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NCT03893734 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of EKG-QT Prolongation, sponsored by Endeavor Health.

Recruiting
Registry status
Phase 4
Development phase
140
Enrollment target
1
Study location

NCT03893734: Recruiting Phase 4 study of EKG-QT Prolongation, sponsored by Endeavor Health.

NCT03893734 is a Phase 4 study of EKG-QT Prolongation that is actively recruiting participants, run by Endeavor Health. The registered enrollment target is 140 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03893734, a Phase 4 study of EKG-QT Prolongation, is actively recruiting participants, sponsored by Endeavor Health.

RECRUITING
Registry status
Phase 4
Development phase
140 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

EKGs will be obtained 30 minutes after postanesthesia care unit admission

Conditions Studied

Interventions

  • DRUG Hydromorphone
  • DRUG methadone

Study Locations (1)

Illinois

  • NorthShore University HealthSystem - Evanston

Trial Details

FieldValue
Enrollment Target 140 participants
Start Date 2018-05-01
Est. Completion 2020-12-23
Phase Phase 4
Endeavor Health

94 total trials

What NCT03893734 shows while recruiting

NCT03893734 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower).

The record links to 1 condition, with EKG-QT Prolongation appearing as the primary indexed condition, and to 2 interventions - of which Hydromorphone is the first listed.

NCT03893734 reports a single indexed study location in Illinois.

Frequently Asked Questions

What is clinical trial NCT03893734 about?

NCT03893734 is a clinical study titled "Effect of Methadone and Hydromorphone on the QT Interval After Anesthesia and Surgery". 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 undergoi...

What is the current status of trial NCT03893734?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 140 participants. The study started on 2018-05-01. Estimated completion is 2020-12-23.

What conditions does trial NCT03893734 study?

This clinical trial studies the following conditions: EKG-QT Prolongation.

What interventions are being tested in trial NCT03893734?

The interventions under investigation include: Hydromorphone (DRUG), methadone (DRUG).

Who is sponsoring clinical trial NCT03893734?

This trial is sponsored by Endeavor Health, which has 94 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03893734 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT03893734's enrollment target sits among peer trials

140 581st of 2000 higher than 1,409 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03893734, the US trial registry maintained by the National Library of Medicine. NCT03893734 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.