Effects of Methadone and Hydromorphone on Heart Rhythm After Surgery
Official title: Effect of Methadone and Hydromorphone on the QT Interval After Anesthesia and Surgery
Run by Endeavor Health · NCT03893734 · Data updated 2026-11-12
This study tests how two pain medications, methadone and hydromorphone, affect heart rhythm in patients after surgery to see if they cause any problems.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 140 (estimated) |
| Sponsor | Endeavor Health Academic / other |
| Locations | 1 site (Evanston, Illinois) |
| Status | Recruiting |
| Started | May 1, 2018 |
| Main results expected | August 12, 2020 |
| Study ends | December 23, 2020 |
| Registry record updated | September 13, 2019 |
| Trial ID | NCT03893734 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients scheduled for elective surgeries requiring general anesthesia and experiencing moderate-to-severe postoperative pain.
✕Probably not a fit
Patients with a history of arrhythmias, pacemakers, or significant preoperative pain requiring opioid treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates how methadone and hydromorphone, two pain medications, affect the QT interval on the electrocardiogram (EKG) in patients after undergoing general anesthesia and surgery. The study aims to understand the risk of QT prolongation, which can lead to serious heart arrhythmias, particularly in patients with certain risk factors. By monitoring the EKG of patients receiving these medications, the trial seeks to identify any significant changes in heart rhythm that may occur postoperatively.
Why it matters
Potential benefit: If successful, this study could help improve the safety of pain management in surgical patients by identifying risks associated with QT prolongation.
How similar studies have gone: While there have been studies on QT prolongation related to various medications, the specific combination of methadone and hydromorphone in this context is less explored, making this approach relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients presenting for elective surgical cases requiring general anesthesia and associated with moderate-to-severe postoperative pain will be eligible for enrollment. Exclusion Criteria: * History of arrhythmias, pacemaker, or defibrillator * Allergy to methadone or hydromorphone * Preoperative altered mental status * Abnormal serum electrolyte values * Existence of significant valvular disease or cardiac rhythm other than sinus * Significant preoperative pain requiring treatment with opioids or recent history of opioid abuse
Where it's running
-
NorthShore University HealthSystem
Evanston, Illinois, United States Recruiting
Study contacts
- Principal investigator: Glenn S Murphy, MD — Endeavor Health
- Study coordinator: Lucyna W Klatzco
- Email: lklatzco@northshore.org
- Phone: 264-364-7272
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.