Ketamine Co-induction for Patients With Major Depressive Disorder

Phase 4

• Conditions: Depression; Anesthesia; Ketamine
• Interventions: Drug: Propofol; Drug: Ketamine Hydrochloride; Drug: Fentanyl

• Registration Number: NCT03666494
• Lead Sponsor: University of Saskatchewan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-15
• Study First Submitted QC: 2018-09-07
• Study First Posted: 2018-09-11
• Last Update Submitted: 2018-09-12
• Last Update Posted: 2018-09-13
• Study Start: 2018-12
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Arm	Propofol	As part of the patient's anesthetic induction, they will receive propofol and fentanyl.
Control Arm	Fentanyl	As part of the patient's anesthetic induction, they will receive propofol and fentanyl.
Ketamine Arm	Ketamine Hydrochloride	As part of the patient's anesthetic induction, they will receive propofol, fentanyl, as well as ketamine hydrochloride.
Ketamine Arm	Propofol	As part of the patient's anesthetic induction, they will receive propofol, fentanyl, as well as ketamine hydrochloride.
Ketamine Arm	Fentanyl	As part of the patient's anesthetic induction, they will receive propofol, fentanyl, as well as ketamine hydrochloride.

Primary Outcome Measures

Name	Time	Method
Depression Severity	30-days post-operative	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.

Secondary Outcome Measures

Name	Time	Method
Analgesia use	30-days post-operative	Morphine equivalents (in milligrams)
Pain Score	30-days post-op	Verbally reported numeric pain score (out of 10)