative DeliriumUnited Kingdom
-
Oslo University HospitalUniversity of Melbourne; Norwegian Academy of MusicRecruitingDelirium in Old Age | Delirium of Mixed Origin | Delirium Superimposed on Dementia | Delirium Confusional StateNorway
-
Menoufia UniversityCompleted
-
Universidad de SantanderUnknownDelirium of Mixed Origin | Hypoactive Delirium | Hyperactive DeliriumColombia
-
Johns Hopkins UniversityNational Institute on Aging (NIA)Active, not recruitingDelirium | Delirium on Emergence | Hearing Loss | Hearing Loss, High-Frequency | Hearing Loss, Sensorineural | Delirium, Cause Unknown | Hearing Loss, Bilateral | Hearing Disability | Delirium in Old Age | Delirium of Mixed Origin | Delirium Superimposed on Dementia | Delirium Confusional State | Delirium With... and other conditionsUnited States
-
Chinese PLA General HospitalBeijing Tiantan HospitalRecruiting
-
Charite University, Berlin, GermanyBARMERRecruitingDelirium in Old AgeGermany
-
Mayo ClinicCompletedPost-Operative DeliriumUnited States
-
University Hospital, Basel, SwitzerlandInnosuisse - Swiss Innovation AgencyRecruitingPostoperative Delirium (POD)Switzerland
Clinical Trials on Spinal anesthesia with short-acting local anesthetics
-
Sahlgrenska University Hospital, SwedenCompleted
-
Ain Shams UniversityRecruiting
-
Campus Bio-Medico UniversityCompleted
-
Fraser HealthNot yet recruitingAnesthesia, Spinal | Neurosurgery | Ropivacaine | BupivacaineCanada
-
Milton S. Hershey Medical CenterRecruitingLeft Ventricular Dysfunction | Spinal Anesthetics Causing Adverse Effects in Therapeutic Use | Global Cardiac Wall Motion DysfunctionUnited States
-
CMC Ambroise ParéCompleted
-
Pontificia Universidade Catolica de Sao PauloCompletedQuality of Life | Pain, Postoperative | Postoperative Complication | Personal SatisfactionBrazil
-
Instituto Materno Infantil Prof. Fernando FigueiraCompletedPyrexia | Abdominal Delivery
-
Bakirkoy Dr. Sadi Konuk Research and Training HospitalCompletedPregnancy Related | Regional Anesthesia Morbidity | Postdural Puncture HeadacheTurkey
-
CHU de ReimsCompleted