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Phase 4
Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID03893734

Comparing Methadone and Hydromorphone Effects on Heart Rhythm After Surgery Under General Anesthesia

Led by Endeavor Health · Updated on 2019-09-13

140

Participants Needed

1

Research Sites

19 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the effects of methadone compared to hydromorphone on the QT interval of the electrocardiogram EKG in patients undergoing general anesthesia for surgery. The study focuses on understanding whether a single dose of intravenous methadone, given at anesthesia induction, causes significant QT prolongation, which can lead to a dangerous heart rhythm called torsade des pointes. This clinical trial is randomized and quadruple-blinded, aiming to clarify the cardiac safety of methadone use during surgery, as previous studies in chronic methadone users showed increased risk but the impact of a single dose during surgery remains unclear. Participants are randomly assigned to receive either methadone at induction of anesthesia followed by saline at the end, or saline at induction followed by hydromorphone at the end. Both drugs are opioids used for managing moderate-to-severe postoperative pain. The study measures the QT interval using a 12-lead EKG 30 minutes after admission to the postanesthesia care unit PACU and again on the morning after surgery postoperative day one. Secondary outcomes include pain levels and opioid-related complications. During the study, patients will have EKGs performed at specified time points to monitor QT prolongation. Pain levels will be assessed using a 0-10 scale both in the PACU and the following morning. Researchers will also observe for any sedation or respiratory complications related to opioid use. The total participation includes the surgery day and follow-up assessments on the first postoperative day. This trial aims to provide detailed safety and pain management data for methadone use in the perioperative setting.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 80 years
  • Patients undergoing elective surgery requiring general anesthesia
  • Surgery expected to cause moderate-to-severe postoperative pain
Not Eligible

You will not qualify if you...

  • History of arrhythmias, pacemaker, or defibrillator
  • Allergy to methadone or hydromorphone
  • Preoperative altered mental status
  • Abnormal serum electrolyte values
  • Significant valvular heart disease or non-sinus cardiac rhythm
  • Significant preoperative pain requiring opioids or recent opioid abuse

Research Team

L

Lucyna W Klatzco

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