Rate of Postoperative Delirium and Postoperative Cognitive Dysfunction After Spinal Anesthesia

Plain-language summary

This study examines the frequency of postoperative delirium and postoperative cognitive dysfunction in patients operated on under spinal anesthesia, comparing it with general anesthesia. Patients aged 18 and over undergoing a short, elective procedure may take part. It is a study without an assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

Charite University, Berlin, Germany

Intervention

Spinal anesthesia with short-acting local anesthetics, General anesthesia (current standard)

Start date

3/12/2019

Estimated completion

7/14/2022

Countries

Germany

Related genes

Locations

• Berlin, Germany

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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