Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial
Information source: University Hospital, Basel, Switzerland
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Delirium
Intervention: Haloperidol (Drug); Ketamine (Drug); Haloperidol + Ketamine (Drug); Saline solution (NaCl 0.9%) (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University Hospital, Basel, Switzerland Official(s) and/or principal investigator(s): Alexa Hollinger, MD, Study Director, Affiliation: University Hospital, Basel, Switzerland
Overall contact: Martin Siegemund, MD, Phone: +41613286414, Email: martin.siegemund@usb.ch
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.
Clinical Details
Official title: Baden PRIDe Trial - Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Differences among study groups - Significant drop in MMSE of two points in one of the three postoperative follow-up days
Secondary outcome: Quantification of incidence of postoperative delirium based on cognitive testing and lab parameters
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.
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age 65 years and older
- Signed agreement
Exclusion Criteria:
- 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
Locations and Contacts
Martin Siegemund, MD, Phone: +41613286414, Email: martin.siegemund@usb.ch
University Hospital Basel, Basel 4031, Switzerland; Recruiting Martin Siegemund, MD, Phone: +41613286414, Email: martin.siegemund@usb.ch Alexa Hollinger, MD, Phone: +41613286508, Email: alexa.hollinger@usb.ch Harriet Riegger, Sub-Investigator Katharina Toft, Sub-Investigator Leonie Faller, Sub-Investigator Philipp Ruland, MD, Sub-Investigator
Additional Information
Starting date: July 2013
Last updated: April 28, 2015
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