RecruitingPhase 4ketamine

Reducing Pain With Methadone and Ketamine in Liver Transplant

Sponsored by Lahey Clinic

NCT ID
NCT06868589
Target Enrollment
50 participants
Start Date
2025-06-30
Est. Completion
2026-09-01

About This Study

The goal of this clinical trial is to learn if using methadone and ketamine during an adult deceased donor liver transplant can help decrease pain after surgery. The main questions it aims to answer are: * What impact does using methadone and ketamine during a deceased donor liver transplant have on pain after surgery? * Does the use of methadone and ketamine also have an impact on mental confusion (delirium) after surgery? Researchers will compare the use of methadone and ketamine to standard of care to see if the two drugs work to decrease pain and impact delirium after liver transplant. Participants will: * Receive either methadone and ketamine or standard of care during their deceased donor liver transplant. * Allow researchers to follow medical care throughout inpatient stay.

Conditions Studied

Liver Transplantation

Interventions

  • Methadone
  • ketamine
  • Hydromorphone
  • fentanyl

Eligibility

Age:18 Years - N/A
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

* Adult patients ≥ 18 years of age at the time of LT.
* Undergoing LT from a deceased donor.
* Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion criteria:

* Living donor liver transplantation (LDLT).
* Split liver transplantation (isolated right or left lobe).
* Acute liver failure (ALF) as the indication for LT.
* Repeat (redo) liver transplant
* Simultaneous liver and kidney transplant (SLK)
* Sedation or high vasopressor use.
* Subject is intubated and/or mechanically ventilated prior to entering the operating room for LT.
* Severe Hepatic encephalopathy
* History of psychiatric disorders such as schizophrenia or bipolar mood disorders
* History of chronic opioid use, substance abuse or opioid maintenance therapies
* Any history of allergic reaction to any of the study drugs History of Brugadda, prolonged QT syndrome or QTc in preoperative setting
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
* Prisoner
* Pregnant person
* Operational Exclusion Criterion: Subjects will not be enrolled if study personnel required for protocol execution (e.g., study investigator, research staff or pharmacy staff) are unavailable at the time of transplantation.

Study Locations (2)

Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

Ryan Nazemian, MD, PhD
CONTACT
781-813-0389ryan.nazemian@lahey.org
Michael D Kaufman, MD
CONTACT
9787026578michael.kaufman@bilh.org
View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source