Nalbuphine in ARDS Patients After Surgery
Analgesic Effect and Safety Analysis of Nalbuphine in ARDS Patients After Surgery
Hairong Chen
60 participants
Sep 1, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria12
- 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;
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Interventions
Nalbuphine was injected intravenously. The target CPOT score was \<2, and the target RASS score was -2 \~ 1. 40 mg of nalbuphine was diluted into 50 mL solution, the load was 0.1mg/kg, the maintenance dose was 0.04-0.08mg/kg/h, the CPOT score was \<2, and the maximum daily dose was 160mg.
Sufentanil was injected intravenously, and the target CPOT score was \<2, and the target RASS score was -2 \~ 1. 0.1mg of sufentanil was diluted into 50 mL solution, the loading dose was 0.2-0.5μg/kg, the maintenance dose was 0.2-0.3μg/kg/h, and the CPOT score was \<2 points
Locations(1)
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NCT06037330