NCT03666494 - Ketamine Co-induction for Patients With Major Depressive Disorder | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

50

Conditions

Ketamine Depression Anesthesia

Interventions

Ketamine HydrochlorideDRUG

As part of anesthetic induction, the addition of ketamine hydrochloride 0.5mg/kg.

PropofolDRUG

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

FentanylDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Depression Severity

Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and \>34 is severe depression.

Time frame: At time of discharge from post-anesthetic care unit, until 3 hours post operatvie

Depression Severity

Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and \>34 is severe depression.

Time frame: 72 hours post-operative

Depression Severity

Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and \>34 is severe depression.

Time frame: 7-days post-operative

Depression Severity

Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and \>34 is severe depression.

Time frame: 30-days post-operative

Secondary Outcomes

Pain Score

Verbally reported numeric pain score (out of 10)

Time frame: Pre-operatively

Pain Score

Verbally reported numeric pain score (out of 10)

Time frame: Upon discharge from PACU, up to 3 hours postoperative

Pain Score

Verbally reported numeric pain score (out of 10)

Central Contacts

Jonathan Gamble, MD

CONTACT

306-655-1183 j_gamble@yahoo.com

Jordon Steeg, MD

CONTACT

306-222-9782 jordon.steeg@usask.ca