A Phase 4 interventional study of Haloperidol and Ketamine in Postoperative Delirium, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-23.
Sponsored by University Hospital, Basel, Switzerland · Phase 4, Interventional, and Prevention
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.
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.
1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.
This study's enrollment of 200 is above the median of 120 across 599 interventional studies indexed under Delirium.
Browse Delirium studies →University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.
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Exclusion Criteria:
Haloperidol 0.005mg/kg at induction of anesthesia
Drug: Haloperidol
Ketamine 1mg/kg at induction of anesthesia
Drug: Ketamine
Combination of Haloperidol + Ketamine in same dosage at induction of anesthesia
Drug: Haloperidol + Ketamine
Placebo
Drug: Saline solution (NaCl 0.9%)
Haloperidol 0.005mg/kg at induction of anesthesia
Ketamine 1mg/kg at induction of anesthesia to test its power to prevent postoperative delirium
Haloperidol 0.005mg/kg + Ketamine 1mg/kg at induction of anesthesia to test their power to prevent postoperative delirium if given together
Placebo being used in one of the four groups
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)
Time frame: 5 day follow-up (preoperative, day of surgery, postoperative days 1-3)
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?)
Time frame: 5 day follow-up (preoperative, day of surgery, postoperative days 1-3)
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland