Ketamine for Postoperative Avoidance of Depressive Symptoms (K-PASS) Feasibility Study: A Randomized Clinical Trial
Abstract
This is a feasibility trial that will evaluate the feasibility of conducting a full-scale phase 3 trial. Both the feasibility trial and the full-scale trial will follow a randomized, placebo-controlled, double-blinded, parallel design. The trial will follow a superiority design. This trial will take place at a single site (Washington University in St. Louis School of Medicine/Barnes-Jewish Hospital). The primary hypothesis underlying this work is that a postoperative sustained, low-dose ketamine infusion can prevent postoperative depressive symptoms when administered to a targeted population of neurosurgical patients with a history of depression. On the day following extubation, patients will be randomized to the intervention (ketamine group) or to control (control group). Patients in the ketamine group will receive a bolus of ketamine 0.5 mg/kg intravenously over 10 minutes, followed by an infusion at 0.3 mg/kg/h for an additional 7 hours 50 minutes. Patients in the control group will receive an equal volume of normal saline. Additional details about dosing and administration are found in section 6.1.2. Patients, research staff performing assessments, and research staff performing data analysis will be blinded to treatment allocation.
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