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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-25

Study Completion Date

2023-03-08

Brief Summary

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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.

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Detailed Description

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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, 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).

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 2 hours 50 minutes. Patients in the control group will receive an equal volume of normal saline. Patients, research staff performing assessments, and research staff performing data analysis will be blinded to treatment allocation.

Conditions

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Postoperative Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ketamine Arm

Following surgery and extubation, patients will receive ketamine 0.5 mg/kg over 10 minutes followed by an infusion of 0.3 mg/kg/h for 2 hours 50 minutes.

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

NMDA antagonist

Control Arm

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

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

IV fluid acting as a placebo

Interventions

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Ketamine

NMDA antagonist

Intervention Type DRUG

Normal saline

IV fluid acting as a placebo

Intervention Type DRUG

Other Intervention Names

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Ketalar

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No