Overview

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)