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NCT Number: NCT03861988

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

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.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders Musculoskeletal Diseases Orthopedic Disorder Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient presenting for non-cardiac, non-intracranial surgery
  • Major Depressive Disorder

Exclusion criteria

  • Pregnant of breastfeeding women

Treatment and study plan

ketamine

Drug

0.5 mg/kg over 40 minutes, intravenous.

Other names: Ketalar.

Normal saline (placebo)

Drug

Normal saline infusion over 40 minutes, equivalent volume to ketamine infusion.

Primary outcomes

  1. Montgomery-Asberg Depression Rating Scale (MADRS) Score

    Time frame: Post-intervention days 1, 2 and 3

    The MADRS is a 10-item scale for the evaluation of depressive symptoms (Montgomery et al 1979). Each MADRS item is rated on a 0 to 6 scale. Total score range from 0-60, where lower MADRS scores indicate lower levels of depressive symptoms. The assessment for this outcome will be taken once daily on days 1, 2 and 3 post procedure. A mixed model for repeated measures (MMRM) was used to analyze the difference in postoperative MADRS score between ketamine and placebo groups..

Secondary outcomes

  1. Number of Participants With Clinical Response

    Time frame: Post-intervention days 1, 2 and 3

    Clinical response defined as >=50% reduction in MADRS score from baseline. MADRS score range: 0 to 60, a lower score indicates lower severity of symptoms.

  2. Number of Participants With Remission

    Time frame: Post-intervention day 14

    Remission defined as a MADRS score of <=12 on day 14. MADRS score range: 0 to 60, a lower score indicates lower severity of symptoms.

  3. Hospital Anxiety and Depression Scale (HADS) Scale Score

    Time frame: Post-intervention days 1, 2, 3, 5, 7 and 14

    This outcome measures self-reported symptoms of anxiety and depression on a scale that ranges from 0 to 42. A lower score indicates lower severity of symptoms.

  4. Cumulative Opioid Use

    Time frame: Post-intervention days 1, 2, 3, 5, 7 and 14

    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: Average approximately 3 days post-intervention

    Number of days from admission (day of surgery) through discharge after surgery.

  6. Brief Pain Inventory Pain Intensity Scale Score

    Time frame: Post-intervention days 1, 2, 3, 5, 7 and 14

    Average pain intensity in the past 24 hours, rated on a numerical scale from 0 to 10 (with 0 representing "No pain" and 10 representing "Pain as bad as you can imagine").

  7. Brief Pain Inventory Pain Interference Scale Score

    Time frame: Post-intervention days 1, 2, 3, 5, 7 and 14

    Pain interference in the past 24 hours, rated on a numerical scale from 0 to 10 (with 0 representing "Does not interfere" and 10 representing "Completely interferes").

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Double-blind Trial of Intraoperative Ketamine Versus Saline in Depressed Patients Undergoing Anesthesia for Non-cardiac Surgery

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 5, 2019
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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