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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


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.


Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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