Effects of Low Dose Ketamine Given at Induction of Anesthesia on Postoperative Mood in Patients With Depressive Symptoms
Brief Summary
Condition or Disease
- Depression
- Major Depressive Disorder
Phase
Study Design
Study type: | Interventional |
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Status: | Terminated |
Study results: | Has Results |
Age: | 18 Years to 65 Years (Adult, Older Adult) |
Enrollment: | 12 () |
Funded by: | Other |
Masking |
Clinical Trial Dates
Start date: | Dec 15, 2022 | |
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Primary Completion: | Sep 16, 2022 | |
Completion Date: | Sep 16, 2022 | |
Study First Posted: | Apr 21, 2015 | |
Results First Posted: | Feb 15, 2018 | |
Last Updated: | Feb 15, 2018 |
Sponsors / Collaborators
Location
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 Criteria
Sex: | Female |
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Minimum Age: | 18 |
Maximum Age: | 65 |
More Details
NCT Number: | NCT02422303 |
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Other IDs: | HSC20150248H |
Study URL: | https://ClinicalTrials.gov/show/NCT02422303 |