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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine Group | Active Comparator | This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia. |
|
| No ketamine group | No Intervention | This group will not receive ketamine at induction of general anesthesia. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketamine | Drug | Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Depression Score Using Goldberg Depression Screening Test | 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
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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bonny C Gillis, M.D. | Department of Anesthesiology UTHSCSA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | San Antonio | Texas | 78229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16894061 | Background | Zarate CA Jr, Singh JB, Carlson PJ, Brutsche NE, Ameli R, Luckenbaugh DA, Charney DS, Manji HK. A randomized trial of an N-methyl-D-aspartate antagonist in treatment-resistant major depression. Arch Gen Psychiatry. 2006 Aug;63(8):856-64. doi: 10.1001/archpsyc.63.8.856. | |
| 24388038 | Background | Naughton M, Clarke G, O'Leary OF, Cryan JF, Dinan TG. A review of ketamine in affective disorders: current evidence of clinical efficacy, limitations of use and pre-clinical evidence on proposed mechanisms of action. J Affect Disord. 2014 Mar;156:24-35. doi: 10.1016/j.jad.2013.11.014. Epub 2013 Dec 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketamine Group | This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia. ketamine: Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia. |
| FG001 | No Ketamine Group | This group will not receive ketamine at induction of general anesthesia. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketamine Group | This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia. ketamine: Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia. |
| BG001 | No Ketamine Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Depression Score Using Goldberg Depression Screening Test | 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
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. | Participant data were destroyed at study termination, and no analysis was performed, since no longer available. | Posted | One week |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ketamine Group | This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia. ketamine: Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bonnie Gillis | University of Texas Health Science Center San Antonio | 210-567-4500 | gillis@uthscsa.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| 23689537 | Background | Martinowich K, Jimenez DV, Zarate CA Jr, Manji HK. Rapid antidepressant effects: moving right along. Mol Psychiatry. 2013 Aug;18(8):856-63. doi: 10.1038/mp.2013.55. Epub 2013 May 21. |
This group will not receive ketamine at induction of general anesthesia.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | No Ketamine Group | This group will not receive ketamine at induction of general anesthesia. |
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | No Ketamine Group | This group will not receive ketamine at induction of general anesthesia. | 0 | 6 | 0 | 6 |
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| D001523 |
| Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |