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Trial record 37 of 74 for:    "Andersen-Tawil syndrome" OR "Long QT Syndrome"

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

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ClinicalTrials.gov Identifier: NCT03893734
Recruitment Status : Recruiting
First Posted : March 28, 2019
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Glenn S. Murphy, MD, NorthShore University HealthSystem

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.

Condition or disease Intervention/treatment Phase
EKG-QT Prolongation Drug: methadone Drug: Hydromorphone Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized to receive either methadone at the start of anesthesia or hydromorphone at the end of surgery
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Clinicians will be provided with two blinded syringes containing either saline and hydromorphone or methadone and saline.
Primary Purpose: Diagnostic
Official Title: Effect of Methadone and Hydromorphone on the QT Interval After Anesthesia and Surgery
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : August 12, 2019
Estimated Study Completion Date : December 23, 2019


Arm Intervention/treatment
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.
Drug: 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

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
Drug: 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 Measures :
  1. QT prolongation on the EKG 30 minutes after postanesthesia care unit admission [ Time Frame: 30 minutes after post anesthesia care unit admission ]
    EKGs will be obtained 30 minutes after postanesthesia care unit admission


Secondary Outcome Measures :
  1. QT prolongation on the EKG on the morning of postoperative day one [ Time Frame: 24 hours after surgery ]
    EKGs will be obtained on the morning of postoperative day one

  2. Level of pain on on a 0-10 scale 30 minutes after postanesthesia care unit admission [ Time Frame: 30 minutes after postanesthesia care unit admission ]
    Pain will be assessed on a 0-10 scale (0=no pain, 10 worst pain imaginable)

  3. Level of pain on a 0-10 scale on the morning of postoperative day one [ Time Frame: 24 hours after surgery ]
    Pain will be assessed on a 0-10 scale (0=no pain, 10 worst pain imaginable)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03893734


Contacts
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Contact: Lucyna W Klatzco 264-364-7272 lklatzco@northshore.org

Locations
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United States, Illinois
NorthShore University HealthSystem Recruiting
Evanston, Illinois, United States, 60201
Contact: Glenn S Murphy, MD    847-570-2760    dgmurphy2@yahoo.com   
Contact: Joseph W Szokol, MD    847-570-2760    szokolmd@gmail.com   
Sponsors and Collaborators
NorthShore University HealthSystem
Investigators
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Principal Investigator: Glenn S Murphy, MD NorthShore University HealthSystem

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Responsible Party: Glenn S. Murphy, MD, Director of Clinical Research, NorthShore University HealthSystem
ClinicalTrials.gov Identifier: NCT03893734     History of Changes
Other Study ID Numbers: ENH-01745
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Long QT Syndrome
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Pathologic Processes
Anesthetics
Methadone
Hydromorphone
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents