Status:
RECRUITING
Nalbuphine in ARDS Patients After Surgery
Lead Sponsor:
Hairong Chen
Conditions:
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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' s...
Detailed Description
Severe patients need reasonable and moderate analgesic sedation to eliminate or reduce pain, anxiety and agitation, improve comfort and cooperation, reduce stress response, protect organ function and ...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06037330
Start Date
September 1 2023
End Date
November 30 2026
Last Update
March 13 2024
Active Locations (1)
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1
Department of Intensive Care Medicine
Jinan, Shandong, China, 250014