Rate of Postoperative Delirium and Postoperative Cognitive Dysfunction After Spinal Anesthesia

Delirium Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03715244
• Other study ID #: PODSPA
• Status: Completed
• Start date: March 12, 2019
• Est. completion date: July 14, 2022

Study information

• Verified date: September 2022
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: July 14, 2022
• Est. primary completion date: November 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Delirium
• Postoperative Cognitive Complications

Intervention

Procedure:
• Spinal anesthesia with short-acting local anesthetics
Spinal anesthesia in patients with duration of surgery < 90 minutes
• General anesthesia (current standard)
General anesthesia in patients with duration of surgery < 90 minutes

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. Review. Erratum in: Eur J Anaesthesiol. 2018 Sep;35(9):718-719. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Perioperative cognitive disturbances	Cognitive disorders are evaluated according to DSM-V (formal cognitive testing, subjective memory sensing and instrumental activities of daily living, ).	Up to 1 year
Secondary	MONTREAL COGNITIVE ASSESSMENT (MOCA)	Test performance of the MONTREAL COGNITIVE ASSESSMENT (MOCA) for screening of dementia	Up to 1 year
Secondary	Formal cognitive testing	Perioperative changes of damain specific test performance in formal cognitive testing	Up to 1 year
Secondary	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.	Up to 1 year
Secondary	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	Participants will be followed for the duration of hospital stay, an expected average of 7 days ]
Secondary	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	Participants will be followed for the duration of hospital stay, an expected average of 7 days ]
Secondary	Time to mobilization		Up to five postoperative days
Secondary	Time to first oral nutritional intake		Up to five postoperative days
Secondary	Time until leaving the recovery room	Fulfillment of discharge criteria from the recovery room	Up to leaving the recovery room
Secondary	Time until leaving hospital	Fulfillment of discharge criteria from hospital after study procedure	Up to five postoperative days
Secondary	Organ complications according to Clavien		Up to five postoperative days
Secondary	Autonomy Preference Index (API)		Up to five postoperative days
Secondary	Questionnaire for shared decision making (PEF-FB-9)	Results from PEF-FB-9 are evaluated	Up to five postoperative days
Secondary	Total treatment outcome in terms of quality of life of patients	EQ-5D	Up to 1 year
Secondary	Total treatment outcome in terms of functional autonomy of patients	Activities of Daily Living (ADLs) or Instrumental Activities of Daily Living (IADLs)	Up to 1 year
Secondary	Intraoperative Neuromonitoring		Up to the end of surgical procedure
Secondary	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	Until the end of surgery
Secondary	Apolipoprotein E	Blood marker Apolipoprotein E for measuring dementia	Until the end of surgery
Secondary	Multiplex Gene Expression Analysis (Whole Blood)		Until first postoperative day
Secondary	Antibodies	Antibody from serum (anti-beta2-adrenergic receptor, anti-muscarinic acetylcholine receptor (M3 / M4), anti-serotonin receptor, anti-dopamine receptor)	Until first postoperative day
Secondary	Pro and anti-inflammatory markers	IL-8 from whole blood and IL-6, IL-8 and TGF	Until first postoperative day
Secondary	Immune cells	Immune cells from citrate blood	Until first postoperative day
Secondary	Autophagy of platelets	Autophagy of platelets from citrate blood	Until first postoperative day
Secondary	Intracellular pH	Intracellular pH from citrate blood	Until first postoperative day
Secondary	Cholinesterases		Until the third postoperative day
Secondary	Anxiety 1	Anxiety 1 is measured by Generalized Anxiety Disorder 7 (GAD-7) and Patient Health Questionnaire 9 (PHQ-9)	Up to 1 year
Secondary	Anxiety 2	Anxiety 2 is measured by Amsterdam Preoperative Anxiety and Information Scale (APAIS) and Faces Anxiety Scale (FAS)	Up to 1 year
Secondary	Subsequent surgery	Results from subsequent surgery are evaluated	Up to 1 year
Secondary	Obstructive Sleep Apnea (OSAS)	Obstructive Sleep Apnea (OSAS) is measured by the STOP-Bang Questionnaire.	Up to 1 year
Secondary	Fatigue	Fatigue is monitored by Acute Fatigue Score	Up to 1 year
Secondary	Sleep behavior	Sleep behaviour is measured by Insomnia Severity Index (ISI) at baseline, 3 months, 1 year	Up to 1 year
Secondary	Sleep behavior	Sleep behaviour is measured by intraclinical course (immediate perioperative: Richards Campbell Sleep Questionnaire)	Participants will be followed for the duration of hospital stay, an expected average of 7 days ]
Secondary	Frailty	Frailty is measured with a modified frailty score according to Fried´s frailty phenotype assessment	Participants will be measured at the beginning of the investigation.
Secondary	Stress	Stress is monitored by Perceived Stress Questionnaire 20 (PSQ20) and Disstressthermometer without areas	Up to 1 year
Secondary	Dose of concomitant medication	The types of medications used in the management of pain, agitation, and delirium on that day are documented.	Up to 5 postoperative days
Secondary	Duration of concomitant medication	The types of medications used in the management of pain, agitation, and delirium on that day are documented.	Up to 5 postoperative days
Secondary	Time of mechanical ventilation		Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day]
Secondary	Intensive care unit stay		Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day]
Secondary	Number of stationary recoveries		Up to 1 year
Secondary	Visits to doctors and outpatient treatments		Up to 1 year
Secondary	Number of additional operations		Up to 1 year
Secondary	Mortality		Up to 1 year