Spinal Anestezi Sonrası Ameliyat Sonrası Deliryum ve Bilişsel İşlev Bozukluğu Oranı

Sade dilde özet

Bu çalışma, spinal anestezi ile ameliyat edilen hastalarda ameliyat sonrası deliryum ve ameliyat sonrası bilişsel işlev bozukluğu (postoperative cognitive dysfunction) sıklığını, genel anesteziyle karşılaştırarak inceliyor. Kısa süreli, planlı bir ameliyat geçiren, 18 yaş ve üzeri hastalar katılabiliyor. Çalışma faz uygulanmayan bir çalışma olarak yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

N/A

Durum

Tamamlandı

Sponsor

Charite University, Berlin, Germany

Müdahale

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

Başlangıç

12.03.2019

Tahmini bitiş

14.07.2022

Ülkeler

Germany

İlgili genler

Merkezler

• Berlin, Germany

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

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