Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial

Postoperative Delirium Clinical Trial

— PRIDe  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02433041
• Other study ID #: 2013DR4089
• Status: Completed
• Phase: Phase 4
• Start date: July 2013
• Est. completion date: December 21, 2018

Study information

• Verified date: January 2019
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 21, 2018
• Est. primary completion date: December 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Postoperative Delirium

Intervention

Drug:
• Haloperidol
Haloperidol 0.005mg/kg at induction of anesthesia
• Ketamine
Ketamine 1mg/kg at induction of anesthesia to test its power to prevent postoperative delirium
• Haloperidol + Ketamine
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%)
Placebo being used in one of the four groups

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Kantonsspital Baden

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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?)	5 day follow-up (preoperative, day of surgery, postoperative days 1-3)