<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/NCT03786887</url>
  </required_header>
  <id_info>
    <org_study_id>HShu</org_study_id>
    <nct_id>NCT03786887</nct_id>
  </id_info>
  <brief_title>The 90% Effective Dose of Nalbuphine in Mechanical Ventilated Patients in the ICU</brief_title>
  <official_title>The 90% Effective Dose of Nalbuphine in Mechanical Ventilated Patients in the ICU</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hua-Qing Shu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wuhan Union Hospital, China</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to determine the effective nalbuphine dose in 90% of intubated&#xD;
      patients in the ICU, including the continuous infusion dose and a bolus dose during moving to&#xD;
      the lateral decubitus position. Pain will assessed using a Behavioural Pain Scale (BPS)&#xD;
      requiring a score of 3-4.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The continuous nalbuphine infusion dose starts at 100ug/kg/h, if the BPS scores reaches 3-4,&#xD;
      the continuous infusion dose would be decreased by 20 ug/kg/h for next patients. If not,&#xD;
      increased by 20 ug/kg/h.&#xD;
&#xD;
      The nalbuphine bolus is injected 5 min before turning the patients and the dose (starting at&#xD;
      0) is increased by 0.05 mg/kg, prior to each subsequent turn to lateral decubitus until a BPS&#xD;
      score of 3-4 is obtained.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 24, 2018</start_date>
  <completion_date type="Anticipated">October 2019</completion_date>
  <primary_completion_date type="Anticipated">October 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Continuous pumping dose of nalbuphine</measure>
    <time_frame>2 days</time_frame>
    <description>The effective continuous infusion dose of nalbuphine to obtain a satisfactory analgesia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nalbuphine bolus dose</measure>
    <time_frame>3 days</time_frame>
    <description>The effective dose of a nalbuphine bolus to obtain a satisfactory analgesia</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Nalbuphine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nalbuphine</intervention_name>
    <description>dosage of nalbuphine</description>
    <arm_group_label>Nalbuphine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mechanical invasive ventilation&#xD;
&#xD;
          -  Sedated only with nalbuphine&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast-feeding woman&#xD;
&#xD;
          -  Age below 18 or over 80 years&#xD;
&#xD;
          -  An indication for deep sedation (e.g.the initial stage of septic shock, acute brain&#xD;
             injury or acute respiratory distress syndrome)&#xD;
&#xD;
          -  Renal dialysis&#xD;
&#xD;
          -  The inability to assess pain by the BPS scale (e.g. paralysis)&#xD;
&#xD;
          -  BMI less than 18 or more than 35&#xD;
&#xD;
          -  Preadmission use of opioid analgesic for chronic pain&#xD;
&#xD;
          -  Severe hepatic failure&#xD;
&#xD;
          -  State of consciousness with impossibility to use self-assessment scale; monoamine&#xD;
             oxidase inhibitors&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>You Shang</last_name>
    <phone>+8615972127819</phone>
    <email>shang_you@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Critical Care Medicine, Union Hospital, Wuhan</name>
      <address>
        <city>Wuhan</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>You Shang</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Chaveron D, Silva S, Sanchez-Verlaan P, Conil JM, Sommet A, Geeraerts T, Genestal M, Minville V, Fourcade O. The 90% effective dose of a sufentanil bolus for the management of painful positioning in intubated patients in the ICU. Eur J Anaesthesiol. 2012 Jun;29(6):280-5. doi: 10.1097/EJA.0b013e328352234d.</citation>
    <PMID>22388706</PMID>
  </reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 24, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>December 24, 2018</last_update_submitted>
  <last_update_submitted_qc>December 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Wuhan Union Hospital, China</investigator_affiliation>
    <investigator_full_name>Hua-Qing Shu</investigator_full_name>
    <investigator_title>Associate chief physician</investigator_title>
  </responsible_party>
  <keyword>mechanical ventilation</keyword>
  <keyword>nalbuphine</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>


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/NCT03786887
org study id: HShu
nct id: NCT03786887
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to determine the effective nalbuphine dose in 90% of intubated
      patients in the ICU, including the continuous infusion dose and a bolus dose during moving to
      the lateral decubitus position. Pain will assessed using a Behavioural Pain Scale (BPS)
      requiring a score of 3-4.
The continuous nalbuphine infusion dose starts at 100ug/kg/h, if the BPS scores reaches 3-4,
      the continuous infusion dose would be decreased by 20 ug/kg/h for next patients. If not,
      increased by 20 ug/kg/h.

      The nalbuphine bolus is injected 5 min before turning the patients and the dose (starting at
      0) is increased by 0.05 mg/kg, prior to each subsequent turn to lateral decubitus until a BPS
      score of 3-4 is obtained.
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Continuous pumping dose of nalbuphine
time frame: 2 days
description: The effective continuous infusion dose of nalbuphine to obtain a satisfactory analgesia
measure: Nalbuphine bolus dose
time frame: 3 days
description: The effective dose of a nalbuphine bolus to obtain a satisfactory analgesia
arm group label: Nalbuphine
arm group type: Experimental
intervention type: Drug
intervention name: Nalbuphine
description: dosage of nalbuphine
arm group label: Nalbuphine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: You Shang
phone: +8615972127819
email: shang_you@126.com
facility: 
status: Recruiting
contact: 
country: China
citation: Chaveron D, Silva S, Sanchez-Verlaan P, Conil JM, Sommet A, Geeraerts T, Genestal M, Minville V, Fourcade O. The 90% effective dose of a sufentanil bolus for the management of painful positioning in intubated patients in the ICU. Eur J Anaesthesiol. 2012 Jun;29(6):280-5. doi: 10.1097/EJA.0b013e328352234d.
PMID: 22388706
responsible party type: Sponsor-Investigator
investigator affiliation: Wuhan Union Hospital, China
investigator full name: Hua-Qing Shu
investigator title: Associate chief physician
mesh term: Nalbuphine
sharing ipd: No