CompletedPhase 3ketamine

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

NCT ID

NCT01690988

Target Enrollment

746 participants

Start Date

2014-02-01

Est. Completion

2017-07

About This Study

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).

Conditions Studied

Delirium

Interventions

•Ketamine (0.5 mg/kg)
•Normal Saline (placebo)
•Ketamine (1 mg/kg)

Eligibility

Age:60 Years - N/A

Healthy Volunteers:No

View full eligibility 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)

Study Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States