Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial

NCT02433041 | Completed Phase 4 DMC

• 1 other identifier: 2013DR4089
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Delirium

Keywords

Postoperative delirium; Cortisol; NSE; S-100beta; MMSE; Nu-DESC; ICDSC; DOS; Haloperidol; Ketamine; Combination of Haloperidol and Ketamine; Placebo; Prevention of

Outcome Measures

Primary Outcomes (1)

• 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)

  5 day follow-up (preoperative, day of surgery, postoperative days 1-3)

Secondary Outcomes (1)

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

  5 day follow-up (preoperative, day of surgery, postoperative days 1-3)

Study Arms (4)

Haloperidol

ACTIVE COMPARATOR

Haloperidol 0.005mg/kg at induction of anesthesia

Drug: Haloperidol

Ketamine

ACTIVE COMPARATOR

Ketamine 1mg/kg at induction of anesthesia

Drug: Ketamine

Haloperidol + Ketamine

ACTIVE COMPARATOR

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

Drug: Haloperidol + Ketamine

Saline solution (NaCl 0.9%)

PLACEBO COMPARATOR

Placebo

Drug: Saline solution (NaCl 0.9%)

Interventions

Haloperidol DRUG

Haloperidol 0.005mg/kg at induction of anesthesia

Haloperidol

Ketamine DRUG

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

Ketamine

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

Haloperidol + Ketamine

Saline solution (NaCl 0.9%) DRUG

Placebo being used in one of the four groups

Saline solution (NaCl 0.9%)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 years and older
• Signed agreement

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Kantonsspital Baden: collaborator

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 33120302 DERIVED

• 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.

  PMID: 29482596 DERIVED

MeSH Terms

Conditions

Emergence Delirium

Interventions

Haloperidol; Ketamine; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Alexa Hollinger, MD

  University Hospital, Basel, Switzerland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: May 4, 2015
• Study Start: July 1, 2013
• Primary Completion: December 21, 2018
• Study Completion: December 21, 2018
• Last Updated: January 23, 2019

Record last verified: 2019-01

Locations

CH (1)