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Intraoperative Ketamine Versus Saline in Patients With Major Depressive Disorder Undergoing Anesthesia for Total Joint Surgery

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ClinicalTrials.gov Identifier: NCT03861988
Recruitment Status : Not yet recruiting
First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Boris D. Heifets, Stanford University

Brief Summary:
This study evaluates whether ketamine, given as part of an anesthetic, improves depression symptoms in depressed patients undergoing total joint replacement surgery. Half of participants will receive a ketamine infusion during surgery, while the other half will receive a placebo (normal saline) during surgery.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Surgery Orthopedic Disorder Drug: Ketamine Drug: Normal saline (placebo) Phase 4

Detailed Description:
Major Depressive Disorder (MDD) is widely prevalent among patients preparing to have surgery, and is a known risk factor for complications after surgery, including wound infection, myocardial infarction and opioid use disorder. Ketamine has emerged as an effective, rapid-acting antidepressant therapy for patients with MDD, and may be a useful tool to prevent MDD-related morbidity in the perioperative period. Ketamine has been well studied for MDD in outpatient clinics where it is given as an infusion (0.5 mg/kg over 40 minutes) in awake patients. Ketamine is often used as part of an anesthetic cocktail in sedated or anesthetized patients, but it is unknown whether ketamine has an antidepressant effect in this context. The investigators will determine whether a ketamine infusion, compared to placebo (normal saline infusion), has an antidepressant effect when given during surgical anesthesia. If ketamine is an effective antidepressant in this population under anesthesia, its use could be incorporated into a set of interventions to minimize the perioperative complications associated with MDD.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Masking is for double blind phase only.
Primary Purpose: Treatment
Official Title: Double-blind Trial of Intraoperative Ketamine Versus Saline in Patients With Major Depressive Disorder Undergoing Anesthesia for Total Joint Surgery
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Open label ketamine
Patients will receive an intravenous ketamine infusion during surgery.
Drug: Ketamine
0.5 mg/kg over 40 minutes, intravenous.
Other Name: Ketalar.

Experimental: Double blind ketamine
Patients will receive an intravenous ketamine infusion during surgery.
Drug: Ketamine
0.5 mg/kg over 40 minutes, intravenous.
Other Name: Ketalar.

Placebo Comparator: Double blind placebo
Participants will receive placebo (normal saline infusion) during surgery.
Drug: Normal saline (placebo)
Normal saline infusion over 40 minutes, equivalent volume to ketamine infusion.




Primary Outcome Measures :
  1. Composite score on Hospital Anxiety and Depression Scale (HADS) and Montgomery-Asberg Depression Rating Scales (MADRS) [ Time Frame: 1 to 5 days post procedure (up to 20 minutes to complete survey) ]
    This outcome measures a composite of the HADS and MADRS depression rating scales. The composite score range is 0 to 81. A lower score indicate lower severity of symptoms. The assessment for this outcome measure will be taken once between days 1 and 5 post procedure.


Secondary Outcome Measures :
  1. Pain at surgical site: scale of 0-10 [ Time Frame: 1 to 5 days post procedure (up to 5 minutes to complete survey) ]
    This outcome measures average pain at the surgical site as reported by the patient on a scale of 0-10, with lower scores corresponding to less pain ("0" = no pain) and higher scores corresponding to more pain. The assessment for this outcome measure will be taken once between days 1 and 5 following the procedure.

  2. Pain at surgical site: scale of 0-10 [ Time Frame: 14 days post procedure (up to 5 minutes to complete survey) ]
    This outcome measures average pain at the surgical site as reported by the patient on a scale of 0-10, with lower scores corresponding to less pain ("0" = no pain) and higher scores corresponding to more pain.

  3. Opioid consumption [ Time Frame: 0 to 14 days post procedure ]
    This outcome measures how many cumulative morphine-equivalents milligrams of opioid pain medication the patient has taken.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient presenting for primary total joint arthroplasty
  • Major Depressive Disorder

Exclusion Criteria:

  • Pregnant of breastfeeding women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03861988


Locations
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United States, California
Stanford University Not yet recruiting
Stanford, California, United States, 94305
Contact: Boris D Heifets, MD, PhD    917-620-4241    bheifets@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Boris D Heifets, MD, PhD Stanford University

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Responsible Party: Boris D. Heifets, Assistant Professor of Anesthesiology, Stanford University
ClinicalTrials.gov Identifier: NCT03861988     History of Changes
Other Study ID Numbers: 49114
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No current plan to share data.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Boris D. Heifets, Stanford University:
depression
ketamine
anesthesia
total joint arthroplasty

Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Musculoskeletal Diseases
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Anesthetics
Ketamine
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action