Protocol for the Ketamine for Postoperative Avoidance of Depressive Symptoms (K-PASS) feasibility study: A randomized clinical trial [version 1; peer review: 2 approved]
Background: Postoperative depressive symptoms are associated with pain, readmissions, death, and other undesirable outcomes. Ketamine produces rapid but transient antidepressant effects in the perioperative setting. Longer infusions confer lasting antidepressant activity in patients with treatment-r...
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| Format: | Article |
| Language: | English |
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F1000 Research Ltd
2022-05-01
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| Online Access: | https://f1000research.com/articles/11-510/v1 |
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| author | Jon T. Willie Nuri B. Farber Ben J.A. Palanca Julie A. Schweiger Bradley A. Fritz Bethany R. Tellor Pennington |
| author_facet | Jon T. Willie Nuri B. Farber Ben J.A. Palanca Julie A. Schweiger Bradley A. Fritz Bethany R. Tellor Pennington |
| author_sort | Jon T. Willie |
| collection | DOAJ |
| description | Background: Postoperative depressive symptoms are associated with pain, readmissions, death, and other undesirable outcomes. Ketamine produces rapid but transient antidepressant effects in the perioperative setting. Longer infusions confer lasting antidepressant activity in patients with treatment-resistant depression, but it is unknown whether a similar approach may produce a lasting antidepressant effect after surgery. This protocol describes a pilot study that will assess the feasibility of conducting a larger scale randomized clinical trial addressing this knowledge gap. Methods: This single-center, double-blind, placebo-controlled pilot trial involves the enrollment of 32 patients aged 18 years or older with a history of depression scheduled for surgery with planned intensive care unit admission. On the first day following surgery and extubation, participants will be randomized to an intravenous eight-hour infusion of either ketamine (0.5 mg kg-1 over 10 minutes followed by a continuous rate of 0.3 mg kg-1 h-1) or an equal volume of normal saline. Depressive symptoms will be quantified using the Montgomery-Asberg Depression Rating Scale preoperatively and serially up to 14 days after the infusion. To detect ketamine-induced changes on overnight sleep architecture, a wireless headband will be used to record electroencephalograms preoperatively, during the study infusion, and after infusion. The primary feasibility endpoints will include the fraction of patients approached who enroll, the fraction of randomized patients who complete the study infusion, and the fraction of randomized patients who complete outcome data collection. Conclusions: This pilot study will evaluate the feasibility of a future large comparative effectiveness trial of ketamine to reduce depressive symptoms in postsurgical patients. Registration: K-PASS is registered on ClinicalTrials.gov: NCT05233566; registered February 10, 2022. |
| first_indexed | 2024-03-12T22:28:06Z |
| format | Article |
| id | doaj.art-e23eb81bcc6d4c1d99ef0b49153e018e |
| institution | Directory Open Access Journal |
| issn | 2046-1402 |
| language | English |
| last_indexed | 2024-03-12T22:28:06Z |
| publishDate | 2022-05-01 |
| publisher | F1000 Research Ltd |
| record_format | Article |
| series | F1000Research |
| spelling | doaj.art-e23eb81bcc6d4c1d99ef0b49153e018e2023-07-22T00:00:01ZengF1000 Research LtdF1000Research2046-14022022-05-0111133398Protocol for the Ketamine for Postoperative Avoidance of Depressive Symptoms (K-PASS) feasibility study: A randomized clinical trial [version 1; peer review: 2 approved]Jon T. Willie0Nuri B. Farber1https://orcid.org/0000-0003-3178-1877Ben J.A. Palanca2Julie A. Schweiger3Bradley A. Fritz4https://orcid.org/0000-0002-7239-8877Bethany R. Tellor Pennington5Department of Neurosurgery, Washington University in St. Louis, St. Louis, Missouri, 63110, USADepartment of Psychiatry, Washington University in St. Louis, St. Louis, Missouri, 63110, USADepartment of Anesthesiology, Washington University in St. Louis, St. Louis, Missouri, 63110, USADepartment of Psychiatry, Washington University in St. Louis, St. Louis, Missouri, 63110, USADepartment of Anesthesiology, Washington University in St. Louis, St. Louis, Missouri, 63110, USADepartment of Anesthesiology, Washington University in St. Louis, St. Louis, Missouri, 63110, USABackground: Postoperative depressive symptoms are associated with pain, readmissions, death, and other undesirable outcomes. Ketamine produces rapid but transient antidepressant effects in the perioperative setting. Longer infusions confer lasting antidepressant activity in patients with treatment-resistant depression, but it is unknown whether a similar approach may produce a lasting antidepressant effect after surgery. This protocol describes a pilot study that will assess the feasibility of conducting a larger scale randomized clinical trial addressing this knowledge gap. Methods: This single-center, double-blind, placebo-controlled pilot trial involves the enrollment of 32 patients aged 18 years or older with a history of depression scheduled for surgery with planned intensive care unit admission. On the first day following surgery and extubation, participants will be randomized to an intravenous eight-hour infusion of either ketamine (0.5 mg kg-1 over 10 minutes followed by a continuous rate of 0.3 mg kg-1 h-1) or an equal volume of normal saline. Depressive symptoms will be quantified using the Montgomery-Asberg Depression Rating Scale preoperatively and serially up to 14 days after the infusion. To detect ketamine-induced changes on overnight sleep architecture, a wireless headband will be used to record electroencephalograms preoperatively, during the study infusion, and after infusion. The primary feasibility endpoints will include the fraction of patients approached who enroll, the fraction of randomized patients who complete the study infusion, and the fraction of randomized patients who complete outcome data collection. Conclusions: This pilot study will evaluate the feasibility of a future large comparative effectiveness trial of ketamine to reduce depressive symptoms in postsurgical patients. Registration: K-PASS is registered on ClinicalTrials.gov: NCT05233566; registered February 10, 2022.https://f1000research.com/articles/11-510/v1Depression Feasibility Ketamine Protocol Randomized Clinical Trial Surgeryeng |
| spellingShingle | Jon T. Willie Nuri B. Farber Ben J.A. Palanca Julie A. Schweiger Bradley A. Fritz Bethany R. Tellor Pennington Protocol for the Ketamine for Postoperative Avoidance of Depressive Symptoms (K-PASS) feasibility study: A randomized clinical trial [version 1; peer review: 2 approved] F1000Research Depression Feasibility Ketamine Protocol Randomized Clinical Trial Surgery eng |
| title | Protocol for the Ketamine for Postoperative Avoidance of Depressive Symptoms (K-PASS) feasibility study: A randomized clinical trial [version 1; peer review: 2 approved] |
| title_full | Protocol for the Ketamine for Postoperative Avoidance of Depressive Symptoms (K-PASS) feasibility study: A randomized clinical trial [version 1; peer review: 2 approved] |
| title_fullStr | Protocol for the Ketamine for Postoperative Avoidance of Depressive Symptoms (K-PASS) feasibility study: A randomized clinical trial [version 1; peer review: 2 approved] |
| title_full_unstemmed | Protocol for the Ketamine for Postoperative Avoidance of Depressive Symptoms (K-PASS) feasibility study: A randomized clinical trial [version 1; peer review: 2 approved] |
| title_short | Protocol for the Ketamine for Postoperative Avoidance of Depressive Symptoms (K-PASS) feasibility study: A randomized clinical trial [version 1; peer review: 2 approved] |
| title_sort | protocol for the ketamine for postoperative avoidance of depressive symptoms k pass feasibility study a randomized clinical trial version 1 peer review 2 approved |
| topic | Depression Feasibility Ketamine Protocol Randomized Clinical Trial Surgery eng |
| url | https://f1000research.com/articles/11-510/v1 |
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