Ketamine for Postoperative Avoidance of Depressive Symptoms: The K-PASS Feasibility Trial (K-PASS)

This double-blinded, placebo-controlled feasibility trial (n=32) investigates the potential of a postoperative low-dose ketamine infusion to prevent depressive symptoms in neurosurgical patients with a history of depression.

The trial, conducted by Washington University School of Medicine, assesses the feasibility of conducting a larger phase III trial. Patients, once extubated, are randomly assigned to either the ketamine group or the control group. The ketamine group receives a bolus of ketamine followed by an infusion, while the control group receives normal saline. The study aims to determine the fraction of approached patients who enrol and are randomized, the fraction of randomized patients who complete the study infusion, and the fraction of randomized patients with depression rating scale scores at specified time points.

The study’s primary purpose is prevention, following a randomized, placebo-controlled, double-blinded, parallel design. The trial occurs at Washington University in St. Louis School of Medicine/Barnes-Jewish Hospital. Inclusion criteria include adults aged 18 or older scheduled for non-ambulatory surgery lasting at least two hours at Barnes-Jewish Hospital with a past medical history of depression. Exclusion criteria include bipolar depression, certain surgical procedures, allergy to ketamine, among others.

The study commenced on April 25, 2022, and was completed on March 8, 2023. It involves a phase III intervention, with primary outcomes including assessing the feasibility of the ketamine infusion and its effect on preventing postoperative depressive symptoms. The study’s results were first posted on April 10, 2024.

Trial Details

This protocol describes a feasibility trial that will evaluate the feasibility of conducting a full-scale phase 3 trial testing the hypothesis 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.

Trial Number NCT05233566

Data attribution

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