Rate of Postoperative Delirium and Postoperative Cognitive Dysfunction After Spinal Anesthesia

NCT03715244 | Completed

• 1 other identifier: PODSPA
• Study Type: observational
• Target: 237
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Rate of postoperative delirium

  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).

  Up to five postoperative days

Secondary Outcomes (42)

• Perioperative cognitive disturbances

  Up to 1 year

• MONTREAL COGNITIVE ASSESSMENT (MOCA)

  Up to 1 year

• Formal cognitive testing

  Up to 1 year

• Postoperative cognitive dysfunction (POCD)

  Up to 1 year

• Duration of delirium

  Participants will be followed for the duration of hospital stay, an expected average of 7 days ]

Study Arms (3)

Study group 1

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

Procedure: Spinal anesthesia with short-acting local anesthetics

Study group 2

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

Procedure: General anesthesia (current standard)

No intervention: Control group postoperative cognitive deficit

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.

Interventions

Spinal anesthesia with short-acting local anesthetics PROCEDURE

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

Study group 1

General anesthesia (current standard) PROCEDURE

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

Study group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Surgical patients at Campus Virchow - Klinikum and Campus Charité Mitte (Charité - Universitätsmedizin Berlin) with short, elective procedure (\<90 minutes), feasible in spinal anesthesia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

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

Berlin, 10117, Germany

Location

Related Publications (2)

• Aldecoa C, Bettelli G, Bilotta F, Sanders RD, Audisio R, Borozdina A, Cherubini A, Jones C, Kehlet H, MacLullich A, Radtke F, Riese F, Slooter AJ, Veyckemans F, Kramer S, Neuner B, Weiss B, Spies CD. European Society of Anaesthesiology evidence-based and consensus-based guideline on postoperative delirium. Eur J Anaesthesiol. 2017 Apr;34(4):192-214. doi: 10.1097/EJA.0000000000000594.

  PMID: 28187050 BACKGROUND

• Kipping V, Kerlin TB, Borchers F, Kulken MF, Schmid M, Ahrend CS, Wiebach J, Piper SK, Wernecke KD, Muller A, Spies CD. Postoperative delirium after short-acting spinal anesthesia and general anesthesia after shared decision-making. J Int Med Res. 2025 Sep;53(9):3000605251363408. doi: 10.1177/03000605251363408. Epub 2025 Sep 13.

  PMID: 40945957 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Apolipoprotein-E-4, ncounter Neuroinflammation and micro RNA Panel from Multiplex-Genexpressionsanalyses

MeSH Terms

Conditions

Delirium

Interventions

Anesthesia, Spinal; Anesthesia, General

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Claudia Spies, MD, Prof.

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - University Medicine Berlin

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 23, 2018
• Study Start: March 12, 2019
• Primary Completion: November 9, 2021
• Study Completion: July 14, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)