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Rate of Postoperative Delirium and Postoperative Cognitive Dysfunction After Spinal Anesthesia

NCT03715244 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 237

Last updated 2022-09-14

No results posted yet for this study

Summary

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.

Conditions

  • Delirium

Interventions

PROCEDURE

Spinal anesthesia with short-acting local anesthetics

Spinal anesthesia in patients with duration of surgery \< 90 minutes

PROCEDURE

General anesthesia (current standard)

General anesthesia in patients with duration of surgery \< 90 minutes

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Claudia Spies, MD, Prof. · Charite University, Berlin, Germany

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-12
Primary Completion
2021-11-09
Completion
2022-07-14

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03715244 on ClinicalTrials.gov