The Impact of Perioperative Ketamine Infusion on Surgical Recovery

NCT04625283 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 200210
• Study Type: interventional
• Target: 1,570
• Locations: 1 country
• Sites: 1

Brief Summary

In order to effectively treat surgical pain with the least amount of opioids required, a multi-modal approach must include medications with different mechanisms of actions at alternative receptors. In light of the opioid epidemic, medical providers at Vanderbilt University Medical Center (VUMC) are strategically combining these medications in a bundled pain-regimen after surgery. These regimens have been shown to decrease opioid consumption, improve surgical outcomes, and reduce hospital stays, thus coining the term 'enhanced recovery pathway'. The combination of these medications has an indisputable synergistic effect. However, it is unknown how each medication contributes individually to the overall efficacy of the pathway. This study will examine the effects of ketamine, within the constructs of a multimodal pain regimen, on a) length of stay, b) opioid consumption, and c) surgical outcomes after major abdominal surgery.

Conditions

Opioid Use; Enhanced Recovery After Surgery; Anesthesia; Ketamine; Pain, Postoperative

Keywords

ERAS; Enhanced Recovery After Surgery; Ketamine; Opioid; Learning Healthcare System

Outcome Measures

Primary Outcomes (1)

• Length of Stay

  The participants length of stay, from anesthesia beginning to discharge, measured in days

  From surgery start until discharge, typically 3-5 days

Secondary Outcomes (5)

• Total Consumption of Inpatient Opioids

  From hospital admission until discharge, typically 3-5 days

• Number of Participants With Ileus

  From hospital admission until discharge, typically 3-5 days

• Number of Participants Who Encounter Rapid Response Team Activation

  From hospital admission until discharge, typically 3-5 days

• Number of Participants Who Experienced ICU Transfer

  From hospital admission until discharge, typically 3-5 days

• Number of Participants Who Experienced Adverse Side Effects

  From hospital admission until discharge, typically 3-5 days

Study Arms (2)

Ketamine

EXPERIMENTAL

Participants in this arm will receive intraoperative ketamine bolus (0.5mg/kg) followed by continuous infusion 5 mcg/kg/min and also will receive postoperative ketamine infusion (2.5 mcg/kg/min, up to 100kg max) for 48 hours.

Drug: Ketamine

Saline

PLACEBO COMPARATOR

Participants in this arm will receive an equivalent volume of intraoperative saline bolus followed by continuous saline infusion and also will receive postoperative saline infusion for 48 hours.

Drug: Placebo

Interventions

Ketamine DRUG

Participants in the ketamine arm will receive intraoperative and postoperative ketamine.

Also known as: Ketalar

Ketamine

Placebo DRUG

Participants in the placebo arm will receive intraoperative and postoperative saline.

Also known as: Saline

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or greater
• presenting at VUMC for abdominal surgery on the colorectal, ventral hernia or surgical oncology services on a weekday.

You may not qualify if:

• allergy or contraindication to ketamine
• unable or refuse to receive a neuraxial or regional nerve block
• patient refusal
• direct transfer from operating room to intensive care unit with endotracheal tube placed
• treating team elects to exclude the patient prior to study drug administration
• abortion of planned surgical procedure

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (24)

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  PMID: 30745263 BACKGROUND

• Raymond BL, Allen BFS, Freundlich RE, McEvoy MD, Parrish CG, Ruble SR, Scharfman KH, Wanderer JP, Gao Y, Choi L, Dear ML, Master H, Rice TW, Kertai MD; Vanderbilt Learning Healthcare System Platform Investigators. IMpact of PerioperAtive KeTamine on Enhanced Recovery After abdominal Surgery (IMPAKT ERAS): a pragmatic randomised single-cluster trial. Br J Anaesth. 2025 Dec;135(6):1770-1778. doi: 10.1016/j.bja.2025.08.001. Epub 2025 Sep 3.

  PMID: 40903379 DERIVED

• Raymond BL, Allen BFS, Freundlich RE, Parrish CG, Jayaram JE, Wanderer JP, Rice TW, Lindsell CJ, Scharfman KH, Dear ML, Gao Y, Hiser WD, McEvoy MD; Vanderbilt Learning Healthcare System Platform Investigators. The IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery (IMPAKT ERAS): protocol for a pragmatic, randomized, double-blinded, placebo-controlled trial. BMC Anesthesiol. 2023 Jun 30;23(1):227. doi: 10.1186/s12871-023-02177-y.

  PMID: 37391729 DERIVED

• Raymond BL, Allen BFS, Freundlich RE, Parrish CG, Jayaram JE, Wanderer JP, Rice TW, Lindsell CJ, Scharfman KH, Dear ML, Gao Y, Hiser WD, McEvoy MD. The IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery (IMPAKT ERAS): protocol for a pragmatic, randomized, double-blinded, placebo-controlled trial. Res Sq [Preprint]. 2023 Mar 24:rs.3.rs-2639840. doi: 10.21203/rs.3.rs-2639840/v1.

  PMID: 36993617 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketamine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Britany Martin
• Organization: Vanderbilt University Medical Center

britany.l.raymond@vumc.org

+1 (615)322-8476

Study Officials

• Britany L Raymond, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant Professor, Department of Anesthesiology

Model Details: This study will be performed as a pragmatic controlled clinical trial with parallel group assignment. Randomization will be in a cluster format.

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 12, 2020
• Study Start: April 12, 2021
• Primary Completion: January 26, 2024
• Study Completion: February 1, 2024
• Last Updated: February 4, 2025
• Results First Posted: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)