Actively Recruiting

Phase 4
Age: 18Years - 80Years
All Genders
Healthy Volunteers
NCT03893734

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

Led by Endeavor Health · Updated on 2019-09-13

140

Participants Needed

1

Research Sites

138 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients presenting for elective surgery requiring general anesthesia
  • Surgery expected to cause moderate-to-severe postoperative pain
  • Age between 18 and 80 years
Not Eligible

You will not qualify if you...

  • History of arrhythmias, pacemaker, or defibrillator
  • Allergy to methadone or hydromorphone
  • Preoperative altered mental status
  • Abnormal serum electrolyte values
  • Significant valvular heart disease or non-sinus cardiac rhythm
  • Significant preoperative pain requiring opioids or recent opioid abuse

AI-Screening

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Trial Site Locations

Total: 1 location

1

NorthShore University HealthSystem

Evanston, Illinois, United States, 60201

Actively Recruiting

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Research Team

L

Lucyna W Klatzco

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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