About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
All patients presenting for elective surgical cases requiring general anesthesia and associated with moderate-to-severe postoperative pain will be eligible for enrollment.
Disqualifiers
History of arrhythmias, pacemaker, or defibrillator
Allergy to methadone or hydromorphone
Preoperative altered mental status
Abnormal serum electrolyte values
Trial design
Parallel
Treatments tested in this trial
methadone
DrugPatients 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
DrugPatients in the hydromorphone group will receive a syringe of saline at induction of anesthesia and a syringe of hydromorphone at the end of anesthesia
Treatment groups
Trial outcomes
Primary outcomes
QT prolongation on the EKG 30 minutes after postanesthesia care unit admission
EKGs will be obtained 30 minutes after postanesthesia care unit admission
Secondary outcomes
QT prolongation on the EKG on the morning of postoperative day one
EKGs will be obtained on the morning of postoperative day one
Level of pain on on a 0-10 scale 30 minutes after postanesthesia care unit admission
Pain will be assessed on a 0-10 scale (0=no pain, 10 worst pain imaginable)
Level of pain on a 0-10 scale on the morning of postoperative day one
Pain will be assessed on a 0-10 scale (0=no pain, 10 worst pain imaginable)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.