Effects of Low Dose Ketamine Given at Induction of Anesthesia on Postoperative Mood in Patients With Depressive Symptoms

January 22, 2018 updated by: The University of Texas Health Science Center at San Antonio
Ketamine has been shown to have an antidepressant effect when given intravenously in doses of 2mg/kg. Ketamine is used as a standard induction drug during general anesthesia. It is known in this instance to decrease postoperative pain. No one has studied whether or not ketamine when given in doses used during general anesthesia (0.5mg/kg intravenous) has an antidepressant effect on surgical patients who suffer from depression. The study is designed to determine whether or not a small dose of ketamine when given at the induction of anesthesia could have an antidepressant effect on surgical patients with depression.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Non-pregnant females between the ages of 18-65 who are being admitted for gynecological surgery will be given a bedside Goldberg depression screen as part of their routine preanesthetic assessment. If the patient scores five or above on the Goldberg depression screening, they will be asked if they would like to enroll in the study. Exclusion criteria include uncontrolled hypertension, pregnancy, or allergy to ketamine.

Once the patient is consented they will be randomized to one of two groups. Every patient will receive an antianxiety medication Midazolam and a narcotic fentanyl prior to going to the operating room. Group A will receive ketamine 0.5mg/kg intravenous as part of their induction for general anesthesia. Group B will not receive ketamine as part of their anesthetic. All other induction drugs will be at the discretion of the anesthesiologist performing the anesthetic.

The patients will be seen by a separate anesthesia provider (who is blinded to the group the patient is in) and the results of the depression screening will be added to the patient's data sheet.

The patients will be followed again one week after their surgery either in their hospital room (if still hospitalized) or by phone. They will again be given the Goldberg Depression screen and the data will again be added to their data sheet.

Several times during the study and at its conclusion the data will be matched with the patients group in order to assess for adverse events such as suicidal ideations, nausea and vomiting. If adverse events are noted, the study design will be altered to take into account the adverse events.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • University Hospital

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:

  • History of or current depression scoring five or above on Goldberg Depression Screen

Exclusion Criteria:

  • Uncontrolled hypertension, allergy to ketamine,pregnancy

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: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Ketamine Group
This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia.
Drug: ketamine
Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia.
Other Names:
  • ketalar
NO_INTERVENTION: No ketamine group
This group will not receive ketamine at induction of general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression Score Using Goldberg Depression Screening Test
Time Frame: One week

The Goldberg screening test consists of 18 questions which are answered based upon the previous 10-14 days to assess depression:

0-not at all

  1. just a little
  2. somewhat
  3. moderately
  4. quite a lot
  5. very much

The scores are summed, and the ranges are assessed:

0 - 9 No depression likely 10 - 21 Possible symptoms that may be due to depression or other medical issues.

22 - 35 Mild to Moderate Depression. 36 - 53 Moderate to Severe Depression 54 and up Severely Depressed The higher the score, the more severe you depression is likely to be.
One week

Collaborators and Investigators

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

Sponsor

The University of Texas Health Science Center at San Antonio

Investigators

  • Principal Investigator: Bonny C Gillis, M.D., Department of Anesthesiology UTHSCSA

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

December 1, 2015

Primary Completion (ACTUAL)

September 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

April 16, 2015

First Submitted That Met QC Criteria

April 20, 2015

First Posted (ESTIMATE)

April 21, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 15, 2018

Last Update Submitted That Met QC Criteria

January 22, 2018

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC20150248H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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