Ketamine Co-induction for Patients With Major Depressive Disorder

September 12, 2018 updated by: University of Saskatchewan

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At time of discharge from post-anesthetic care unit, until 3 hours post operatvie
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.
72 hours post-operative
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.
7-days post-operative
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.
30-days post-operative

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Saskatchewan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2018

Primary Completion (ANTICIPATED)

December 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

August 15, 2018

First Submitted That Met QC Criteria

September 7, 2018

First Posted (ACTUAL)

September 11, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 13, 2018

Last Update Submitted That Met QC Criteria

September 12, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bio 18-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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