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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorEndeavor Health

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • methadone

    Drug

    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

    Drug

    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

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: methadone groupActive comparator 1 intervention
Group B: hydromorphone groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

QT prolongation on the EKG 30 minutes after postanesthesia care unit admission

EKGs will be obtained 30 minutes after postanesthesia care unit admission

Time frame
30 minutes after post anesthesia care unit admission

Secondary outcomes

1

QT prolongation on the EKG on the morning of postoperative day one

EKGs will be obtained on the morning of postoperative day one

Time frame
24 hours after surgery
2

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)

Time frame
30 minutes after postanesthesia care unit admission
3

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)

Time frame
24 hours after surgery

Other outcomes

Sponsors and contacts

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