NCT02433041

Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Postoperative Delirium

Interventions

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

Timeline

• Start date: 2013-07-01
• Primary completion: 2018-12-21
• Completion: 2018-12-21
• First posted: 2015-05-04
• Last updated: 2019-01-23

Locations

1 site across 1 country: Switzerland