Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial

Ketamine

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.

Intervention / Treatment

  • Haloperidol (DRUG)
    Haloperidol 0.005mg/kg at induction of anesthesia
  • Ketamine (DRUG)
    Ketamine 1mg/kg at induction of anesthesia to test its power to prevent postoperative delirium
  • Haloperidol + Ketamine (DRUG)
    Haloperidol 0.005mg/kg + Ketamine 1mg/kg at induction of anesthesia to test their power to prevent postoperative delirium if given together
  • Saline solution (NaCl 0.9%) (DRUG)
    Placebo being used in one of the four groups

Condition or Disease

  • Postoperative Delirium

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 65 Years and older   (Older Adult)
    Enrollment: 200 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jul 01, 2013
    Primary Completion: Dec 21, 2018 ACTUAL
    Completion Date: Dec 21, 2018 ACTUAL
    Study First Posted: May 04, 2015 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Jan 21, 2019

    Sponsors / Collaborators

    Lead Sponsor: University Hospital, Basel, Switzerland
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Basel, Basel-Stadt, Switzerland

    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.

    Participant Groups

    • 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

    Eligibility Criteria

    Sex: All
    Minimum Age: 65
    Age Groups: Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

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

    Secondary Outcomes

    • 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?)

    More Details

    NCT Number: NCT02433041
    Acronym: PRIDe
    Other IDs: 2013DR4089
    Study URL: https://clinicaltrials.gov/study/NCT02433041
    Last updated: Sep 29, 2023