Status:
COMPLETED
Ketamine for Postoperative Avoidance of Depressive Symptoms: The K-PASS Feasibility Trial
Lead Sponsor:
Washington University School of Medicine
Conditions:
Postoperative Depression
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 infusio...
Detailed Description
This protocol describes 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, p...
Eligibility Criteria
Inclusion
- Able to provide written, informed consent
- Aged 18 or older
- Scheduled for non-ambulatory surgery scheduled to last at least 2 hours at Barnes-Jewish Hospital
- Past medical history of depression, defined as one or more of the following criteria
- Previous diagnosis by a psychiatrist or primary care physician in an outpatient or inpatient setting, by patient report or chart documentation
- Prescription of an oral antidepressant by a psychiatrist or primary care physician for a mood disorder
Exclusion
- Bipolar depression
- Concurrent use of a medication contraindicated with ketamine
- Emergent surgery
- Known or suspected elevation in intracranial pressure
- Current subarachnoid hemorrhage
- Carotid endarterectomy or arteriovenous malformation repair
- Allergy to ketamine
- Any condition in which a significant elevation of blood pressure would constitute a serious hazard (e.g., aortic dissection, pheochromocytoma)
- Known history of dementia
- Pregnancy or lactation
- Inability to converse in English
- Concurrent enrollment in another interventional trial
Key Trial Info
Start Date :
April 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05233566
Start Date
April 25 2022
End Date
March 8 2023
Last Update
April 10 2024
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110