The Prevention of Delirium and Complications Associated With Surgical Treatments Multi Center Clinical Trial

• Status: Completed
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborators: Asan Medical Center; Harvard Medical School; Harvard Medical School (HMS and HSDM); Medical College of Wisconsin; Memorial Sloan Kettering Cancer Center; Postgraduate Institute of Medical Education and Research; University Health Network, Toronto; University of Bern; University of Manitoba; University of Michigan; Virginia Mason Hospital/Medical Center; Weill Medical College of Cornell University
• Treatments: Anesthetics; Hypnotics and Sedatives; Ketamine; Polystyrene sulfonic acid

Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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)