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Opioid

methadone group for Long QT Syndrome

Phase 4
Recruiting
Led By Glenn S Murphy, MD
Research Sponsored by NorthShore University HealthSystem
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* All patients presenting for elective surgical cases requiring general anesthesia and associated with moderate-to-severe postoperative pain will be eligible for enrollment.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes after post anesthesia care unit admission
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
Pivotal Trial

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.

Eligible Conditions
  • Long QT Syndrome

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes after postanesthesia care unit admission
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes after postanesthesia care unit admission for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
QT prolongation on the EKG 30 minutes after postanesthesia care unit admission
Secondary study objectives
Level of pain on a 0-10 scale on the morning of postoperative day one
Level of pain on on a 0-10 scale 30 minutes after postanesthesia care unit admission
QT prolongation on the EKG on the morning of postoperative day one

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: methadone groupActive Control1 Intervention
Patients in this group will receive a syringe of methadone at the induction of anesthesia and a syringe of saline at the end of anesthesia.
Group II: hydromorphone groupPlacebo Group1 Intervention
Patients in this group will receive a syringe of saline at induction of anesthesia and a syringe of hydromorphone at the end of anesthesia

Find a Location

Who is running the clinical trial?

NorthShore University HealthSystemLead Sponsor
132 Previous Clinical Trials
737,502 Total Patients Enrolled
Glenn S Murphy, MDPrincipal InvestigatorNorthShore University HealthSystem
8 Previous Clinical Trials
1,010 Total Patients Enrolled
~19 spots leftby Nov 2025