Double-blind Trial of Intraoperative Ketamine Versus Saline in Depressed Patients Undergoing Anesthesia for Non-cardiac Surgery
Overview
- Phase
- Phase 4
- Intervention
- Ketamine
- Conditions
- Major Depressive Disorder
- Sponsor
- Stanford University
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Montgomery-Asberg Depression Rating Scale (MADRS) Score
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
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.
Investigators
Boris D. Heifets
Assistant Professor of Anesthesiology
Stanford University
Eligibility Criteria
Inclusion Criteria
- •Patient presenting for non-cardiac, non-intracranial surgery
- •Major Depressive Disorder
Exclusion Criteria
- •Pregnant of breastfeeding women
Arms & Interventions
Open label ketamine
Patients will receive an intravenous ketamine infusion during surgery.
Intervention: Ketamine
Double blind ketamine
Patients will receive an intravenous ketamine infusion during surgery.
Intervention: Ketamine
Double blind placebo
Participants will receive placebo (normal saline infusion) during surgery.
Intervention: Normal saline (placebo)
Outcomes
Primary Outcomes
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
- Hospital Length of Stay(Average approximately 3 days post-intervention)
- Number of Participants With Clinical Response(Post-intervention days 1, 2 and 3)
- Number of Participants With Remission(Post-intervention day 14)
- Hospital Anxiety and Depression Scale (HADS) Scale Score(Post-intervention days 1, 2, 3, 5, 7 and 14)
- Cumulative Opioid Use(Post-intervention days 1, 2, 3, 5, 7 and 14)
- Brief Pain Inventory Pain Intensity Scale Score(Post-intervention days 1, 2, 3, 5, 7 and 14)
- Brief Pain Inventory Pain Interference Scale Score(Post-intervention days 1, 2, 3, 5, 7 and 14)