Clinical trial NCT03715244: Rate of Postoperative Delirium and Postoperative Cognitive Dysfunction After Spinal Anesthesia
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

Eligibility criteria: 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

Primary outcomes:
measure: Rate of postoperative delirium
timeFrame: Up to five postoperative days
Secondary outcomes:
measure: Perioperative cognitive disturbances
timeFrame: Up to 1 year
measure: MONTREAL COGNITIVE ASSESSMENT (MOCA)
timeFrame: Up to 1 year
measure: Formal cognitive testing
timeFrame: Up to 1 year
measure: Postoperative cognitive dysfunction (POCD)
timeFrame: Up to 1 year
measure: Duration of delirium
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ]
measure: Severity of delirium
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ]
measure: Time to mobilization
timeFrame: Up to five postoperative days
measure: Time to first oral nutritional intake
timeFrame: Up to five postoperative days
measure: Time until leaving the recovery room
timeFrame: Up to leaving the recovery room
measure: Time until leaving hospital
timeFrame: Up to five postoperative days
measure: Organ complications according to Clavien
timeFrame: Up to five postoperative days
measure: Autonomy Preference Index (API)
timeFrame: Up to five postoperative days
measure: Questionnaire for shared decision making (PEF-FB-9)
timeFrame: Up to five postoperative days
measure: Total treatment outcome in terms of quality of life of patients
timeFrame: Up to 1 year
measure: Total treatment outcome in terms of functional autonomy of patients
timeFrame: Up to 1 year
measure: Intraoperative Neuromonitoring
timeFrame: Up to the end of surgical procedure
measure: Cerobrospinal fluid parameter
timeFrame: Until the end of surgery
measure: Apolipoprotein E
timeFrame: Until the end of surgery
measure: Multiplex Gene Expression Analysis (Whole Blood)
timeFrame: Until first postoperative day
measure: Antibodies
timeFrame: Until first postoperative day
measure: Pro and anti-inflammatory markers
timeFrame: Until first postoperative day
measure: Immune cells
timeFrame: Until first postoperative day
measure: Autophagy of platelets
timeFrame: Until first postoperative day
measure: Intracellular pH
timeFrame: Until first postoperative day
measure: Cholinesterases
timeFrame: Until the third postoperative day
measure: Anxiety 1
timeFrame: Up to 1 year
measure: Anxiety 2
timeFrame: Up to 1 year
measure: Subsequent surgery
timeFrame: Up to 1 year
measure: Obstructive Sleep Apnea (OSAS)
timeFrame: Up to 1 year
measure: Fatigue
timeFrame: Up to 1 year
measure: Sleep behavior
timeFrame: Up to 1 year
measure: Sleep behavior
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ]
measure: Frailty
timeFrame: Participants will be measured at the beginning of the investigation.
measure: Stress
timeFrame: Up to 1 year
measure: Dose of concomitant medication
timeFrame: Up to 5 postoperative days
measure: Duration of concomitant medication
timeFrame: Up to 5 postoperative days
measure: Time of mechanical ventilation
timeFrame: Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day]
measure: Intensive care unit stay
timeFrame: Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day]
measure: Number of stationary recoveries
timeFrame: Up to 1 year
measure: Visits to doctors and outpatient treatments
timeFrame: Up to 1 year
measure: Number of additional operations
timeFrame: Up to 1 year
measure: Mortality
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References:
citation: 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.