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The Impact of Perioperative Ketamine Infusion on Surgical Recovery

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ClinicalTrials.gov Identifier: NCT04625283
Recruitment Status : Not yet recruiting
First Posted : November 12, 2020
Last Update Posted : March 11, 2021
Sponsor:
Information provided by (Responsible Party):
Britany Lynn Raymond, MD, Vanderbilt University Medical Center

Tracking Information
First Submitted Date  ICMJE November 6, 2020
First Posted Date  ICMJE November 12, 2020
Last Update Posted Date March 11, 2021
Estimated Study Start Date  ICMJE April 2021
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2020)
Hospital Length of Stay [ Time Frame: From hospital admission until discharge, typically 3-5 days ]
The participants total hospital length of stay measured in days
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2020)
  • Total consumption of inpatient opioids [ Time Frame: From hospital admission until discharge, typically 3-5 days ]
    Inpatient opioid consumption measured in morphine milligram equivalents
  • Pain scores [ Time Frame: Inpatient baseline day through inpatient day 3 ]
    Numerical pain scores, ranging from 0 to 10 with 0 being no pain and 10 being worse pain possible
  • Incidence of Surgical Outcomes - Return of bowel function [ Time Frame: From hospital admission until discharge, typically 3-5 days ]
    Return of bowel function measured in hours
  • Incidence of Surgical Outcomes - Gastrointestinal Complications [ Time Frame: From hospital admission until discharge, typically 3-5 days ]
    Incidence of ileus and/or nausea
  • Incidence of Surgical Outcomes - Rapid Response [ Time Frame: From hospital admission until discharge, typically 3-5 days ]
    Rapid response as a binary outcome
  • Incidence of Surgical Outcomes - ICU Transfer [ Time Frame: From hospital admission until discharge, typically 3-5 days ]
    Transfer to ICU as a binary outcome
  • Incidence of Adverse Side Effects [ Time Frame: From hospital admission until discharge, typically 3-5 days ]
    Total incidence of side effects (hallucination, sedation, lightheadedness, patient request) as adverse reactions requiring early cessation.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Impact of Perioperative Ketamine Infusion on Surgical Recovery
Official Title  ICMJE The Effect and Contribution of a Perioperative Ketamine Infusion in an Established Enhanced Recovery Pathway
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, c) pain scores, and d) surgical outcomes after major abdominal surgery.
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, pain scores, and surgical outcomes. The investigators will begin with studying ketamine.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This study will be performed as a pragmatic controlled clinical trial with parallel group assignment. Randomization will be in a cluster format.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Opioid Use
  • Enhanced Recovery After Surgery
  • Anesthesia
  • Ketamine
  • Pain, Postoperative
Intervention  ICMJE
  • Drug: Ketamine
    Participants in the ketamine arm will receive intraoperative and postoperative ketamine.
    Other Name: Ketalar
  • Drug: Placebo
    Participants in the placebo arm will receive intraoperative and postoperative saline.
    Other Name: Saline
Study Arms  ICMJE
  • 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 mg/kg/min, up to 100kg max) for 48 hours.
    Intervention: Drug: Ketamine
  • 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.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 6, 2020)
1600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2022
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • allergy or contraindication to ketamine
  • unable or refuse to receive a regional nerve block
  • patient refusal
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Britany L Raymond, MD 615-322-8476 britany.l.raymond@vumc.org
Contact: Matthew D McEvoy, MD 615-936-5194 matthew.d.mcevoy@vumc.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04625283
Other Study ID Numbers  ICMJE 200210
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The investigators do not plan to share individual participant data.
Responsible Party Britany Lynn Raymond, MD, Vanderbilt University Medical Center
Study Sponsor  ICMJE Vanderbilt University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Britany L Raymond, MD Vanderbilt University Medical Center
PRS Account Vanderbilt University Medical Center
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP