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The IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery (IMPAKT ERAS): protocol for a pragmatic, randomized, double-blinded, placebo-controlled trial

BACKGROUND: Multimodal analgesic strategies that reduce perioperative opioid consumption are well-supported in Enhanced Recovery After Surgery (ERAS) literature. However, the optimal analgesic regimen has not been established, as the contributions of each individual agent to the overall analgesic ef...

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Autores principales: Raymond, Britany L., Allen, Brian F.S., Freundlich, Robert E., Parrish, Crystal G., Jayaram, Jennifer E., Wanderer, Jonathan P., Rice, Todd W., Lindsell, Christopher J., Scharfman, Kevin H., Dear, Mary L., Gao, Yue, Hiser, William D., McEvoy, Matthew D.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Journal Experts 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10055550/
https://www.ncbi.nlm.nih.gov/pubmed/36993617
http://dx.doi.org/10.21203/rs.3.rs-2639840/v1
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author Raymond, Britany L.
Allen, Brian F.S.
Freundlich, Robert E.
Parrish, Crystal G.
Jayaram, Jennifer E.
Wanderer, Jonathan P.
Rice, Todd W.
Lindsell, Christopher J.
Scharfman, Kevin H.
Dear, Mary L.
Gao, Yue
Hiser, William D.
McEvoy, Matthew D.
author_facet Raymond, Britany L.
Allen, Brian F.S.
Freundlich, Robert E.
Parrish, Crystal G.
Jayaram, Jennifer E.
Wanderer, Jonathan P.
Rice, Todd W.
Lindsell, Christopher J.
Scharfman, Kevin H.
Dear, Mary L.
Gao, Yue
Hiser, William D.
McEvoy, Matthew D.
author_sort Raymond, Britany L.
collection PubMed
description BACKGROUND: Multimodal analgesic strategies that reduce perioperative opioid consumption are well-supported in Enhanced Recovery After Surgery (ERAS) literature. However, the optimal analgesic regimen has not been established, as the contributions of each individual agent to the overall analgesic efficacy with opioid reduction remains unknown. Perioperative ketamine infusions can decrease opioid consumption and opioid-related side effects. However, as opioid requirements are drastically minimized within ERAS models, the differential effects of ketamine within an ERAS pathway remain unknown. We aim to pragmatically investigate through a learning healthcare system infrastructure how the addition of a perioperative ketamine infusion to mature ERAS pathways affects functional recovery. METHODS: The IMPAKT ERAS trial (IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery) is a single center, pragmatic, randomized, blinded, placebo-controlled trial. 1544 patients undergoing major abdominal surgery will be randomly allocated to receive intraoperative and postoperative (up to 48 hours) ketamine versus placebo infusions as part of a perioperative multimodal analgesic regimen. The primary outcome is length of stay, defined as surgical start time until hospital discharge. Secondary outcomes will include a variety of in-hospital clinical end points derived from the electronic health record. DISCUSSION: We aimed to launch a large-scale, pragmatic trial that would easily integrate into routine clinical workflow. Implementation of a modified consent process was critical to preserving our pragmatic design, permitting an efficient, low-cost model without reliance on external study personnel. Therefore, we partnered with leaders of our Investigational Review Board to develop a novel, modified consent process and shortened written consent form that would meet all standard elements of informed consent, yet also allow clinical providers the ability to recruit and enroll patients during their clinical workflow. Our trial design has created a platform for subsequent pragmatic studies at our institution. TRIAL REGISTRATION NUMBER: NCT04625283, Pre-results
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spelling pubmed-100555502023-03-30 The IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery (IMPAKT ERAS): protocol for a pragmatic, randomized, double-blinded, placebo-controlled trial Raymond, Britany L. Allen, Brian F.S. Freundlich, Robert E. Parrish, Crystal G. Jayaram, Jennifer E. Wanderer, Jonathan P. Rice, Todd W. Lindsell, Christopher J. Scharfman, Kevin H. Dear, Mary L. Gao, Yue Hiser, William D. McEvoy, Matthew D. Res Sq Article BACKGROUND: Multimodal analgesic strategies that reduce perioperative opioid consumption are well-supported in Enhanced Recovery After Surgery (ERAS) literature. However, the optimal analgesic regimen has not been established, as the contributions of each individual agent to the overall analgesic efficacy with opioid reduction remains unknown. Perioperative ketamine infusions can decrease opioid consumption and opioid-related side effects. However, as opioid requirements are drastically minimized within ERAS models, the differential effects of ketamine within an ERAS pathway remain unknown. We aim to pragmatically investigate through a learning healthcare system infrastructure how the addition of a perioperative ketamine infusion to mature ERAS pathways affects functional recovery. METHODS: The IMPAKT ERAS trial (IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery) is a single center, pragmatic, randomized, blinded, placebo-controlled trial. 1544 patients undergoing major abdominal surgery will be randomly allocated to receive intraoperative and postoperative (up to 48 hours) ketamine versus placebo infusions as part of a perioperative multimodal analgesic regimen. The primary outcome is length of stay, defined as surgical start time until hospital discharge. Secondary outcomes will include a variety of in-hospital clinical end points derived from the electronic health record. DISCUSSION: We aimed to launch a large-scale, pragmatic trial that would easily integrate into routine clinical workflow. Implementation of a modified consent process was critical to preserving our pragmatic design, permitting an efficient, low-cost model without reliance on external study personnel. Therefore, we partnered with leaders of our Investigational Review Board to develop a novel, modified consent process and shortened written consent form that would meet all standard elements of informed consent, yet also allow clinical providers the ability to recruit and enroll patients during their clinical workflow. Our trial design has created a platform for subsequent pragmatic studies at our institution. TRIAL REGISTRATION NUMBER: NCT04625283, Pre-results American Journal Experts 2023-03-24 /pmc/articles/PMC10055550/ /pubmed/36993617 http://dx.doi.org/10.21203/rs.3.rs-2639840/v1 Text en https://creativecommons.org/licenses/by/4.0/This work is licensed under a Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/) , which allows reusers to distribute, remix, adapt, and build upon the material in any medium or format, so long as attribution is given to the creator. The license allows for commercial use.
spellingShingle Article
Raymond, Britany L.
Allen, Brian F.S.
Freundlich, Robert E.
Parrish, Crystal G.
Jayaram, Jennifer E.
Wanderer, Jonathan P.
Rice, Todd W.
Lindsell, Christopher J.
Scharfman, Kevin H.
Dear, Mary L.
Gao, Yue
Hiser, William D.
McEvoy, Matthew D.
The IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery (IMPAKT ERAS): protocol for a pragmatic, randomized, double-blinded, placebo-controlled trial
title The IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery (IMPAKT ERAS): protocol for a pragmatic, randomized, double-blinded, placebo-controlled trial
title_full The IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery (IMPAKT ERAS): protocol for a pragmatic, randomized, double-blinded, placebo-controlled trial
title_fullStr The IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery (IMPAKT ERAS): protocol for a pragmatic, randomized, double-blinded, placebo-controlled trial
title_full_unstemmed The IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery (IMPAKT ERAS): protocol for a pragmatic, randomized, double-blinded, placebo-controlled trial
title_short The IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery (IMPAKT ERAS): protocol for a pragmatic, randomized, double-blinded, placebo-controlled trial
title_sort impact of perioperative ketamine on enhanced recovery after abdominal surgery (impakt eras): protocol for a pragmatic, randomized, double-blinded, placebo-controlled trial
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10055550/
https://www.ncbi.nlm.nih.gov/pubmed/36993617
http://dx.doi.org/10.21203/rs.3.rs-2639840/v1
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