Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06037330

Nalbuphine in ARDS Patients After Surgery

Led by Hairong Chen · Updated on 2024-03-13

60

Participants Needed

1

Research Sites

169 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Nalbuphine in ARDS Patients After Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Had undergone surgical treatment within 7 days before enrollment
  • Diagnosed with ARDS according to the 2011 Berlin ARDS Definition Conference criteria
  • Age 18 years or older, any gender
  • Admitted to ICU with a CPOT score of 3 or higher
  • Planned ICU stay of at least 48 hours
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • APACHE II score of 23 points or higher
  • Esophageal reflux disease or severe gastrointestinal injury with AGI score of 3 or higher
  • Long-term use of narcotic analgesics, hypnotics, or psychotropic drugs
  • Experiencing alcohol withdrawal symptoms
  • Severe liver dysfunction (Child-Pugh grade C)
  • Bronchial asthma or myasthenia gravis
  • Severe brain injury, brain tumor, or increased intracranial pressure causing risk of respiratory depression
  • Undergoing cardiac surgery with cardiopulmonary bypass
  • Participating in other clinical trials
  • Drug allergy or other contraindications to study drugs
  • Pregnant or breastfeeding women
  • Unwilling or unable to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Department of Intensive Care Medicine

Jinan, Shandong, China, 250014

Actively Recruiting

Loading map...

Research Team

Q

Quanzhen Wang, doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here