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Ketamine Co-induction for Patients With Major Depressive Disorder

Sponsor
University of Saskatchewan (Other)
Overall Status
Unknown status
CT.gov ID
NCT03666494
Collaborator
(none)
50
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Ketamine Co-induction for Patients With Major Depressive Disorder; a Randomized Clinical Trial
Anticipated Study Start Date :
Dec 1, 2018
Anticipated Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control Arm

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

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

Drug: Fentanyl
As part of the patient's anesthetic induction, they will receive fentanyl.
Active Comparator: Ketamine Arm

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

Drug: Ketamine Hydrochloride
As part of anesthetic induction, the addition of ketamine hydrochloride 0.5mg/kg.

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

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

Outcome Measures

Primary Outcome Measures

  1. Depression Severity [At time of discharge from post-anesthetic care unit, until 3 hours post operatvie]

    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.

  2. Depression Severity [72 hours 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.

  3. Depression Severity [7-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.

  4. 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

  1. Pain Score [Pre-operatively]

    Verbally reported numeric pain score (out of 10)

  2. Pain Score [Upon discharge from PACU, up to 3 hours postoperative]

    Verbally reported numeric pain score (out of 10)

  3. Pain Score [72 hours post-opertaive]

    Verbally reported numeric pain score (out of 10)

  4. Pain Score [7-days post-op]

    Verbally reported numeric pain score (out of 10)

  5. Pain Score [30-days post-op]

    Verbally reported numeric pain score (out of 10)

  6. Analgesia use [Pre-operatively]

    Morphine equivalents (in milligrams)

  7. Analgesia use [Upon discharge from PACU, up to 3 hours postoperative]

    Morphine equivalents (in milligrams)

  8. Analgesia use [72 hours post-operative]

    Morphine equivalents (in milligrams)

  9. Analgesia use [7-days post-operative]

    Morphine equivalents (in milligrams)

  10. Analgesia use [30-days post-operative]

    Morphine equivalents (in milligrams)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Saskatchewan

Investigators

  • Principal Investigator: Jonathan Gamble, MD, University of Saskatchewan

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT03666494
Other Study ID Numbers:
  • Bio 18-19
First Posted:
Sep 11, 2018
Last Update Posted:
Sep 13, 2018
Last Verified:
Aug 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Fentanyl
Ketamine
Propofol

Study Results

No Results Posted as of Sep 13, 2018