The Impact of Perioperative Ketamine Infusion on Surgical Recovery

January 10, 2025 updated by: Britany Lynn Raymond, MD, Vanderbilt University Medical Center

The Effect and Contribution of a Perioperative Ketamine Infusion in an Established Enhanced Recovery Pathway

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Opioids are powerful analgesic medications that can reduce pain through action at the mu receptor. Unfortunately, activation of the mu receptor also results in undesirable side effects, such as respiratory depression, sedation, bowel ileus, nausea, itching, and tolerance. Therefore, in order to effectively treat pain with the least amount of opioids required, a multi-modal approach must include medications with different mechanisms of actions at alternative receptors. Some examples of non-narcotic pain medications include acetaminophen (Tylenol), anti-inflammatories (NSAIDS), muscle relaxants, local anesthetics, gabapentinoids (Lyrica), and ketamine, to name a few. 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' or enhanced recovery after surgery (ERAS). 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. Ultimately, the investigators aim to perform a series of randomized controlled trials in which we isolate each component of the pathway to investigate its effects on length of stay, total opioid consumption, and surgical outcomes. The investigators will begin with studying ketamine.

Study Type

Interventional

Enrollment (Actual)

1570

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketamine
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
Participants in the ketamine arm will receive intraoperative and postoperative ketamine.
Other Names:
  • Ketalar
Placebo Comparator: Saline
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
Participants in the placebo arm will receive intraoperative and postoperative saline.
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Stay
Time Frame: From surgery start until discharge, typically 3-5 days
The participants length of stay, from anesthesia beginning to discharge, measured in days
From surgery start until discharge, typically 3-5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Consumption of Inpatient Opioids
Time Frame: From hospital admission until discharge, typically 3-5 days
Inpatient opioid consumption measured in morphine milligram equivalents
From hospital admission until discharge, typically 3-5 days
Number of Participants With Ileus
Time Frame: From hospital admission until discharge, typically 3-5 days
Number of participants reporting ileus requiring gastric decompression as defined by orogastric or nasogastric tube placement in the postoperative period.
From hospital admission until discharge, typically 3-5 days
Number of Participants Who Encounter Rapid Response Team Activation
Time Frame: From hospital admission until discharge, typically 3-5 days
Number of participants who encounter rapid response team activation within 72 hours post-operation. This is as a binary outcome
From hospital admission until discharge, typically 3-5 days
Number of Participants Who Experienced ICU Transfer
Time Frame: From hospital admission until discharge, typically 3-5 days
Number of participants who experienced transfer to ICU. This is as a binary outcome
From hospital admission until discharge, typically 3-5 days
Number of Participants Who Experienced Adverse Side Effects
Time Frame: From hospital admission until discharge, typically 3-5 days
Total number of side effects (hallucination, sedation, lightheadedness, patient request) as adverse reactions requiring early cessation.
From hospital admission until discharge, typically 3-5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Britany L Raymond, MD, Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2021

Primary Completion (Actual)

January 26, 2024

Study Completion (Actual)

February 1, 2024

Study Registration Dates

First Submitted

November 6, 2020

First Submitted That Met QC Criteria

November 6, 2020

First Posted (Actual)

November 12, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 10, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200210

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators do not plan to share individual participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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