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Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial (PRIDe)

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ClinicalTrials.gov Identifier: NCT02433041
Recruitment Status : Completed
First Posted : May 4, 2015
Last Update Posted : January 23, 2019
Sponsor:
Collaborator:
Kantonsspital Baden
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Postoperative Delirium Drug: Haloperidol Drug: Ketamine Drug: Haloperidol + Ketamine Drug: Saline solution (NaCl 0.9%) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Baden PRIDe Trial - Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial
Study Start Date : July 2013
Actual Primary Completion Date : December 21, 2018
Actual Study Completion Date : December 21, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Active Comparator: Haloperidol
Haloperidol 0.005mg/kg at induction of anesthesia
Drug: Haloperidol
Haloperidol 0.005mg/kg at induction of anesthesia

Active Comparator: Ketamine
Ketamine 1mg/kg at induction of anesthesia
Drug: Ketamine
Ketamine 1mg/kg at induction of anesthesia to test its power to prevent postoperative delirium

Active Comparator: Haloperidol + Ketamine
Combination of Haloperidol + Ketamine in same dosage at induction of anesthesia
Drug: Haloperidol + Ketamine
Haloperidol 0.005mg/kg + Ketamine 1mg/kg at induction of anesthesia to test their power to prevent postoperative delirium if given together

Placebo Comparator: Saline solution (NaCl 0.9%)
Placebo
Drug: Saline solution (NaCl 0.9%)
Placebo being used in one of the four groups




Primary Outcome Measures :
  1. Differences among study groups - Significant drop in MMSE of two points in one of the three postoperative follow-up days [ Time Frame: 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 :
  1. Quantification of incidence of postoperative delirium based on cognitive testing and lab parameters [ Time Frame: 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?)



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02433041


Locations
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Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Kantonsspital Baden
Investigators
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Study Director: Alexa Hollinger, MD University Hospital, Basel, Switzerland

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02433041     History of Changes
Other Study ID Numbers: 2013DR4089
First Posted: May 4, 2015    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

Keywords provided by University Hospital, Basel, Switzerland:
Postoperative delirium
Cortisol
NSE
S-100beta
MMSE
Nu-DESC
ICDSC
DOS
Haloperidol
Ketamine
Combination of Haloperidol and Ketamine
Placebo
Prevention of

Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Anesthetics
Ketamine
Haloperidol
Haloperidol decanoate
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs