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

Primary Purpose

Postoperative Delirium

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Haloperidol
Ketamine
Haloperidol + Ketamine
Saline solution (NaCl 0.9%)
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Delirium focused on measuring Postoperative delirium, Cortisol, NSE, S-100beta, MMSE, Nu-DESC, ICDSC, DOS, Haloperidol, Ketamine, Combination of Haloperidol and Ketamine, Placebo, Prevention of

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital Basel

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Haloperidol

Ketamine

Haloperidol + Ketamine

Saline solution (NaCl 0.9%)

Arm Description

Haloperidol 0.005mg/kg at induction of anesthesia

Ketamine 1mg/kg at induction of anesthesia

Combination of Haloperidol + Ketamine in same dosage at induction of anesthesia

Placebo

Outcomes

Primary Outcome Measures

Differences among study groups - Significant drop in MMSE of two points in one of the three postoperative follow-up days
Significant drop in MMSE of two points in one of the three postoperative follow-up days (ICU patients excluded)

Secondary Outcome Measures

Quantification of incidence of postoperative delirium based on cognitive testing and lab parameters
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?)

Full Information

First Posted
April 7, 2015
Last Updated
January 21, 2019
Sponsor
University Hospital, Basel, Switzerland
Collaborators
Kantonsspital Baden
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1. Study Identification

Unique Protocol Identification Number
NCT02433041
Brief Title
Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial
Acronym
PRIDe
Official Title
Baden PRIDe Trial - Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 21, 2018 (Actual)
Study Completion Date
December 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
Kantonsspital Baden

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Delirium
Keywords
Postoperative delirium, Cortisol, NSE, S-100beta, MMSE, Nu-DESC, ICDSC, DOS, Haloperidol, Ketamine, Combination of Haloperidol and Ketamine, Placebo, Prevention of

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Haloperidol
Arm Type
Active Comparator
Arm Description
Haloperidol 0.005mg/kg at induction of anesthesia
Arm Title
Ketamine
Arm Type
Active Comparator
Arm Description
Ketamine 1mg/kg at induction of anesthesia
Arm Title
Haloperidol + Ketamine
Arm Type
Active Comparator
Arm Description
Combination of Haloperidol + Ketamine in same dosage at induction of anesthesia
Arm Title
Saline solution (NaCl 0.9%)
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Haloperidol
Intervention Description
Haloperidol 0.005mg/kg at induction of anesthesia
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
Ketamine 1mg/kg at induction of anesthesia to test its power to prevent postoperative delirium
Intervention Type
Drug
Intervention Name(s)
Haloperidol + Ketamine
Intervention Description
Haloperidol 0.005mg/kg + Ketamine 1mg/kg at induction of anesthesia to test their power to prevent postoperative delirium if given together
Intervention Type
Drug
Intervention Name(s)
Saline solution (NaCl 0.9%)
Intervention Description
Placebo being used in one of the four groups
Primary Outcome Measure Information:
Title
Differences among study groups - Significant drop in MMSE of two points in one of the three postoperative follow-up days
Description
Significant drop in MMSE of two points in one of the three postoperative follow-up days (ICU patients excluded)
Time Frame
5 day follow-up (preoperative, day of surgery, postoperative days 1-3)
Secondary Outcome Measure Information:
Title
Quantification of incidence of postoperative delirium based on cognitive testing and lab parameters
Description
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?)
Time Frame
5 day follow-up (preoperative, day of surgery, postoperative days 1-3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexa Hollinger, MD
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
33120302
Citation
Hollinger A, Rust CA, Riegger H, Gysi B, Tran F, Brugger J, Huber J, Toft K, Surbeck M, Schmid HR, Rentsch K, Steiner L, Siegemund M. Ketamine vs. haloperidol for prevention of cognitive dysfunction and postoperative delirium: A phase IV multicentre randomised placebo-controlled double-blind clinical trial. J Clin Anesth. 2021 Feb;68:110099. doi: 10.1016/j.jclinane.2020.110099. Epub 2020 Oct 22.
Results Reference
derived
PubMed Identifier
29482596
Citation
Riegger H, Hollinger A, Seifert B, Toft K, Blum A, Zehnder T, Siegemund M. Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial (PRIDe): a phase IV multicenter, randomized, placebo-controlled, double-blind clinical trial of ketamine versus haloperidol for prevention of postoperative delirium. Trials. 2018 Feb 26;19(1):142. doi: 10.1186/s13063-018-2498-6.
Results Reference
derived

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Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial

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