Delirium Clinical Trial
Official title:
Rivastigmine for the Prevention of Postoperative Delirium After Cardiac Surgery
The purpose of this study is to determine whether Rivastigmine is effective for the prevention of postoperative delirium in patients undergoing cardiac surgery.
Postoperative delirium is a frequent complication after cardiac surgery. In the literature
an incidence ranging from 0 - 72 % is reported. The aetiology of this complication is
multifactorial. A decline in cerebral cholinergic transmission as well as perioperative
cerebral hypoperfusion or a systemic inflammatory response triggered by the extracorporeal
circulation have been suspected. Advanced age is the most important patient-related risk
factor. A perioperative delirium is an extremely unpleasant experience for the affected
patients. Equally important is the fact that a delirium is associated with a prolonged
length of stay on the intensive care unit and in hospital. Furthermore, patients who develop
delirium have an increased six-month mortality. Recently successful treatment and prevention
of the delirium with cholinesterase inhibitors such as rivastigmine have been reported.
The proposed study will test the hypothesis that prophylactically administered rivastigmine
is able to prevent or at least reduce the symptoms of the postoperative delirium in elderly
patients undergoing elective cardiac surgery with extracorporeal circulation.
This study is designed as a double blind randomised placebo controlled trial. Half the
patients will receive placebo. The other half will receive rivastigmine 1.5m-1.5mg-1.5mg
(oral solution), starting on the evening preceding the operation and for the first seven
days postoperatively. Patients in both groups who develop delirium will be treated with a
rescue medication consisting of lorazepam and haloperidol.
Measurements will include the incidence of delirium assessed using the Confusion Assessment
Method (CAM). The severity of symptoms will by characterised by the Mini Mental Score and
clock drawing. Further measurements will include the prescribed doses of rescue medication,
the length of stay on intensive care and in hospital, the time of extracorporeal
circulation, and laboratory parameters such as CRP, albumin, lymphocyte count, vitamin B12
and folic acid levels. Side effects of rivastigmine will be quantified.
The primary endpoint of this study is the incidence of delirium. Secondary endpoints will be
the severity of delirium, the used doses of rescue medication, and length of stay (intensive
care and hospital).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04551508 -
Delirium Screening 3 Methods Study
|
||
Recruiting |
NCT05891873 -
Delirium in the (Neuro)Intensive/Critical Care in the Adult and Paediatric Czech Populations
|
||
Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
Recruiting |
NCT04792983 -
Cognition and the Immunology of Postoperative Outcomes
|
||
Recruiting |
NCT06194474 -
Study on Biomarkers of Postoperative Delirium in Elderly Cardiac Surgery Patients
|
||
Completed |
NCT03095417 -
Improving the Recovery and Outcome Every Day After the ICU
|
N/A | |
Completed |
NCT05395559 -
Prevalence and Recognition of Cognitive Impairment in Hospitalized Patients: a Flash Mob Study
|
||
Terminated |
NCT03337282 -
Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients
|
||
Not yet recruiting |
NCT04846023 -
Pediatric Delirium Screening in the PICU Via EEG
|
N/A | |
Not yet recruiting |
NCT04538469 -
Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
|
||
Not yet recruiting |
NCT03807388 -
ReMindCare App for Patients From First Episode of Psychosis Unit.
|
N/A | |
Withdrawn |
NCT02673450 -
PER3 Clock Gene Polymorphism, Clock Gene Expression and Delirium in the Intensive Care Unit.
|
||
Recruiting |
NCT03256500 -
Transcranial Direct Current Stimulation for the Treatment of Delirium
|
N/A | |
Completed |
NCT02890927 -
Geriatric-CO-mAnagement for Cardiology Patients in the Hospital
|
N/A | |
Not yet recruiting |
NCT02892968 -
ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients
|
N/A | |
Recruiting |
NCT03165539 -
Cerebral Oxygen Desaturation and Post-Operative Delirium in Thoracic Surgical Patients
|
||
Completed |
NCT02518646 -
DElirium prediCtIon in the intenSIve Care Unit: Head to Head comparisON of Two Delirium Prediction Models
|
N/A | |
Completed |
NCT02554253 -
The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction
|
Phase 2 | |
Recruiting |
NCT02305589 -
The Clinical Changes Before and After Sugammadex in the Patients Undergoing Hip Surgery on the Aspect of Delirium
|
N/A | |
Completed |
NCT02628925 -
Nu-DESC DK: The Danish Version of the Nursing Delirium Screening Scale
|
N/A |