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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 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. The trial reports 1 study location across 1 state.
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.
Conditions Studied
Interventions
- DRUG Hydromorphone
- DRUG methadone
Study Locations (1)
Illinois
- NorthShore University HealthSystem - Evanston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2018-05-01 |
| Est. Completion | 2020-12-23 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03893734
The ClinicalTrials.gov registry entry for NCT03893734 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endeavor Health, which has 94 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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