RECRUITING

Effect of Methadone and Hydromorphone on the QT Interval After Anesthesia and Surgery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A number of drugs used in the perioperative period may cause prolongation of the QT interval on the electrocardiogram (EKG). These drugs include inhalational agents, antiemetic agents, pain medications, and drugs used to reverse the effects of muscle relaxants. Approximately 80% of patients undergoing a general anesthetic will demonstrate significant prolongation of the QT interval on the EKG in the postanesthesia care unit (PACU) following surgery. The concern with QT interval prolongation is that it can result in a potentially lethal ventricular arrhythmia termed torsade des pointes. Despite the concurrent use of several of these medications in a typical general anesthetic, torsade des pointes is a rare event in the perioperative period. In the past decade, the use of intravenous methadone as part of a balanced anesthetic technique has increased significantly. A single dose provided at induction of anesthesia can provide prolonged (24-48 hours) relief from pain. Studies in patients receiving long-term treatment with methadone for addiction therapy or chronic pain have revealed that these patients are at risk for QT prolongation, torsade des pointe, and cardiac death. However, the effect of a single intravenous dose of methadone used in the operating room on the QT interval is uncertain. The aim of this randomized clinical trial is to compare the impact of methadone, when compared to the more commonly-used opioid hydromorphone, on QT prolongation measured with a 12-lead EKG in the PACU and on postoperative day 1. We hypothesize that methadone will not result in significant QT prolongation when used as part of a standardized general anesthetic.

Official Title

Effect of Methadone and Hydromorphone on the QT Interval After Anesthesia and Surgery

Quick Facts

Study Start:2018-05-01
Study Completion:2020-12-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03893734

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * All patients presenting for elective surgical cases requiring general anesthesia and associated with moderate-to-severe postoperative pain will be eligible for enrollment.
  1. * History of arrhythmias, pacemaker, or defibrillator
  2. * Allergy to methadone or hydromorphone
  3. * Preoperative altered mental status
  4. * Abnormal serum electrolyte values
  5. * Existence of significant valvular disease or cardiac rhythm other than sinus
  6. * Significant preoperative pain requiring treatment with opioids or recent history of opioid abuse

Contacts and Locations

Study Contact

Lucyna W Klatzco
CONTACT
264-364-7272
lklatzco@northshore.org

Principal Investigator

Glenn S Murphy, MD
PRINCIPAL_INVESTIGATOR
NorthShore University HealthSystem

Study Locations (Sites)

NorthShore University HealthSystem
Evanston, Illinois, 60201
United States

Collaborators and Investigators

Sponsor: NorthShore University HealthSystem

  • Glenn S Murphy, MD, PRINCIPAL_INVESTIGATOR, NorthShore University HealthSystem

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 Registration Dates

Study Start Date2018-05-01
Study Completion Date2020-12-23

Study Record Updates

Study Start Date2018-05-01
Study Completion Date2020-12-23

Terms related to this study

Additional Relevant MeSH Terms

  • EKG-QT Prolongation