Nalbuphine in ARDS Patients After Surgery

NCT06037330 | Recruiting Phase 4

• 1 other identifier: QFSYXLL-KY-2022(092)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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' 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

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (7)

• Number 1 of patients who achieved the target level of analgesia and sedation

  The number of patients in the two groups who reached the target level of analgesia and sedation within 30 minutes after the administration of analgesic drugs was compared

  30 minutes after the analgesic is administered

• Number 2 of patients who achieved the target level of analgesia and sedation

  The number of patients in the two groups who reached the target level of analgesia and sedation within 60 minutes after the administration of analgesic drugs was compared

  60 minutes after the analgesic is administered

• Number 3 of patients who achieved the target level of analgesia and sedation

  The number of patients in the two groups who reached the target level of analgesia and sedation within 4 hours after the administration of analgesic drugs was compared

  4 hours after the analgesic is administered

• Number 4 of patients who achieved the target level of analgesia and sedation

  The number of patients in the two groups who reached the target level of analgesia and sedation within 8 hours after the administration of analgesic drugs was compared

  8 hours after the analgesic is administered

• Number 5 of patients who achieved the target level of analgesia and sedation

  The number of patients in the two groups who reached the target level of analgesia and sedation within 12 hours after the administration of analgesic drugs was compared

  12 hours after the analgesic is administered

• Number 6 of patients who achieved the target level of analgesia and sedation

  The number of patients in the two groups who reached the target level of analgesia and sedation within 24 hours after the administration of analgesic drugs was compared

  24 hours after the analgesic is administered

• Comparison of invasive mechanical ventilation time

  Invasive mechanical ventilation time was compared between the two groups

  The time from the start of the tracheal intubation to the withdrawal of the ventilator, assessed up to 28 days

Study Arms (2)

Nalbuphine group

EXPERIMENTAL

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.

Drug: Nalbuphine

Sufentanil group

ACTIVE COMPARATOR

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.

Drug: Sufentanil

Interventions

Nalbuphine DRUG

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.

Also known as: Nalbuphine Hydrochloride Injection

Nalbuphine group

Sufentanil DRUG

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

Also known as: Sufentanil citrate Injection

Sufentanil group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hairong Chen: lead

Study Sites (1)

Department of Intensive Care Medicine

Jinan, Shandong, 250014, China

RECRUITING

Related Publications (1)

• Zacny JP, Conley K, Galinkin J. Comparing the subjective, psychomotor and physiological effects of intravenous buprenorphine and morphine in healthy volunteers. J Pharmacol Exp Ther. 1997 Sep;282(3):1187-97.

  PMID: 9316825 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Nalbuphine; Sufentanil

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Hairong Chen, doctor

  Qianfo Mountain Hospital, Shandong Province

  STUDY DIRECTOR

Central Study Contacts

Quanzhen Wang, doctor

CONTACT

15562570205; wangquanzhen1986@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor of Medicine（M.D.）

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: September 14, 2023
• Study Start: September 1, 2023
• Primary Completion: April 28, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)