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

Stanford University

Status and phase: Completed; Phase 4

Conditions: Orthopedic Disorder; Major Depressive Disorder; Surgery

Treatments: Drug: Ketamine; Drug: Normal saline (placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT03861988

49114

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Pregnant of breastfeeding women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 3 patient groups, including a placebo group

Open label ketamine

Experimental group

Description:

Patients will receive an intravenous ketamine infusion during surgery.

Treatment:

Drug: Ketamine

Double blind ketamine

Experimental group

Description:

Patients will receive an intravenous ketamine infusion during surgery.

Treatment:

Drug: Ketamine

Double blind placebo

Placebo Comparator group

Description:

Participants will receive placebo (normal saline infusion) during surgery.

Treatment:

Drug: Normal saline (placebo)