Ketamine Co-induction for Patients With Major Depressive Disorder

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.

Intervention / Treatment

Ketamine Hydrochloride (DRUG)

As part of anesthetic induction, the addition of ketamine hydrochloride 0.5mg/kg.
Propofol (DRUG)

As part of the patient's anesthetic induction, they will receive propofol.
Fentanyl (DRUG)

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

Condition or Disease

Ketamine
Depression
Anesthesia

Phase

Phase 4

Study Design

Study type:	INTERVENTIONAL
Status:	Unknown status
Study results:	No Results Available
Age:	18 Years to 65 Years
Enrollment:	50 (ESTIMATED)
Funded by:	Other
Allocation:	Randomized
Primary Purpose:	Treatment
Masking TRIPLE: Participant Investigator Outcomes Assessor

Clinical Trial Dates

Start date:	Dec 01, 2018	ESTIMATED
Primary Completion:	Dec 01, 2019	ESTIMATED
Completion Date:	Dec 01, 2019	ESTIMATED
Study First Posted:	Sep 11, 2018	ACTUAL
Results First Posted:	Aug 31, 2020
Last Updated:	Sep 12, 2018

Sponsors / Collaborators

Lead Sponsor: University of Saskatchewan

Lead sponsor is responsible party

Responsible Party: N/A

Participant Groups

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

Eligibility Criteria

Sex:	Female
Minimum Age:	18
Maximum Age:	65
Age Groups:	Adult / Older Adult
Healthy Volunteers:	Yes

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

Primary Outcomes

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.
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.
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.
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 Outcomes

Verbally reported numeric pain score (out of 10)
Verbally reported numeric pain score (out of 10)
Verbally reported numeric pain score (out of 10)
Verbally reported numeric pain score (out of 10)
Verbally reported numeric pain score (out of 10)
Morphine equivalents (in milligrams)
Morphine equivalents (in milligrams)
Morphine equivalents (in milligrams)
Morphine equivalents (in milligrams)
Morphine equivalents (in milligrams)

More Details

NCT Number:	NCT03666494
Other IDs:	Bio 18-19
Study URL:	https://clinicaltrials.gov/study/NCT03666494

Last updated: Sep 29, 2023