Nalbuphine in ARDS Patients After Surgery
Recruiting now · Phase 4
Conditions studied: Acute Respiratory Distress Syndrome
In brief
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.
Key facts
- Study ID
- NCT06037330
- Run by
- Hairong Chen
- People needed
- 60
- Starts
- 2023-09-01
- Expected to finish
- 2026-11-30
- Last updated by the study team
- 2024-03-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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;
Where it is running
- Department of Intensive Care Medicine — Jinan, Shandong, China (enrolling)
Full record on ClinicalTrials.gov
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