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Perioperative Ketamine for Enhanced Surgical Recovery

Phase 4

Waitlist Available

Led By Britany L Raymond, MD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years old or greater

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from surgery start until discharge, typically 3-5 days

Awards & highlights

Study Summary

This trial will study the effects of ketamine on reducing pain, opioid consumption, length of hospital stay, and surgical outcomes after major abdominal surgery.

Who is the study for?

This trial is for adults over 18 who are scheduled for weekday abdominal surgery at Vanderbilt University Medical Center, specifically in colorectal, ventral hernia or surgical oncology. It's not open to those allergic to ketamine, those who can't have nerve blocks, patients transferred directly to ICU with a breathing tube post-surgery, or if the medical team decides against it.Check my eligibility

What is being tested?

The study tests whether adding ketamine to a multi-drug pain regimen after major abdominal surgery can reduce opioid use and improve recovery outcomes. Participants will either receive ketamine or a placebo without knowing which one they get.See study design

What are the potential side effects?

Ketamine may cause side effects like changes in blood pressure and heart rate, dizziness, nausea, hallucinations or mood changes. However, its role within the multimodal pain regimen aims to minimize opioid use and related risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You must be at least 18 years old to participate in this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from surgery start until discharge, typically 3-5 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from surgery start until discharge, typically 3-5 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and from surgery start until discharge, typically 3-5 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Length of Stay

Secondary outcome measures

Incidence of Adverse Side Effects

Incidence of Surgical Outcomes - Gastrointestinal Complications

Incidence of Surgical Outcomes - ICU Transfer

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: KetamineExperimental Treatment1 Intervention

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.

Group II: SalinePlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketamine

FDA approved

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

855 Previous Clinical Trials

670,648 Total Patients Enrolled

Britany L Raymond, MDPrincipal InvestigatorVanderbilt University Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects are participating in this research effort?

"This research study has stopped recruiting patients, with the original posting dated April 12th 2021 and last update on November 3rd 2022. There are 720 clinical trials currently seeking participants that deal with pain postoperative treatments, as well as 105 studies related to Ketamine actively searching for test subjects."

Answered by AI

Has this research project opened its enrollment to new participants?

"The trial portal on clinicaltrials.gov indicates that this particular study, which was first advertised in April 2021 and last updated in November 2022, is no longer recruiting patients. Nevertheless, 825 other trials are presently looking to fill positions with suitable candidates."

Answered by AI

What potential risks may be associated with Ketamine use?

"There is sufficient evidence for the safety of ketamine, therefore it has been accorded a score of 3."

Answered by AI

What aims are this experimental endeavor seeking to accomplish?

"This research aims to assess Hospital Length of Stay between the commencement and completion of surgery, usually taking 3-5 days. Secondary objectives include ICU Transfer as a binary outcome, Return of Bowel Function measured in hours, and Inpatient Opioid Consumption expressed in Morphine Milligram Equivalents."

Answered by AI