Intravenous Methadone in Perioperative Acute and Chronic Management in Chinese Adult Cardiac Surgical Patients
Active, not recruitingPhase 3NCT05913284
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Despite modern day improvements in pain treatment and availability of different analgesic modalities, suboptimal postoperative pain control remains an issue in cardiac surgical patients. Poorly controlled acute postoperative pain is associated with adverse physiological outcomes that impair the recovery of cardiac surgical patients. It is associated with decreased patient satisfaction, delayed postoperative ambulation, and the development of chronic postsurgical pain (CPSP). Intravenous opioids such as fentanyl and morphine have been the mainstay of perioperative analgesia for cardiac surgery, either by intermittent boluses by healthcare staff or through a patient-controlled device (PCA). The primary problem with this mechanism of delivery is that significant fluctuations in serum opioid concentrations can occur, resulting in effects which range from inadequate analgesia to overdose and respiratory depression. In contrast to intermittent administration of short-acting opioids such as morphine and fentanyl, a single dose administration of methadone can be considered.
Study details
- Official title
- Intravenous Methadone in Perioperative Acute and Chronic Management in Chinese Adult Cardiac Surgical Patients: a Pilot Randomized Controlled Trial
- Interventions
- Sponsor
- Chinese University of Hong Kong
- Start date
- 2024-01-15
- Primary completion
- 2026-02-01
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Hong Kong
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Aged 18 or older * Elective primary isolated coronary artery bypass grafting, aortic valve repair/replacement, mitral valve repair/replacement or combined coronary artery bypass/valve procedure via sternotomy * Expected extubation within 12 hours of surgery Exclusion Criteria: * emergency surgery * aortic surgery * redo surgery * preoperative renal failure requiring renal replacement therapy or creatinine clearance \<30ml/min (calculated by Cockcroft-Gault Formula * liver dysfunction (liver enzymes twice upper limit normal) * LVEF \< 40% at baseline * mechanical circulatory support in perioperative period * history of chronic pain or who regularly used pain medications (except paracetamol and non-steroidal anti-inflammatory drugs) * history of psychiatric illnesses or illicit drug use * intraoperative use of remifentanil * unable to provide informed consent
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05913284