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

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Ketamine

Criteria

Inclusion Criteria:

1. Able to provide written, informed consent

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. Male or female, aged 18 or older

4. Scheduled for a surgery with planned intensive care unit admission at Barnes-Jewish Hospital

5. Past medical history of depression, defined as one or more of the following criteria

1. Previous diagnosis by a psychiatrist or primary care physician in an outpatient or inpatient setting, by patient report or chart documentation

2. Prescription of an oral antidepressant by a psychiatrist or primary care physician for a mood disorder

Exclusion Criteria:

1. Bipolar depression

2. Outpatient antipsychotic medication use

3. Emergent surgery

4. Known or suspected elevation in intracranial pressure

5. Subarachnoid hemorrhage

6. Carotid endarterectomy or arteriovenous malformation repair

7. Allergy to ketamine

8. Any condition in which a significant elevation of blood pressure would constitute a serious hazard (e.g., aortic dissection, pheochromocytoma)

9. Outpatient use of an anticonvulsant with significant sodium channel activity:

carbamazepine, lacosamide, lamotrigine, oxcarbazepine, phenytoin, riluzole, and valproic acid

10. Known history of dementia

11. Pregnancy or lactation

12. Inability to converse in English

13. Concurrent enrollment in another interventional trial

14. Postoperative mechanical ventilation continuing past 07:00am on postoperative day 3