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Completed

NCT Number: NCT02433041

Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial

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.

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Key information

Conditions

Postoperative Delirium Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Basel

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  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 outcomes

  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?)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Kantonsspital Baden

Registry information

Official study title

Baden PRIDe Trial - Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial

Acronym: PRIDe

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
May 4, 2015
Registry last updated
Jan 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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