Ketamine Co-induction for Patients With Major Depressive Disorder

University of Saskatchewan

Status and phase: Unknown; Phase 4

Conditions: Ketamine; Depression; Anesthesia

Treatments: Drug: Propofol; Drug: Ketamine Hydrochloride; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT03666494

Bio 18-19

Details and patient eligibility

About

Ketamine hydrochloride, an anesthetic medication, has been demonstrated to acutely and rapidly improve depressive symptoms but not yet been adequately studied for this effect when used as part of a general anesthetic for surgery. This proposed single-centre, double-blinded, randomized clinical trial of adult patients with depression presenting for gynecologic surgery would compare severity of depressive symptoms between patients receiving and not receiving ketamine as part of their general anesthetic.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of major depressive disorder
• Presentation for gynecologic surgery requiring a general anesthetic

Exclusion criteria

• Marked co-morbid cardiovascular disease
• Marked co-morbid respiratory disease
• History of intracranial hypertension
• History of seizures
• ASA Physical Status Classification IV or greater
• History of psychosis
• Current pregnancy
• Contraindication to ketamine administration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Control Arm

Active Comparator group

Description:

As part of the patient's anesthetic induction, they will receive propofol and fentanyl.

Treatment:

Drug: Propofol

Drug: Fentanyl

Ketamine Arm

Active Comparator group

Description:

As part of the patient's anesthetic induction, they will receive propofol, fentanyl, as well as ketamine hydrochloride.

Treatment:

Drug: Propofol

Drug: Ketamine Hydrochloride

Drug: Fentanyl