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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Department of Intensive Care Medicine
RECRUITING
Jinan
Contact Information
Primary
Quanzhen Wang, doctor
wangquanzhen1986@163.com
15562570205
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 60
Treatments
Experimental: Nalbuphine group
40 mg of nalbuphine was diluted into 50 mL solution, the load dose was 0.1mg/kg, the maintenance dose was 0.04-0.08mg/kg/h, the CPOT score was \<2, and the daily maximum dose was 160mg.
Active_comparator: Sufentanil group
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.
Sponsors
Leads: Hairong Chen

This content was sourced from clinicaltrials.gov