Recruiting

Methadone & Hydromorphone

Sponsor:

Endeavor Health

Code:

NCT03893734

Conditions

EKG-QT Prolongation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

methadone

Hydromorphone

Study Details

Brief 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

EKG-QT Prolongation

Study ID

NCT03893734

Start date

May 1, 2018

Status verified date

Sep, 2019

Completion date

Dec 23, 2020

Anticipated

Primary completion date

Aug 12, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • All patients presenting for elective surgical cases requiring general anesthesia and associated with moderate-to-severe postoperative pain will be eligible for enrollment.

Exclusion Criteria:

  • History of arrhythmias, pacemaker, or defibrillator
  • Allergy to methadone or hydromorphone
  • Preoperative altered mental status
  • Abnormal serum electrolyte values
  • Existence of significant valvular disease or cardiac rhythm other than sinus
  • Significant preoperative pain requiring treatment with opioids or recent history of opioid abuse

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: methadone group

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.

placebo comparator: hydromorphone group

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

Interventions

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

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

Primary outcome measure

  • QT prolongation on the EKG 30 minutes after postanesthesia care unit admission [ Time Frame: 30 minutes after post anesthesia care unit admission ]

Central Contacts and Locations

Central contacts

Locations

NorthShore University HealthSystem

Recruiting

Evanston, Illinois, United States, 60201

Contacts

More Information

Sponsor

Endeavor Health

Last update posted

Sep 13, 2019

Last verified

Sep, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Endeavor Health on 2019-09-13.