Oral Methadon in der Herzchirurgie (OMICS)
Orale Methadon-Anwendung in der Herzchirurgie
The purpose of this study is to compare the effects of administration of oral methadone preoperatively and intravenous methadone upon induction of general anesthesia on postoperative pain for patients undergoing elective cardiac surgery.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 4
Kontakte und Standorte
Studienorte
-
-
Minnesota
-
Rochester, Minnesota, Vereinigte Staaten, 55905
- Mayo Clinic in Rochester
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
• Undergoing elective cardiac surgery
Exclusion Criteria:
- Chronic pain requiring opioid medications as an outpatient
- Opioid use disorder on medication assistance treatment
- Prolonged QTc >500ms
- Chronic kidney disease with eGFR < 30mL/min
- Documented cirrhosis
- Intolerance to methadone
- Admitted inpatient in an intensive care unit (ICU) immediately prior to surgery
- Pregnancy at the time of surgery
- Subsequent surgeries after index surgery
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Intravenous methadone intraoperatively
Subjects in the IV methadone arm will receive methadone intravenously during cardiac surgery |
Patients will receive 0.3mg/kg methadone intravenously after induction of general anesthesia |
|
Experimental: Oral methadone, immediately prior to transport
Subjects in the oral methadone arm will receive methadone orally prior to cardiac surgery |
Patients will receive 0.4mg/kg PO methadone immediately prior to transport to the operating room |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Amount of opioid medication used 72 hours post-extubation
Zeitfenster: From hospital admission for surgery to 72 hours after the patient is extubated postoperatively
|
Opioid medication used at 72 hours post-extubation will be reported in morphine milligram equivalents |
From hospital admission for surgery to 72 hours after the patient is extubated postoperatively
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Amount of opioid medication used 24 hours post-extubation
Zeitfenster: From hospital admission for surgery to 24 hours after the patient is extubated postoperatively
|
Opioid medication used at 24 hours post-extubation will be reported in morphine milligram equivalents |
From hospital admission for surgery to 24 hours after the patient is extubated postoperatively
|
|
Amount of opioid medication used 48 hours post-extubation
Zeitfenster: From hospital admission for surgery to 48 hours after the patient is extubated postoperatively
|
Opioid medication used at 48 hours post-extubation will be reported in morphine milligram equivalents |
From hospital admission for surgery to 48 hours after the patient is extubated postoperatively
|
|
Amount of opioid medication required throughout hospitalization
Zeitfenster: From the time the patient is extubated until the time the patient leaves the hospital, approximately 10 days. Safety to leave the hospital is determined by the cardiac surgery team and can be several days after surgery or longer.
|
Opioid medication required from extubation until hospital discharge will be reported in morphine milligram equivalents |
From the time the patient is extubated until the time the patient leaves the hospital, approximately 10 days. Safety to leave the hospital is determined by the cardiac surgery team and can be several days after surgery or longer.
|
|
Amount of opioid medication required prior to extubation
Zeitfenster: From arrival in the ICU until extubation, approximately 6 hours. Safety of extubation is determined by the intensive care unit team and usually occurs within several hours of ICU arrival, although this can be variable.
|
Opioid medication required between the end of surgery and extubation will be documented in morphine milligram equivalents. |
From arrival in the ICU until extubation, approximately 6 hours. Safety of extubation is determined by the intensive care unit team and usually occurs within several hours of ICU arrival, although this can be variable.
|
|
Pain scores after extubation
Zeitfenster: 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours after extubation
|
Pain will be assessed by nursing staff using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable. |
6 hours, 12 hours, 24 hours, 48 hours, and 72 hours after extubation
|
|
Time to extubation
Zeitfenster: From the time the patient arrives in the ICU intubated until the time they are successfully extubated, approximately 12 hours. Safety of extubation is determined by the ICU team and usually occurs within several hours, although this can be variable.
|
This outcome will monitor the time in minutes from when a patient arrives in the ICU to the time the breathing tube is removed (extubation). |
From the time the patient arrives in the ICU intubated until the time they are successfully extubated, approximately 12 hours. Safety of extubation is determined by the ICU team and usually occurs within several hours, although this can be variable.
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Krishnan Ramanujan, M.D., Mayo Clinic
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 25-007292
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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