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Intraoperative Ketamine Versus Saline in Depressed Patients Undergoing Anesthesia for Non-cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03861988
Recruitment Status : Completed
First Posted : March 5, 2019
Last Update Posted : September 28, 2022
Sponsor:
Information provided by (Responsible Party):
Boris D. Heifets, Stanford University

Study Description
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Brief Summary:
This study evaluates whether ketamine, given as part of an anesthetic, improves depression symptoms in depressed patients undergoing non-cardiac 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual 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 Depressed Patients Undergoing Anesthesia for Non-cardiac Surgery
Actual Study Start Date : August 22, 2019
Actual Primary Completion Date : September 22, 2022
Actual Study Completion Date : September 27, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. score on Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 1 to 3 days post procedure (up to 20 minutes to complete survey) ]
    This outcome measures symptoms of depression on a scales that ranges 0 to 60. A lower score indicates lower severity of symptoms. The assessment for this outcome measure will be taken once daily on days 1, 2 and 3 post procedure. A mixed model for repeated measures (MMRM) will be used to analyze the difference in postoperative MADRS score compared to pre-procedure.


Secondary Outcome Measures :
  1. Proportion of participants with clinical response (defined as >-50% reduction in MADRS score from baseline) [ Time Frame: 1 to 3 days post procedure (up to 20 minutes to complete survey) ]

Other Outcome Measures:
  1. score on Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Days 5, 7 and 14 days post procedure compared to pre-procedure ]
  2. score on Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 1 to 14 days post procedure (up to 5 minutes to complete survey) ]
    This outcome measures self-reported symptoms of anxiety and depression on a scale that ranges from 0-42. A lower score indicates lower severity of symptoms.

  3. 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.

  4. 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 as an inpatient and after discharge from hospital

  5. Hospital length of stay [ Time Frame: through study completion, an average of 2 days. ]
    Number of days from admission (day of surgery) through discharge after surgery.

  6. Pain interference score [ Time Frame: 14 days post procedure (up to 5 minutes to complete survey) ]
    This self reported outcome measure the extent to which postoperative pain interferes with typical functioning in seven domains, each rated on a scale from 0 (does not interfere) to 10 (completely interferes)

  7. Proportion of participants with remission (defined as a MADRS score of <=12 on day 14) [ Time Frame: up to 14 days post procedure (up to 20 minutes to complete survey) ]

Eligibility Criteria
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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 non-cardiac, non-intracranial surgery
  • Major Depressive Disorder

Exclusion Criteria:

  • Pregnant of breastfeeding women
Contacts and Locations
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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
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Boris D Heifets, MD, PhD Stanford University
More Information
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Responsible Party: Boris D. Heifets, Assistant Professor of Anesthesiology, Stanford University
ClinicalTrials.gov Identifier: NCT03861988    
Other Study ID Numbers: 49114
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: September 28, 2022
Last Verified: September 2022
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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Musculoskeletal Diseases
Disease
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action