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Ketamine hydrochloride, an anesthetic medication, has been demonstrated to acutely and rapidly improve depressive symptoms but not yet been adequately studied for this effect when used as part of a general anesthetic for surgery. This proposed single-centre, double-blinded, randomized clinical trial of adult patients with depression presenting for gynecologic surgery would compare severity of depressive symptoms between patients receiving and not receiving ketamine as part of their general anesthetic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | Active Comparator | As part of the patient's anesthetic induction, they will receive propofol and fentanyl. |
|
| Ketamine Arm | Active Comparator | As part of the patient's anesthetic induction, they will receive propofol, fentanyl, as well as ketamine hydrochloride. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine Hydrochloride | Drug | As part of anesthetic induction, the addition of ketamine hydrochloride 0.5mg/kg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Depression Severity | Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and >34 is severe depression. | At time of discharge from post-anesthetic care unit, until 3 hours post operatvie |
| Depression Severity | Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and >34 is severe depression. | 72 hours post-operative |
| Depression Severity | Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and >34 is severe depression. | 7-days post-operative |
| Depression Severity | Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and >34 is severe depression. | 30-days post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score | Verbally reported numeric pain score (out of 10) | Pre-operatively |
| Pain Score | Verbally reported numeric pain score (out of 10) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Gamble, MD | Contact | 306-655-1183 | j_gamble@yahoo.com | |
| Jordon Steeg, MD | Contact | 306-222-9782 | jordon.steeg@usask.ca |
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Gamble, MD | University of Saskatchewan | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12088953 | Background | Kudoh A, Takahira Y, Katagai H, Takazawa T. Small-dose ketamine improves the postoperative state of depressed patients. Anesth Analg. 2002 Jul;95(1):114-8, table of contents. doi: 10.1097/00000539-200207000-00020. | |
| 25010396 | Background | McGirr A, Berlim MT, Bond DJ, Fleck MP, Yatham LN, Lam RW. A systematic review and meta-analysis of randomized, double-blind, placebo-controlled trials of ketamine in the rapid treatment of major depressive episodes. Psychol Med. 2015 Mar;45(4):693-704. doi: 10.1017/S0033291714001603. Epub 2014 Jul 10. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D015742 | Propofol |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Propofol | Drug | As part of the patient's anesthetic induction, they will receive propofol. |
|
| Fentanyl | Drug | As part of the patient's anesthetic induction, they will receive fentanyl. |
|
| Upon discharge from PACU, up to 3 hours postoperative |
| Pain Score | Verbally reported numeric pain score (out of 10) | 72 hours post-opertaive |
| Pain Score | Verbally reported numeric pain score (out of 10) | 7-days post-op |
| Pain Score | Verbally reported numeric pain score (out of 10) | 30-days post-op |
| Analgesia use | Morphine equivalents (in milligrams) | Pre-operatively |
| Analgesia use | Morphine equivalents (in milligrams) | Upon discharge from PACU, up to 3 hours postoperative |
| Analgesia use | Morphine equivalents (in milligrams) | 72 hours post-operative |
| Analgesia use | Morphine equivalents (in milligrams) | 7-days post-operative |
| Analgesia use | Morphine equivalents (in milligrams) | 30-days post-operative |
| 25698228 | Background | Lee EE, Della Selva MP, Liu A, Himelhoch S. Ketamine as a novel treatment for major depressive disorder and bipolar depression: a systematic review and quantitative meta-analysis. Gen Hosp Psychiatry. 2015 Mar-Apr;37(2):178-84. doi: 10.1016/j.genhosppsych.2015.01.003. Epub 2015 Jan 15. |
| 25038867 | Background | Fond G, Loundou A, Rabu C, Macgregor A, Lancon C, Brittner M, Micoulaud-Franchi JA, Richieri R, Courtet P, Abbar M, Roger M, Leboyer M, Boyer L. Ketamine administration in depressive disorders: a systematic review and meta-analysis. Psychopharmacology (Berl). 2014 Sep;231(18):3663-76. doi: 10.1007/s00213-014-3664-5. Epub 2014 Jul 20. |
| 21557878 | Background | Larkin GL, Beautrais AL. A preliminary naturalistic study of low-dose ketamine for depression and suicide ideation in the emergency department. Int J Neuropsychopharmacol. 2011 Sep;14(8):1127-31. doi: 10.1017/S1461145711000629. Epub 2011 May 5. |
|
| 24688759 | Background | Caddy C, Giaroli G, White TP, Shergill SS, Tracy DK. Ketamine as the prototype glutamatergic antidepressant: pharmacodynamic actions, and a systematic review and meta-analysis of efficacy. Ther Adv Psychopharmacol. 2014 Apr;4(2):75-99. doi: 10.1177/2045125313507739. |
| 10686270 | Background | Berman RM, Cappiello A, Anand A, Oren DA, Heninger GR, Charney DS, Krystal JH. Antidepressant effects of ketamine in depressed patients. Biol Psychiatry. 2000 Feb 15;47(4):351-4. doi: 10.1016/s0006-3223(99)00230-9. |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |