xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06037330</url>
    </required_header>
    <id_info>
      <org_study_id>QFSYXLL-KY-2022(092)</org_study_id>
      <nct_id>NCT06037330</nct_id>
    </id_info>
    <brief_title>Nalbuphine in ARDS Patients After Surgery</brief_title>
    <official_title>Analgesic Effect and Safety Analysis of Nalbuphine in ARDS Patients After Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hairong Chen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Qianfoshan Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Critically ill patients need reasonable and moderate analgesic and sedative treatment to&#xD;
        eliminate or reduce pain, anxiety and restlessness, improve patient comfort and cooperation,&#xD;
        reduce patients' stress response, protect organ function and optimize prognosis. As a&#xD;
        semi-synthetic opioid receptor agonist-antagonist, nalbuphine can bind to μ, κand δ&#xD;
        receptors, has partial antagonistic effect on μ receptor, and is fully activated on&#xD;
        κreceptor, with very weak δ receptor activity. Results of a study on the efficacy and safety&#xD;
        of nalbuphine for analgesia in ICU patients showed that nalbuphine has sustained and stable&#xD;
        analgesic effect for patients with mild to moderate analgesic needs in ICU, the onset time is&#xD;
        comparable to sufentanil, and excessive sedation caused by sufentanil can be avoided, and the&#xD;
        effect on hemodynamics is small. It can be used as a new choice of analgesic drugs in ICU.&#xD;
  &#xD;
        A single-center, randomized, single-blind, prospective study was designed to compare&#xD;
        nalbuphine and sufentanil in patients with ARDS after surgery. Sixty patients with ARDS after&#xD;
        surgery to be admitted to ICU were randomly divided into experimental group (Nalbuphine&#xD;
        group) and control group (Sufentanil group). This study aims to determine the analgesic&#xD;
        efficacy and safety of nalbuphine hydrochloride in patients with Acute Respiratory distress&#xD;
        syndrome (ARDS) after surgery. The successful development of this study will provide more&#xD;
        theoretical basis for the individualized analgesic sedation program for surgical patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Severe patients need reasonable and moderate analgesic sedation to eliminate or reduce pain,&#xD;
        anxiety and agitation, improve comfort and cooperation, reduce stress response, protect organ&#xD;
        function and improve prognosis. As a semi-synthetic opioid receptor agonist-antagonist,&#xD;
        nalbuphine can bind to μ, κand δ receptors, has partial antagonistic effect on μ receptor,&#xD;
        and is fully activated on κreceptor, with very weak δ receptor activity. Nalbuphine exerts&#xD;
        powerful analgesic and sedative effects at the spinal cord level, with rapid analgesic effect&#xD;
        and long duration, almost no cardiovascular adverse reactions, mild respiratory depression&#xD;
        and capping effect, low incidence of nausea, vomiting and skin pruritus, and low addiction.&#xD;
        Results of a study on the efficacy and safety of nalbuphine for analgesia in ICU patients&#xD;
        showed that nalbuphine has sustained and stable analgesic effect for patients with mild to&#xD;
        moderate analgesic needs in ICU, the onset time is comparable to sufentanil, and excessive&#xD;
        sedation caused by sufentanil can be avoided, and the effect on hemodynamics is small. It can&#xD;
        be used as a new choice of analgesic drugs in ICU. Moreover, nalbuphine theoretically has no&#xD;
        σ-receptor excitability, is not hallucinogenic, and the chance of inducing delirium is lower.&#xD;
        Studies have shown that nalbuphine can reduce postoperative inflammation and oxidative stress&#xD;
        and has a lung protective effect.&#xD;
  &#xD;
        This study aims to determine the analgesic efficacy and safety of nalbuphine hydrochloride in&#xD;
        patients with Acute Respiratory distress syndrome (ARDS) after surgery, and to explore the&#xD;
        effects of nalbuphine hydrochloride on respiratory function, gastrointestinal function and&#xD;
        cognitive function. To provide more theoretical basis for individualized analgesic and&#xD;
        sedation program for surgical patients. Sixty patients were included and randomly divided&#xD;
        into 1:1 groups, with 30 patients in each group. All patients were included according to&#xD;
        strict inclusion criteria.&#xD;
  &#xD;
        The experimental group was given nalbuphine analgesia and the control group was given&#xD;
        sufentanil analgesia. The number of patients reaching the target level of analgesia and&#xD;
        sedation at each time node, invasive mechanical ventilation time, oxygenation index change,&#xD;
        mortality and other indicators were compared between the two groups.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">April 28, 2026</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number 1 of patients who achieved the target level of analgesia and sedation</measure>
      <time_frame>30 minutes after the analgesic is administered</time_frame>
      <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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number 2 of patients who achieved the target level of analgesia and sedation</measure>
      <time_frame>60 minutes after the analgesic is administered</time_frame>
      <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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number 3 of patients who achieved the target level of analgesia and sedation</measure>
      <time_frame>4 hours after the analgesic is administered</time_frame>
      <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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number 4 of patients who achieved the target level of analgesia and sedation</measure>
      <time_frame>8 hours after the analgesic is administered</time_frame>
      <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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number 5 of patients who achieved the target level of analgesia and sedation</measure>
      <time_frame>12 hours after the analgesic is administered</time_frame>
      <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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number 6 of patients who achieved the target level of analgesia and sedation</measure>
      <time_frame>24 hours after the analgesic is administered</time_frame>
      <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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Comparison of invasive mechanical ventilation time</measure>
      <time_frame>The time from the start of the tracheal intubation to the withdrawal of the ventilator, assessed up to 28 days</time_frame>
      <description>Invasive mechanical ventilation time was compared between the two groups</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Acute Respiratory Distress Syndrome</condition>
    <arm_group>
      <arm_group_label>Nalbuphine group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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 &lt;2, and the daily maximum dose was 160mg.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sufentanil group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <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 &lt;2 points.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Nalbuphine</intervention_name>
      <description>Nalbuphine was injected intravenously. The target CPOT score was &lt;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 &lt;2, and the maximum daily dose was 160mg.</description>
      <arm_group_label>Nalbuphine group</arm_group_label>
      <other_name>Nalbuphine Hydrochloride Injection</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sufentanil</intervention_name>
      <description>Sufentanil was injected intravenously, and the target CPOT score was &lt;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 &lt;2 points</description>
      <arm_group_label>Sufentanil group</arm_group_label>
      <other_name>Sufentanil citrate Injection</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Had undergone surgical treatment within 7 days before enrollment;&#xD;
  &#xD;
            -  Meet the diagnostic criteria for ARDS proposed at the 2011 Berlin ARDS Definition&#xD;
               Conference;&#xD;
  &#xD;
            -  Age ≥18 years old, gender unlimited;&#xD;
  &#xD;
            -  Patients admitted to ICU with CPOT score ≥3;&#xD;
  &#xD;
            -  Stay in ICU ≥48h;&#xD;
  &#xD;
            -  Sign the informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  APACHE II score ≥23 points;&#xD;
  &#xD;
            -  Patients with esophageal reflux disease and severe gastrointestinal injury have AGI&#xD;
               score ≥3;&#xD;
  &#xD;
            -  Long-term use of narcotic analgesics, hypnotics and psychotropic drugs;&#xD;
  &#xD;
            -  Alcohol withdrawal symptoms;&#xD;
  &#xD;
            -  Severe liver dysfunction (Child-Pugh grade C);&#xD;
  &#xD;
            -  Patients with bronchial asthma and myasthenia gravis;&#xD;
  &#xD;
            -  Patients with severe craniocerebral injury, brain tumor, and increased intracranial&#xD;
               pressure are prone to respiratory depression;&#xD;
  &#xD;
            -  Patients undergoing cardiac surgery under cardiopulmonary bypass;&#xD;
  &#xD;
            -  Patients who have been enrolled in other clinical trials;&#xD;
  &#xD;
            -  Study patients with drug allergy or other contraindications;&#xD;
  &#xD;
            -  Pregnant or lactating women;&#xD;
  &#xD;
            -  The patient himself or his legally authorized representative is unwilling to sign the&#xD;
               informed consent;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hairong Chen, doctor</last_name>
      <role>Study Director</role>
      <affiliation>Qianfo Mountain Hospital, Shandong Province</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Quanzhen Wang, doctor</last_name>
      <phone>15562570205</phone>
      <email>wangquanzhen1986@163.com</email>
    </overall_contact>
    <reference>
      <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.</citation>
      <PMID>9316825</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Qianfoshan Hospital</investigator_affiliation>
      <investigator_full_name>Hairong Chen</investigator_full_name>
      <investigator_title>Doctor of Medicine（M.D.）</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Distress Syndrome</mesh_term>
      <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
      <mesh_term>Acute Lung Injury</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sufentanil</mesh_term>
      <mesh_term>Dsuvia</mesh_term>
      <mesh_term>Nalbuphine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06037330
  org study id: QFSYXLL-KY-2022(092)
  nct id: NCT06037330
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Number 1 of patients who achieved the target level of analgesia and sedation
  time frame: 30 minutes after the analgesic is administered
  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
  measure: Number 2 of patients who achieved the target level of analgesia and sedation
  time frame: 60 minutes after the analgesic is administered
  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
  measure: Number 3 of patients who achieved the target level of analgesia and sedation
  time frame: 4 hours after the analgesic is administered
  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
  measure: Number 4 of patients who achieved the target level of analgesia and sedation
  time frame: 8 hours after the analgesic is administered
  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
  measure: Number 5 of patients who achieved the target level of analgesia and sedation
  time frame: 12 hours after the analgesic is administered
  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
  measure: Number 6 of patients who achieved the target level of analgesia and sedation
  time frame: 24 hours after the analgesic is administered
  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
  measure: Comparison of invasive mechanical ventilation time
  time frame: The time from the start of the tracheal intubation to the withdrawal of the ventilator, assessed up to 28 days
  description: Invasive mechanical ventilation time was compared between the two groups
  arm group label: Nalbuphine group
  arm group type: Experimental
  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 group label: Sufentanil group
  arm group type: Active Comparator
  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: Nalbuphine
  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.
  arm group label: Nalbuphine group
  other name: Nalbuphine Hydrochloride Injection
  intervention type: Drug
  intervention name: Sufentanil
  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
  arm group label: Sufentanil group
  other name: Sufentanil citrate Injection
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Hairong Chen, doctor
  role: Study Director
  affiliation: Qianfo Mountain Hospital, Shandong Province
  last name: Quanzhen Wang, doctor
  phone: 15562570205
  email: wangquanzhen1986@163.com
  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.
  PMID: 9316825
  responsible party type: Sponsor-Investigator
  investigator affiliation: Qianfoshan Hospital
  investigator full name: Hairong Chen
  investigator title: Doctor of Medicine（M.D.）
  mesh term: Respiratory Distress Syndrome
  mesh term: Respiratory Distress Syndrome, Newborn
  mesh term: Acute Lung Injury
  mesh term: Sufentanil
  mesh term: Dsuvia
  mesh term: Nalbuphine
  sharing ipd: No