Clinical TrialDepressive DisordersKetaminePlaceboCompleted

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.

Target Enrollment
32 participants
Study Type
Phase III interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomised, double-blind, placebo-controlled, parallel-group feasibility trial at Washington University School of Medicine/Barnes-Jewish Hospital assessing whether a postoperative low-dose ketamine infusion prevents depressive symptoms in neurosurgical patients with a history of depression.

Intervention: single postoperative IV bolus of ketamine 0.5 mg/kg over 10 minutes followed by infusion 0.3 mg/kg/h for 2 hours 50 minutes; comparator: equal-volume normal saline. Primary aim is feasibility for a future phase 3 prevention trial; outcomes include depressive symptom measures and safety/tolerability.

Study Protocol

Preparation

sessions

Dosing

1 sessions
180 min each

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Following surgery and extubation, patients receive ketamine 0.5 mg/kg bolus over 10 minutes then 0.3 mg/kg/h infusion for 2 hours 50 minutes.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose

    0.5 mg/kg IV bolus over 10 min then 0.3 mg/kg/h infusion for 2 h 50 min

Placebo

inactive

Following surgery and extubation, patients receive normal saline at an equal rate to the ketamine arm.

Interventions

  • Placebo
    via IV• single dose

    Normal saline, equal volume and rate to ketamine arm

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Able to provide written, informed consent
  • 2. Aged 18 or older
  • 3. Scheduled for non-ambulatory surgery scheduled to last at least 2 hours at Barnes-Jewish Hospital
  • 4. 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

  • Exclusion Criteria:
  • 1. Bipolar depression
  • 2. Concurrent use of a medication contraindicated with ketamine
  • 3. Emergent surgery
  • 4. Known or suspected elevation in intracranial pressure
  • 5. Current 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. Known history of dementia
  • 10. Pregnancy or lactation
  • 11. Inability to converse in English
  • 12. Concurrent enrollment in another interventional trial

Study Details

  • Status
    Completed
  • Phase
    Phase III
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment32 participants
  • Timeline
    Start: 2022-04-25
    End: 2023-03-08
  • Compounds
    KetaminePlacebo
  • Topic
    Depressive Disorders

Locations

Washington University School of Medicine — St Louis, Missouri, United States

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