Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial
- Conditions
- Postoperative Delirium
- Interventions
- Registration Number
- NCT02433041
- Lead Sponsor
- University Hospital, Basel, Switzerland
- Brief Summary
The purpose of this study is to find out whether postoperative delirium can be more properly prevented by the combination of determined preventive agents in past studies. Further on the investigators measure pre- and postoperative cortisol, neuron specific enolase (NSE) and S-100beta levels.
- Detailed Description
The postoperative delirium remains a challenge for medical stuff concerning detection, therapy and avoidance of consequences. Over the years numerous risk factors were detected which emphasizes the importance of its prevention. Within these studies some possibilities, but no strictly defined rules of action for pharmacological or neuropsychological prevention are described. This is why in this randomized, double-blinded, placebo-controlled study, the investigators want to compare two agents that were found to prevent postoperative delirium to a certain level, even in combination: the investigators arrange the patients within four study groups, one receiving Haloperidol, one Ketamine, one both and one placebo. The patients receive the study drug only once right before induction of anesthesia. After the day of recruitment there is the day of operation and a follow-up of three days (5 days of observation in total, where the investigators will test cognitive function with Mini Mental Status Examination (MMSE), Delirium Observation Scale (DOS), Nursing Delirium Screening Scale (Nu-DESC) or Intensive Care Delirium Screening Checklist (ICDSC). Additionally the investigators will measure and compare pre- and postoperative Cortisol, NSE and S-100beta levels.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Age 65 years and older
- Signed agreement
- Delirium at admittance or MMSE score <24 points
- High risk for postoperative ICU treatment
- Haloperidol or Ketamine intolerance
- Risk of lack of cooperation
- Drug an alcohol abuse
- Dementia
- QT interval (QTc) prolongation (at least 460ms in men, at least 470ms women) or drugs influencing QT interval, such as class Ia and III antiarrhythmics, Gatifloxacin, Moxifloxacin, Pentamidin, Cotrimoxazol, Tacrolimus, Dolasetron
- Parkinson's disease
- Intake of dopaminergic drugs (Levodopa, dopamine agonists)
- Parkinsonism
- Epilepsy
- Unable to be interviewed (severe Dementia, speaking disorders, intubation, respiratory isolation, aphasia, coma, terminal illness)
- Delay of operation of more than 72 hours past hospital admittance
- Body weight >100kg
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Haloperidol + Ketamine Haloperidol + Ketamine Combination of Haloperidol + Ketamine in same dosage at induction of anesthesia Saline solution (NaCl 0.9%) Saline solution (NaCl 0.9%) Placebo Haloperidol Haloperidol Haloperidol 0.005mg/kg at induction of anesthesia Ketamine Ketamine Ketamine 1mg/kg at induction of anesthesia
- Primary Outcome Measures
Name Time Method Differences among study groups - Significant drop in MMSE of two points in one of the three postoperative follow-up days 5 day follow-up (preoperative, day of surgery, postoperative days 1-3) Significant drop in MMSE of two points in one of the three postoperative follow-up days (ICU patients excluded)
- Secondary Outcome Measures
Name Time Method Quantification of incidence of postoperative delirium based on cognitive testing and lab parameters 5 day follow-up (preoperative, day of surgery, postoperative days 1-3) Drop of one point in Nursing Delirium Screening Scale (Nu-DESC) compared pre- and postoperatively, comparison of levels of NSE, S-100beta and Cortisol (significantly elevated postoperatively?)
Trial Locations
- Locations (1)
University Hospital Basel
🇨ðŸ‡Basel, Switzerland