Clinical trial NCT03861988: Intraoperative Ketamine Versus Saline in Depressed Patients Undergoing Anesthesia for Non-cardiac Surgery
Official title: Double-blind Trial of Intraoperative Ketamine Versus Saline in Depressed Patients Undergoing Anesthesia for Non-cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Surgery
Orthopedic Disorder
Keywords: depression
ketamine
anesthesia
total joint arthroplasty
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Pregnant of breastfeeding women

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS) Score
timeFrame: Post-intervention days 1, 2 and 3
Secondary outcomes:
measure: Number of Participants With Clinical Response
timeFrame: Post-intervention days 1, 2 and 3
measure: Number of Participants With Remission
timeFrame: Post-intervention day 14
measure: Hospital Anxiety and Depression Scale (HADS) Scale Score
timeFrame: Post-intervention days 1, 2, 3, 5, 7 and 14
measure: Cumulative Opioid Use
timeFrame: Post-intervention days 1, 2, 3, 5, 7 and 14
measure: Hospital Length of Stay
timeFrame: Average approximately 3 days post-intervention
measure: Brief Pain Inventory Pain Intensity Scale Score
timeFrame: Post-intervention days 1, 2, 3, 5, 7 and 14
measure: Brief Pain Inventory Pain Interference Scale Score
timeFrame: Post-intervention days 1, 2, 3, 5, 7 and 14
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Boris D Heifets, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979 Apr;134:382-9. doi: 10.1192/bjp.134.4.382.