NCT03893734 Effect of Methadone and Hydromorphone on the QT Interval After Anesthesia and Surgery
| NCT ID | NCT03893734 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Endeavor Health |
| Condition | EKG-QT Prolongation |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2018-05-01 |
| Primary Completion | 2020-08-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 140 participants in total. It began in 2018-05-01 with a primary completion date of 2020-08-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Glenn S Murphy, MD
PRINCIPAL INVESTIGATOR
Endeavor Health
Frequently Asked Questions
Who can join the NCT03893734 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying EKG-QT Prolongation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03893734 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03893734 currently recruiting?
Yes, NCT03893734 is actively recruiting participants. Contact the research team at lklatzco@northshore.org for enrollment information.
Where is the NCT03893734 trial being conducted?
This trial is being conducted at Evanston, United States.
Who is sponsoring the NCT03893734 clinical trial?
NCT03893734 is sponsored by Endeavor Health. The principal investigator is Glenn S Murphy, MD at Endeavor Health. The trial plans to enroll 140 participants.