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Nalbuphine in ARDS Patients After Surgery

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Nalbuphine
Sufentanil
Sponsored by
Hairong Chen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Nalbuphine group

    Sufentanil group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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
    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
    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
    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
    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
    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
    Comparison of invasive mechanical ventilation time
    Invasive mechanical ventilation time was compared between the two groups

    Secondary Outcome Measures

    Full Information

    First Posted
    August 17, 2023
    Last Updated
    September 7, 2023
    Sponsor
    Hairong Chen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06037330
    Brief Title
    Nalbuphine in ARDS Patients After Surgery
    Official Title
    Analgesic Effect and Safety Analysis of Nalbuphine in ARDS Patients After Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    April 28, 2026 (Anticipated)
    Study Completion Date
    November 30, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Hairong Chen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Respiratory Distress Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Nalbuphine group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Sufentanil group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Nalbuphine
    Other Intervention Name(s)
    Nalbuphine Hydrochloride Injection
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Sufentanil
    Other Intervention Name(s)
    Sufentanil citrate Injection
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Number 1 of patients who achieved the target level of analgesia and sedation
    Description
    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
    Time Frame
    30 minutes after the analgesic is administered
    Title
    Number 2 of patients who achieved the target level of analgesia and sedation
    Description
    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
    Time Frame
    60 minutes after the analgesic is administered
    Title
    Number 3 of patients who achieved the target level of analgesia and sedation
    Description
    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
    Time Frame
    4 hours after the analgesic is administered
    Title
    Number 4 of patients who achieved the target level of analgesia and sedation
    Description
    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
    Time Frame
    8 hours after the analgesic is administered
    Title
    Number 5 of patients who achieved the target level of analgesia and sedation
    Description
    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
    Time Frame
    12 hours after the analgesic is administered
    Title
    Number 6 of patients who achieved the target level of analgesia and sedation
    Description
    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
    Time Frame
    24 hours after the analgesic is administered
    Title
    Comparison of invasive mechanical ventilation time
    Description
    Invasive mechanical ventilation time was compared between the two groups
    Time Frame
    The time from the start of the tracheal intubation to the withdrawal of the ventilator, assessed up to 28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Criteria: 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;
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Quanzhen Wang, doctor
    Phone
    15562570205
    Email
    wangquanzhen1986@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hairong Chen, doctor
    Organizational Affiliation
    Qianfo Mountain Hospital, Shandong Province
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    9316825
    Citation
    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.
    Results Reference
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    Nalbuphine in ARDS Patients After Surgery

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