NCT06037330 Nalbuphine in ARDS Patients After Surgery
| NCT ID | NCT06037330 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Hairong Chen |
| Condition | Acute Respiratory Distress Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2026-04-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2023-09-01 with a primary completion date of 2026-04-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Critically ill patients need reasonable and moderate analgesic and sedative treatment to eliminate or reduce pain, anxiety and restlessness, improve patient comfort and cooperation, reduce patients' stress response, protect organ function and optimize prognosis. As a semi-synthetic opioid receptor agonist-antagonist, nalbuphine can bind to μ, κand δ receptors, has partial antagonistic effect on μ receptor, and is fully activated on κreceptor, with very weak δ receptor activity. Results of a study on the efficacy and safety of nalbuphine for analgesia in ICU patients showed that nalbuphine has sustained and stable analgesic effect for patients with mild to moderate analgesic needs in ICU, the onset time is comparable to sufentanil, and excessive sedation caused by sufentanil can be avoided, and the effect on hemodynamics is small. It can be used as a new choice of analgesic drugs in ICU. A single-center, randomized, single-blind, prospective study was designed to compare nalbuphine and sufentanil in patients with ARDS after surgery. Sixty patients with ARDS after surgery to be admitted to ICU were randomly divided into experimental group (Nalbuphine group) and control group (Sufentanil group). This study aims to determine the analgesic efficacy and safety of nalbuphine hydrochloride in patients with Acute Respiratory distress syndrome (ARDS) after surgery. The successful development of this study will provide more theoretical basis for the individualized analgesic sedation program for surgical patients.
Eligibility Criteria
Inclusion Criteria: * Had undergone surgical treatment within 7 days before enrollment; * Meet the diagnostic criteria for ARDS proposed at the 2011 Berlin ARDS Definition Conference; * Age ≥18 years old, gender unlimited; * Patients admitted to ICU with CPOT score ≥3; * Stay in ICU ≥48h; * Sign the informed consent form. Exclusion Criteria: * APACHE II score ≥23 points; * Patients with esophageal reflux disease and severe gastrointestinal injury have AGI score ≥3; * Long-term use of narcotic analgesics, hypnotics and psychotropic drugs; * Alcohol withdrawal symptoms; * Severe liver dysfunction (Child-Pugh grade C); * Patients with bronchial asthma and myasthenia gravis; * Patients with severe craniocerebral injury, brain tumor, and increased intracranial pressure are prone to respiratory depression; * Patients undergoing cardiac surgery under cardiopulmonary bypass; * Patients who have been enrolled in other clinical trials; * Study patients with drug allergy or other contraindications; * Pregnant or lactating women; * The patient himself or his legally authorized representative is unwilling to sign the informed consent;
Contact & Investigator
Hairong Chen, doctor
STUDY DIRECTOR
Qianfo Mountain Hospital, Shandong Province
Frequently Asked Questions
Who can join the NCT06037330 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Respiratory Distress Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06037330 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06037330 currently recruiting?
Yes, NCT06037330 is actively recruiting participants. Contact the research team at wangquanzhen1986@163.com for enrollment information.
Where is the NCT06037330 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT06037330 clinical trial?
NCT06037330 is sponsored by Hairong Chen. The principal investigator is Hairong Chen, doctor at Qianfo Mountain Hospital, Shandong Province. The trial plans to enroll 60 participants.