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Ketamine Co-induction for Patients With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT03666494
Recruitment Status : Unknown
Verified August 2018 by University of Saskatchewan.
Recruitment status was:  Not yet recruiting
First Posted : September 11, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
University of Saskatchewan

Tracking Information
First Submitted Date  ICMJE August 15, 2018
First Posted Date  ICMJE September 11, 2018
Last Update Posted Date September 13, 2018
Estimated Study Start Date  ICMJE December 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2018)
  • Depression Severity [ Time Frame: 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.
  • Depression Severity [ Time Frame: 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.
  • Depression Severity [ Time Frame: 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.
  • Depression Severity [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2018)
  • Pain Score [ Time Frame: Pre-operatively ]
    Verbally reported numeric pain score (out of 10)
  • Pain Score [ Time Frame: Upon discharge from PACU, up to 3 hours postoperative ]
    Verbally reported numeric pain score (out of 10)
  • Pain Score [ Time Frame: 72 hours post-opertaive ]
    Verbally reported numeric pain score (out of 10)
  • Pain Score [ Time Frame: 7-days post-op ]
    Verbally reported numeric pain score (out of 10)
  • Pain Score [ Time Frame: 30-days post-op ]
    Verbally reported numeric pain score (out of 10)
  • Analgesia use [ Time Frame: Pre-operatively ]
    Morphine equivalents (in milligrams)
  • Analgesia use [ Time Frame: Upon discharge from PACU, up to 3 hours postoperative ]
    Morphine equivalents (in milligrams)
  • Analgesia use [ Time Frame: 72 hours post-operative ]
    Morphine equivalents (in milligrams)
  • Analgesia use [ Time Frame: 7-days post-operative ]
    Morphine equivalents (in milligrams)
  • Analgesia use [ Time Frame: 30-days post-operative ]
    Morphine equivalents (in milligrams)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Co-induction for Patients With Major Depressive Disorder
Official Title  ICMJE Ketamine Co-induction for Patients With Major Depressive Disorder; a Randomized Clinical Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Ketamine
  • Depression
  • Anesthesia
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Control Arm
    As part of the patient's anesthetic induction, they will receive propofol and fentanyl.
    Interventions:
    • Drug: Propofol
    • Drug: Fentanyl
  • Active Comparator: Ketamine Arm
    As part of the patient's anesthetic induction, they will receive propofol, fentanyl, as well as ketamine hydrochloride.
    Interventions:
    • Drug: Ketamine Hydrochloride
    • Drug: Propofol
    • Drug: Fentanyl
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 7, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03666494
Other Study ID Numbers  ICMJE Bio 18-19
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Saskatchewan
Study Sponsor  ICMJE University of Saskatchewan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jonathan Gamble, MD University of Saskatchewan
PRS Account University of Saskatchewan
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP