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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
45
0.5 mg/kg over 40 minutes, intravenous.
Normal saline infusion over 40 minutes, equivalent volume to ketamine infusion.
Stanford University
Stanford, California, United States
Montgomery-Asberg Depression Rating Scale (MADRS) Score
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..
Time frame: Post-intervention days 1, 2 and 3
Number of Participants With Clinical Response
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.
Time frame: Post-intervention days 1, 2 and 3
Number of Participants With Remission
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.
Time frame: Post-intervention day 14
Hospital Anxiety and Depression Scale (HADS) Scale Score
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.
Time frame: Post-intervention days 1, 2, 3, 5, 7 and 14
Cumulative Opioid Use
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
Time frame: Post-intervention days 1, 2, 3, 5, 7 and 14
Hospital Length of Stay
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Number of days from admission (day of surgery) through discharge after surgery.
Time frame: Average approximately 3 days post-intervention
Brief Pain Inventory Pain Intensity Scale Score
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").
Time frame: Post-intervention days 1, 2, 3, 5, 7 and 14
Brief Pain Inventory Pain Interference Scale Score
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").
Time frame: Post-intervention days 1, 2, 3, 5, 7 and 14