Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT03893734
PHASE4

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

Sponsor: Endeavor Health

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2018-05-01

Completion Date

2020-12-23

Last Updated

2019-09-13

Healthy Volunteers

Yes

Interventions

DRUG

methadone

Patients in the methadone group will receive a syringe of methadone at induction of anesthesia and a syringe of saline at the end of anesthesia

DRUG

Hydromorphone

Patients in the hydromorphone group will receive a syringe of saline at induction of anesthesia and a syringe of hydromorphone at the end of anesthesia

Locations (1)

NorthShore University HealthSystem

Evanston, Illinois, United States