NCT06037330

Nalbuphine in ARDS Patients After Surgery

Analgesic Effect and Safety Analysis of Nalbuphine in ARDS Patients After Surgery

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hairong Chen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 improve 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. Nalbuphine exerts powerful analgesic and sedative effects at the spinal cord level, with rapid analgesic effect and long duration, almost no cardiovascular adverse reactions, mild respiratory depression and capping effect, low incidence of nausea, vomiting and skin pruritus, and low addiction. 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. Moreover, nalbuphine theoretically has no σ-receptor excitability, is not hallucinogenic, and the chance of inducing delirium is lower. Studies have shown that nalbuphine can reduce postoperative inflammation and oxidative stress and has a lung protective effect. This study aims to determine the analgesic efficacy and safety of nalbuphine hydrochloride in patients with Acute Respiratory distress syndrome (ARDS) after surgery, and to explore the effects of nalbuphine hydrochloride on respiratory function, gastrointestinal function and cognitive function. To provide more theoretical basis for individualized analgesic and sedation program for surgical patients. Sixty patients were included and randomly divided into 1:1 groups, with 30 patients in each group. All patients were included according to strict inclusion criteria. The experimental group was given nalbuphine analgesia and the control group was given sufentanil analgesia. The number of patients reaching the target level of analgesia and sedation at each time node, invasive mechanical ventilation time, oxygenation index change, mortality and other indicators were compared between the two groups.

Conditions

• Acute Respiratory Distress Syndrome

Interventions

Type	Name	Description
DRUG	Nalbuphine	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.
DRUG	Sufentanil	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

Timeline

• Start date: 2023-09-01
• Primary completion: 2026-04-28
• Completion: 2026-11-30
• First posted: 2023-09-14
• Last updated: 2024-03-13

Locations

1 site across 1 country: China