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

University Hospital Basel

Status and phase: Completed; Phase 4

Conditions: Postoperative Delirium

Treatments: Drug: Haloperidol + Ketamine; Drug: Ketamine; Drug: Saline solution (NaCl 0.9%); Drug: Haloperidol

Study type: Interventional

Funder types: Other

Identifiers

NCT02433041

2013DR4089

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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200 participants in 4 patient groups, including a placebo group

Haloperidol

Active Comparator group

Description:

Haloperidol 0.005mg/kg at induction of anesthesia

Treatment:

Drug: Haloperidol

Ketamine

Active Comparator group

Description:

Ketamine 1mg/kg at induction of anesthesia

Treatment:

Drug: Ketamine

Haloperidol + Ketamine

Active Comparator group

Description:

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

Treatment:

Drug: Haloperidol + Ketamine

Saline solution (NaCl 0.9%)

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Saline solution (NaCl 0.9%)