The Prevention of Delirium and Complications Associated With Surgical Treatments Multi Center Clinical Trial
Completed · Phase 3 · Has a placebo group
Conditions studied: Delirium
In brief
Delirium is a medical term or condition that includes a temporary inability to focus attention and to think clearly. Delirium occurs commonly (10% to 70%) in patients older than 60 undergoing large surgeries. The purpose of this study is to test rigorously whether a drug called ketamine can decrease the chance that patients will experience delirium after their surgery. The investigators are also testing whether ketamine decreases postoperative pain, postoperative opioid consumption, postoperative nausea and vomiting, ICU and hospital length of stay, and adverse outcomes (e.g. hallucinations and nightmares).
Key facts
- Study ID
- NCT01690988
- Run by
- Washington University School of Medicine
- People needed
- 746
- Starts
- 2014-02-01
- Expected to finish
- 2017-07-01
- Last updated by the study team
- 2018-06-06
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients 60 and older
- Competent to provide informed consent
- Undergoing major surgery (e.g., open cardiac surgery, open or thoracoscopic thoracic surgery, abdominal surgery, open urological surgery, open gynecological surgery, major orthopedic surgery, major vascular surgery including endovascular procedures, major ear, nose and throat surgery).
You may not qualify if…
- Patients with an allergy to ketamine
- Those in whom a significant elevation of blood pressure would constitute a serious hazard (e.g., pheochromocytoma, aortic dissection)
- Unable to provide informed consent
- Patients with drug misuse history (e.g., ketamine, cocaine, heroin, amphetamine, methamphetamine, MDMA, phencyclidine, lysergic acid, mescaline, psilocybin)
- Patients taking anti-psychotic medications (e.g., chlorpromazine, clozapine, olanzapine, risperidone, haloperidol, quetiapine, risperidone, paliperidone, amisulpride, sertindole)
- Patients with a weight outside the range 50 kg - 200 kg (110 lbs - 440 lbs)
Where it is running
- Washington University School of Medicine — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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