Effects of Low Dose Ketamine Given at Induction of Anesthesia on Postoperative Mood in Patients With Depressive Symptoms
- Registration Number
- NCT02422303
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 12
- History of or current depression scoring five or above on Goldberg Depression Screen
- Uncontrolled hypertension, allergy to ketamine,pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ketamine Group ketamine This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia.
- Primary Outcome Measures
Name Time Method Depression Score Using Goldberg Depression Screening Test 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital
🇺🇸San Antonio, Texas, United States