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Intravenous Methadone in Perioperative Acute and Chronic Management in Chinese Adult Cardiac Surgical Patients

NCT05913284 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2025-03-27

No results posted yet for this study

Summary

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.

Conditions

  • Pain, Postoperative
  • Pain, Acute
  • Pain, Chronic
  • Anesthesia

Interventions

DRUG

Methadone

The drug will be prepared by study investigator and then handover to the anaesthesiologist which is blinded to the study. The syringe will be labelled as study drug and given on induction of anaesthesia as intravenous infusion over 30 minutes

DRUG

Morphine

The drug will be prepared by study investigator and then handover to the anaesthesiologist which is blinded to the study. The syringe will be labelled as study drug and given on induction of anaesthesia as intravenous infusion over 30 minutes

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Man Kin WONG, MBChB · Chinese Unversity of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2026-02-01
Completion
2026-04-01
FDA Drug
Yes

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05913284 on ClinicalTrials.gov