Rate of Postoperative Delirium and Postoperative Cognitive Dysfunction After Spinal Anesthesia

Charité University Medicine Berlin

Status: Completed

Conditions: Delirium

Treatments: Procedure: General anesthesia (current standard); Procedure: Spinal anesthesia with short-acting local anesthetics

Study type: Observational

Funder types: Other

Identifiers

NCT03715244

PODSPA

Details and patient eligibility

About

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.

Full 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

Enrollment: 237 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

237 participants in 3 patient groups

Study group 1

Description:

n=220 patients for routine data of spinal anesthesia with short-acting local anesthetics

Treatment:

Procedure: Spinal anesthesia with short-acting local anesthetics

Study group 2

Description:

n= 220 patients for routine data of general anesthesia (current standard)

Treatment:

Procedure: General anesthesia (current standard)

No intervention: Control group postoperative cognitive deficit

Description:

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.