Effects of Low Dose Ketamine Given at Induction of Anesthesia on Postoperative Mood in Patients With Depressive Symptoms
Information source: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression; Major Depressive Disorder
Intervention: ketamine (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: The University of Texas Health Science Center at San Antonio Official(s) and/or principal investigator(s):
Bonny C Gillis, M.D., Principal Investigator, Affiliation: Department of Anesthesiology UTHSCSA
Overall contact:
Bonny C Gillis, M.D., Phone: 2108447467, Email: gillis@uthscsa.edu
Summary
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.
Clinical Details
Official title: Effects of Low Dose Ketamine Given at Induction of Anesthesia on Postoperative Mood in Patients With Depressive Symptoms
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Primary outcome: Depression score using Goldberg Depression Screening test
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- History of or current depression scoring five or above on Goldberg Depression Screen
Exclusion Criteria:
- Uncontrolled hypertension, allergy to ketamine,pregnancy
Locations and Contacts
Bonny C Gillis, M.D., Phone: 2108447467, Email: gillis@uthscsa.edu Additional Information
Starting date: June 2015
Last updated: April 28, 2015
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