DeliriumNCT03715244
Rate of Postoperative Delirium and Postoperative Cognitive Dysfunction After Spinal Anesthesia
An observational study of Delirium, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium
- What is being tested?
- Spinal anesthesia with short-acting local anesthetics and General anesthesia (current standard)
- Type of treatment
- Surgery or procedure
- How many people
- 237 participants
- Where
- 1 siteGermany
- Study dates
- 12 Mar 2019to 14 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin
Berlin, 10117
About this study
Official title: Rate of Postoperative Delirium and Postoperative Cognitive Dysfunction After Spinal Anesthesia With Short-acting Local Anesthetics Compared to General Anesthesia After a Shared Decision Making Process
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.
Read the 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
- Being tested
- Spinal anesthesia with short-acting local anesthetics, General anesthesia (current standard)
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesia with short-acting local anestheticsProcedure or surgery
Spinal anesthesia in patients with duration of surgery < 90 minutes
General anesthesia (current standard)Procedure or surgery
General anesthesia in patients with duration of surgery < 90 minutes
| Study group | Role | What they receive |
|---|---|---|
| Study group 1 | n=220 patients for routine data of spinal anesthesia with short-acting local anesthetics Receives: Procedure: Spinal anesthesia with short-acting local anesthetics | |
| Study group 2 | n= 220 patients for routine data of general anesthesia (current standard) Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to five postoperative days
Secondary outcomes (42)
Perioperative cognitive disturbances
Cognitive disorders are evaluated according to DSM-V (formal cognitive testing, subjective memory sensing and instrumental activities of daily living, ).
Measured: Up to 1 year
MONTREAL COGNITIVE ASSESSMENT (MOCA)
Test performance of the MONTREAL COGNITIVE ASSESSMENT (MOCA) for screening of dementia
Measured: Up to 1 year
Formal cognitive testing
Perioperative changes of damain specific test performance in formal cognitive testing
Measured: Up to 1 year
Postoperative cognitive dysfunction (POCD)
Postoperative cognitive dysfunction (POCD) is measured by computerized Cambridge Neuropsychological Test Automated Battery - CANTAB connect and paper pencil testing and subjective memory sensing.
Measured: Up to 1 year
Duration of delirium
Diagnostic and Statistical Manual of Mental Disorders (DSM-V) Nursing Delirium Screening Scale (Nu-DESC) Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) Confusion Assessment Method (CAM) Chart Review
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days ]
Severity of delirium
Diagnostic and Statistical Manual of Mental Disorders (DSM-V) Nursing Delirium Screening Scale (Nu-DESC), Confusion Assessment Method (CAM) and or Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), Chart Review
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days ]
Time to mobilization
Measured: Up to five postoperative days
Time to first oral nutritional intake
Measured: Up to five postoperative days
Time until leaving the recovery room
Fulfillment of discharge criteria from the recovery room
Measured: Up to leaving the recovery room
Time until leaving hospital
Fulfillment of discharge criteria from hospital after study procedure
Measured: Up to five postoperative days
Organ complications according to Clavien
Measured: Up to five postoperative days
Autonomy Preference Index (API)
Measured: Up to five postoperative days
Questionnaire for shared decision making (PEF-FB-9)
Results from PEF-FB-9 are evaluated
Measured: Up to five postoperative days
Total treatment outcome in terms of quality of life of patients
EQ-5D
Measured: Up to 1 year
Total treatment outcome in terms of functional autonomy of patients
Activities of Daily Living (ADLs) or Instrumental Activities of Daily Living (IADLs)
Measured: Up to 1 year
Intraoperative Neuromonitoring
Measured: Up to the end of surgical procedure
Cerobrospinal fluid parameter
Beta-Amyloid 1-40, beta-Amyloid 1-42, beta-Amyloid Ratio (42/40*10), phospho-TAU, Protein 14-3-3, PRPSc, TAU (Gesamt-Tau) from cerobrospinal fluid for measuring dementia
Measured: Until the end of surgery
Apolipoprotein E
Blood marker Apolipoprotein E for measuring dementia
Measured: Until the end of surgery
Multiplex Gene Expression Analysis (Whole Blood)
Measured: Until first postoperative day
Antibodies
Antibody from serum (anti-beta2-adrenergic receptor, anti-muscarinic acetylcholine receptor (M3 / M4), anti-serotonin receptor, anti-dopamine receptor)
Measured: Until first postoperative day
Pro and anti-inflammatory markers
IL-8 from whole blood and IL-6, IL-8 and TGF
Measured: Until first postoperative day
Immune cells
Immune cells from citrate blood
Measured: Until first postoperative day
Autophagy of platelets
Autophagy of platelets from citrate blood
Measured: Until first postoperative day
Intracellular pH
Intracellular pH from citrate blood
Measured: Until first postoperative day
Cholinesterases
Measured: Until the third postoperative day
Anxiety 1
Anxiety 1 is measured by Generalized Anxiety Disorder 7 (GAD-7) and Patient Health Questionnaire 9 (PHQ-9)
Measured: Up to 1 year
Anxiety 2
Anxiety 2 is measured by Amsterdam Preoperative Anxiety and Information Scale (APAIS) and Faces Anxiety Scale (FAS)
Measured: Up to 1 year
Subsequent surgery
Results from subsequent surgery are evaluated
Measured: Up to 1 year
Obstructive Sleep Apnea (OSAS)
Obstructive Sleep Apnea (OSAS) is measured by the STOP-Bang Questionnaire.
Measured: Up to 1 year
Fatigue
Fatigue is monitored by Acute Fatigue Score
Measured: Up to 1 year
Sleep behavior
Sleep behaviour is measured by Insomnia Severity Index (ISI) at baseline, 3 months, 1 year
Measured: Up to 1 year
Sleep behavior
Sleep behaviour is measured by intraclinical course (immediate perioperative: Richards Campbell Sleep Questionnaire)
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days ]
Frailty
Frailty is measured with a modified frailty score according to Fried´s frailty phenotype assessment
Measured: Participants will be measured at the beginning of the investigation.
Stress
Stress is monitored by Perceived Stress Questionnaire 20 (PSQ20) and Disstressthermometer without areas
Measured: Up to 1 year
Dose of concomitant medication
The types of medications used in the management of pain, agitation, and delirium on that day are documented.
Measured: Up to 5 postoperative days
Duration of concomitant medication
The types of medications used in the management of pain, agitation, and delirium on that day are documented.
Measured: Up to 5 postoperative days
Time of mechanical ventilation
Measured: Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day]
Intensive care unit stay
Measured: Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day]
Number of stationary recoveries
Measured: Up to 1 year
Visits to doctors and outpatient treatments
Measured: Up to 1 year
Number of additional operations
Measured: Up to 1 year
Mortality
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start12 Mar 2019
- Primary completion9 Nov 2021
- Study completion14 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715244
- Sponsor's protocol ID
- PODSPA
- Status last verified
- Sep 2022
- First submitted
- 9 Oct 2018
- Last updated
- 14 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28187050Kipping 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.
PubMed 40945957
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rate of Postoperative Delirium and Postoperative Cognitive Dysfunction After Spinal Anesthesia With Short-acting Local Anesthetics Compared to General Anesthesia After a Shared Decision Making Process
- ClinicalTrials.gov ID
- NCT03715244
- Acronym / sponsor ID
- PODSPA
- Conditions
- Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 9 Nov 2021 (actual)
- Study completion
- 14 Jul 2022 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study group 1 | – | Procedure: Spinal anesthesia with short-acting local anestheticsn=220 patients for routine data of spinal anesthesia with short-acting local anesthetics |
| Study group 2 | – | Procedure: General anesthesia (current standard)n= 220 patients for routine data of 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal anesthesia with short-acting local anestheticsSpinal anesthesia in patients with duration of surgery < 90 minutes | Procedure or surgery | Study group 1 |
| General anesthesia (current standard)General anesthesia in patients with duration of surgery < 90 minutes | Procedure or surgery | Study group 2 |
Primary outcome
Rate of postoperative delirium
Time frame: Up to five postoperative days
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).
42 secondary outcomes
Perioperative cognitive disturbances
Time frame: Up to 1 year
MONTREAL COGNITIVE ASSESSMENT (MOCA)
Time frame: Up to 1 year
Formal cognitive testing
Time frame: Up to 1 year
Postoperative cognitive dysfunction (POCD)
Time frame: Up to 1 year
Duration of delirium
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ]
Severity of delirium
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ]
Time to mobilization
Time frame: Up to five postoperative days
Time to first oral nutritional intake
Time frame: Up to five postoperative days
Time until leaving the recovery room
Time frame: Up to leaving the recovery room
Time until leaving hospital
Time frame: Up to five postoperative days
Organ complications according to Clavien
Time frame: Up to five postoperative days
Autonomy Preference Index (API)
Time frame: Up to five postoperative days
Questionnaire for shared decision making (PEF-FB-9)
Time frame: Up to five postoperative days
Total treatment outcome in terms of quality of life of patients
Time frame: Up to 1 year
Total treatment outcome in terms of functional autonomy of patients
Time frame: Up to 1 year
Intraoperative Neuromonitoring
Time frame: Up to the end of surgical procedure
Cerobrospinal fluid parameter
Time frame: Until the end of surgery
Apolipoprotein E
Time frame: Until the end of surgery
Multiplex Gene Expression Analysis (Whole Blood)
Time frame: Until first postoperative day
Antibodies
Time frame: Until first postoperative day
Pro and anti-inflammatory markers
Time frame: Until first postoperative day
Immune cells
Time frame: Until first postoperative day
Autophagy of platelets
Time frame: Until first postoperative day
Intracellular pH
Time frame: Until first postoperative day
Cholinesterases
Time frame: Until the third postoperative day
Anxiety 1
Time frame: Up to 1 year
Anxiety 2
Time frame: Up to 1 year
Subsequent surgery
Time frame: Up to 1 year
Obstructive Sleep Apnea (OSAS)
Time frame: Up to 1 year
Fatigue
Time frame: Up to 1 year
Sleep behavior
Time frame: Up to 1 year
Sleep behavior
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ]
Frailty
Time frame: Participants will be measured at the beginning of the investigation.
Stress
Time frame: Up to 1 year
Dose of concomitant medication
Time frame: Up to 5 postoperative days
Duration of concomitant medication
Time frame: Up to 5 postoperative days
Time of mechanical ventilation
Time frame: Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day]
Intensive care unit stay
Time frame: Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day]
Number of stationary recoveries
Time frame: Up to 1 year
Visits to doctors and outpatient treatments
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Background: PubMed 28187050Aldecoa 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.
- Derived from this study: PubMed 40945957Kipping 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, MD, Prof. study director
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of postoperative delirium (time frame: Up to five postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03715244, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.