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Completed

NCT Number: NCT03715244

Rate of Postoperative Delirium and Postoperative Cognitive Dysfunction After Spinal Anesthesia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal anesthesia with short-acting local anesthetics

Procedure

Spinal anesthesia in patients with duration of surgery < 90 minutes

General anesthesia (current standard)

Procedure

General anesthesia in patients with duration of surgery < 90 minutes

Primary outcomes

  1. 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

  1. 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, ).

  2. MONTREAL COGNITIVE ASSESSMENT (MOCA)

    Time frame: Up to 1 year

    Test performance of the MONTREAL COGNITIVE ASSESSMENT (MOCA) for screening of dementia

  3. Formal cognitive testing

    Time frame: Up to 1 year

    Perioperative changes of damain specific test performance in formal cognitive testing

  4. 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.

  5. 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

  6. 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

  7. Time to mobilization

    Time frame: Up to five postoperative days

  8. Time to first oral nutritional intake

    Time frame: Up to five postoperative days

  9. Time until leaving the recovery room

    Time frame: Up to leaving the recovery room

    Fulfillment of discharge criteria from the recovery room

  10. Time until leaving hospital

    Time frame: Up to five postoperative days

    Fulfillment of discharge criteria from hospital after study procedure

  11. Organ complications according to Clavien

    Time frame: Up to five postoperative days

  12. Autonomy Preference Index (API)

    Time frame: Up to five postoperative days

  13. Questionnaire for shared decision making (PEF-FB-9)

    Time frame: Up to five postoperative days

    Results from PEF-FB-9 are evaluated

  14. Total treatment outcome in terms of quality of life of patients

    Time frame: Up to 1 year

    EQ-5D

  15. 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)

  16. Intraoperative Neuromonitoring

    Time frame: Up to the end of surgical procedure

  17. 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

  18. Apolipoprotein E

    Time frame: Until the end of surgery

    Blood marker Apolipoprotein E for measuring dementia

  19. Multiplex Gene Expression Analysis (Whole Blood)

    Time frame: Until first postoperative day

  20. 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)

  21. Pro and anti-inflammatory markers

    Time frame: Until first postoperative day

    IL-8 from whole blood and IL-6, IL-8 and TGF

  22. Immune cells

    Time frame: Until first postoperative day

    Immune cells from citrate blood

  23. Autophagy of platelets

    Time frame: Until first postoperative day

    Autophagy of platelets from citrate blood

  24. Intracellular pH

    Time frame: Until first postoperative day

    Intracellular pH from citrate blood

  25. Cholinesterases

    Time frame: Until the third postoperative day

  26. 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)

  27. 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)

  28. Subsequent surgery

    Time frame: Up to 1 year

    Results from subsequent surgery are evaluated

  29. Obstructive Sleep Apnea (OSAS)

    Time frame: Up to 1 year

    Obstructive Sleep Apnea (OSAS) is measured by the STOP-Bang Questionnaire.

  30. Fatigue

    Time frame: Up to 1 year

    Fatigue is monitored by Acute Fatigue Score

  31. Sleep behavior

    Time frame: Up to 1 year

    Sleep behaviour is measured by Insomnia Severity Index (ISI) at baseline, 3 months, 1 year

  32. 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)

  33. 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

  34. Stress

    Time frame: Up to 1 year

    Stress is monitored by Perceived Stress Questionnaire 20 (PSQ20) and Disstressthermometer without areas

  35. 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.

  36. 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.

  37. Time of mechanical ventilation

    Time frame: Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day]

  38. Intensive care unit stay

    Time frame: Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day]

  39. Number of stationary recoveries

    Time frame: Up to 1 year

  40. Visits to doctors and outpatient treatments

    Time frame: Up to 1 year

  41. Number of additional operations

    Time frame: Up to 1 year

  42. Mortality

    Time frame: Up to 1 year

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Oct 23, 2018
Registry last updated
Sep 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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