Ketamine Co-induction for Patients With Major Depressive Disorder

Study Overview
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Brief Summary
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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.

Official Title
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Ketamine Co-induction for Patients With Major Depressive Disorder; a Randomized Clinical Trial

Conditions
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Ketamine, Depression, Anesthesia

Intervention / Treatment
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* Drug: Ketamine Hydrochloride
* Drug: Propofol
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Arm<br>As part of the patient's anesthetic induction, they will receive propofol and fentanyl. | Drug: Propofol<br>* As part of the patient's anesthetic induction, they will receive propofol.<br>Drug: Fentanyl<br>* As part of the patient's anesthetic induction, they will receive fentanyl.<br>|
| Active Comparator: Ketamine Arm<br>As part of the patient's anesthetic induction, they will receive propofol, fentanyl, as well as ketamine hydrochloride. | Drug: Ketamine Hydrochloride<br>* As part of anesthetic induction, the addition of ketamine hydrochloride 0.5mg/kg.<br>Drug: Propofol<br>* As part of the patient's anesthetic induction, they will receive propofol.<br>Drug: Fentanyl<br>* As part of the patient's anesthetic induction, they will receive fentanyl.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 30-days post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score | Verbally reported numeric pain score (out of 10) | Pre-operatively | 
| Pain Score | Verbally reported numeric pain score (out of 10) | Upon discharge from PACU, up to 3 hours postoperative | 
| Pain Score | Verbally reported numeric pain score (out of 10) | 72 hours post-opertaive | 
| Pain Score | Verbally reported numeric pain score (out of 10) | 7-days post-op | 
| Pain Score | Verbally reported numeric pain score (out of 10) | 30-days post-op | 
| Analgesia use | Morphine equivalents (in milligrams) | Pre-operatively | 
| Analgesia use | Morphine equivalents (in milligrams) | Upon discharge from PACU, up to 3 hours postoperative | 
| Analgesia use | Morphine equivalents (in milligrams) | 72 hours post-operative | 
| Analgesia use | Morphine equivalents (in milligrams) | 7-days post-operative | 
| Analgesia use | Morphine equivalents (in milligrams) | 30-days post-operative |