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Ketamine Co-induction for Patients With Major Depressive Disorder

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03666494
Enrollment
50
Registered
2018-09-11
Start date
2018-12-31
Completion date
2019-12-31
Last updated
2018-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Depression, Ketamine

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.

Interventions

DRUGKetamine Hydrochloride

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

DRUGPropofol

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

DRUGFentanyl

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

Sponsors

University of Saskatchewan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Depression SeverityAt time of discharge from post-anesthetic care unit, until 3 hours post operatvieSeverity 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

MeasureTime frameDescription
Pain ScorePre-operativelyVerbally reported numeric pain score (out of 10)
Analgesia usePre-operativelyMorphine equivalents (in milligrams)

Contacts

Primary ContactJonathan Gamble, MD
j_gamble@yahoo.com306-655-1183
Backup ContactJordon Steeg, MD
jordon.steeg@usask.ca306-222-9782

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026