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. 2023 Jun 30;23(1):227.
doi: 10.1186/s12871-023-02177-y.

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

Britany L Raymond  1 , Brian F S Allen  2 , Robert E Freundlich  2   3 , Crystal G Parrish  2 , Jennifer E Jayaram  2 , Jonathan P Wanderer  2 , Todd W Rice  3 , Christopher J Lindsell  3 , Kevin H Scharfman  4 , Mary L Dear  3 , Yue Gao  3 , William D Hiser  3 , Matthew D McEvoy  2 ; Vanderbilt Learning Healthcare System Platform Investigators
Collaborators, Affiliations

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

Britany L Raymond et al. BMC Anesthesiol. .

Abstract

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 h) 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: NCT04625283, Pre-results.

Keywords: ERAS; Enhanced recovery after surgery; Enhanced recovery pathways; Ketamine; Length of stay; Multimodal analgesia.

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Conflict of interest statement

MM serves on the scientific advisory board for Takeda Pharmaceuticals, and the role is unrelated to this work.RF owns stock in 3 M, and he serves as a consultant for Oak Hill Clinical Informatics and Phillips. He declares no conflicts of interest with this work.CL owns stock in Bioscape Digital, which is unrelated to this work.TR has relations with Cumberland Pharmaceuticals, Inc. (Director of Medical Affairs), Cytovale, Inc. (Consultant), and Sanofi, Inc. (Member of the Data Safety and Monitoring Board). No conflicts or relationships are related to this work. All other authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Compliance dashboard monitoring our institution’s adherence to the colorectal ERAS protocol, by phase of care
Fig. 2
Fig. 2
Compliance dashboard monitoring our institution’s adherence rates to preoperative elements of the colorectal ERAS protocol
See this image and copyright information in PMC

Update of

References

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