Actively Recruiting
Effect of Methadone and Hydromorphone on the QT Interval After Anesthesia and Surgery
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
Eligibility Criteria
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration of surgery and immediate postoperative period
Participants receive either a single dose of methadone or hydromorphone during anesthesia to assess effects on the QT interval.
1 visit during surgery and anesthesia, plus 1 visit 30 minutes after postanesthesia care unit admission
Duration - 1 day
Participants are monitored for QT prolongation and pain levels on the morning of postoperative day one.
1 visit approximately 24 hours after surgery
Trial Site Locations
Total: 1 location
1
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Actively Recruiting
Research Team
L
Lucyna W Klatzco
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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