Effects of Low Dose Ketamine Given at Induction of Anesthesia on Postoperative Mood in Patients With Depressive Symptoms
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|ClinicalTrials.gov Identifier: NCT02422303|
Recruitment Status : Terminated
First Posted : April 21, 2015
Results First Posted : February 15, 2018
Last Update Posted : February 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Depression Major Depressive Disorder||Drug: ketamine||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Effects of Low Dose Ketamine Given at Induction of Anesthesia on Postoperative Mood in Patients With Depressive Symptoms|
|Study Start Date :||December 2015|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
Active Comparator: Ketamine Group
This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia.
Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia.
Other Name: ketalar
No Intervention: No ketamine group
This group will not receive ketamine at induction of general anesthesia.
- 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
- just a little
- quite a lot
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02422303
|United States, Texas|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Bonny C Gillis, M.D.||Department of Anesthesiology UTHSCSA|