Rate of Postoperative Delirium and Postoperative Cognitive Dysfunction After Spinal Anesthesia

NCT ID: NCT03715244

Last Updated: 2022-09-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 237 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-12
• Study Completion Date: 2022-07-14

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.

Detailed 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

Conditions

Delirium

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study group 1

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

Spinal anesthesia with short-acting local anesthetics

Intervention Type: PROCEDURE

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

Study group 2

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

General anesthesia (current standard)

Intervention Type: PROCEDURE

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

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.

No interventions assigned to this group

Interventions

Spinal anesthesia with short-acting local anesthetics

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

Intervention Type: PROCEDURE

General anesthesia (current standard)

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• 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

• 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:

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Claudia Spies

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudia Spies, MD, Prof.

Role: STUDY_DIRECTOR

Charite University, Berlin, Germany

Locations

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

Berlin, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 28187050 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40945957 (View on PubMed)

Other Identifiers

PODSPA

Identifier Type: -

Identifier Source: org_study_id