<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/NCT04483427</url>
  </required_header>
  <id_info>
    <org_study_id>1984</org_study_id>
    <nct_id>NCT04483427</nct_id>
  </id_info>
  <brief_title>Multimodal Postoperative Analgesia Following OSA Surgery</brief_title>
  <official_title>Multimodal Postoperative Analgesia Using Accufuser for Multilevel Surgery for Obstructive Sleep Apnea (OSA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bahaa Mohammed Refaie</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sohag University</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>
      Assessment of the clinical efficacy and adverse effects of multimodal analgesic regimen&#xD;
      consisting of nalbuphine combined with ketorolac using IV continuous infusion silicon device&#xD;
      (Accufuser) for postoperative analgesia following multilevel OSA surgeries&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 20, 2020</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">July 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>Assessment will be carried out at zero time (time to shift to PACU) .</time_frame>
    <description>visual analog pain score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>Assessment will be carried out 6 hours postoperatively</time_frame>
    <description>Visual analog pain score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>Assessment will be carried out 12 hours postoperatively</time_frame>
    <description>Visual analog pain score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>Assessment will be carried out 18 hours postoperatively</time_frame>
    <description>Visual analog pain score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>Assessment will be carried out 24 hours postoperatively</time_frame>
    <description>Visual analog pain score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>Assessment will be carried out 30 hours postoperatively</time_frame>
    <description>Visual analog pain score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>Assessment will be carried out 36 hours postoperatively</time_frame>
    <description>Visual analog pain score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>Assessment will be carried out 42 hours postoperatively</time_frame>
    <description>Visual analog pain score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>Assessment will be carried out 48 hours postoperatively</time_frame>
    <description>Visual analog pain score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sedation level</measure>
    <time_frame>Zero time ( time to shift to PACU)</time_frame>
    <description>Ramsey sedation scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedation level</measure>
    <time_frame>6 hours postoperatively</time_frame>
    <description>Ramsey sedation scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedation level</measure>
    <time_frame>12 hours postoperatively</time_frame>
    <description>Ramsey Sedation Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedation level</measure>
    <time_frame>18 hours postoperatively</time_frame>
    <description>Ramsey Sedation Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedation level</measure>
    <time_frame>24 hours postoperatively</time_frame>
    <description>Ramsey Sedation Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedation level</measure>
    <time_frame>30 hours postoperatively</time_frame>
    <description>Ramsey Sedation scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedation level</measure>
    <time_frame>36 hours postoperatively</time_frame>
    <description>Ramsey Sedation Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedation level</measure>
    <time_frame>42 hours postoperatively</time_frame>
    <description>Ramsey Sedation Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedation level</measure>
    <time_frame>48 hours postoperatively</time_frame>
    <description>Ramsey Sedation Ramsey Sedation Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of adverse effects</measure>
    <time_frame>Zero time ( time to shift to PACU)</time_frame>
    <description>hypoxia, nausea, vomiting, itching</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of adverse effects</measure>
    <time_frame>6 hours postoperatively</time_frame>
    <description>hypoxia, nausea, vomiting, itching</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of adverse effects</measure>
    <time_frame>12 hours postoperatively</time_frame>
    <description>hypoxia, nausea, vomiting, itching</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of adverse effects</measure>
    <time_frame>18 hours postoperatively</time_frame>
    <description>hypoxia, nausea, vomiting, itching</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of adverse effects</measure>
    <time_frame>24 hours postoperatively</time_frame>
    <description>hypoxia, nausea, vomiting, itching</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of adverse effects</measure>
    <time_frame>30 hours postoperatively</time_frame>
    <description>hypoxia, nausea, vomiting, itching</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of adverse effects</measure>
    <time_frame>36 hours postoperatively</time_frame>
    <description>hypoxia, nausea, vomiting, itching</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of adverse effects</measure>
    <time_frame>42 hours postoperatively</time_frame>
    <description>hypoxia, nausea, vomiting, itching</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of adverse effects</measure>
    <time_frame>48 hours postoperatively</time_frame>
    <description>hypoxia, nausea, vomiting, itching</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>OSA patients after multilevel surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Nalbuphine, ketorolac, accufuser</intervention_name>
    <description>multimodal analgesic regimen consisting of nalbuphine combined with ketorolac using IV continuous infusion silicon device (Accufuser)</description>
    <arm_group_label>OSA patients after multilevel surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  physical status of American Society of Anesthesiologists (ASA) II&#xD;
&#xD;
          -  age between 30 - 50 years&#xD;
&#xD;
          -  OSA patients diagnosed by polysomnography and stop-bang questionnaire&#xD;
&#xD;
          -  enrolled for multilevel OSA surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of allergy to the study drugs&#xD;
&#xD;
          -  history of hepatic, cardiopulmonary or renal disease&#xD;
&#xD;
          -  history of any chronic pain on medication&#xD;
&#xD;
          -  history of substance abuse&#xD;
&#xD;
          -  psychiatric disorder&#xD;
&#xD;
          -  lack of patient cooperation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bahaa M Refaie, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lecturer of anesthesia and ICU sohag university</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohammed E Ahmed, MD</last_name>
    <role>Study Director</role>
    <affiliation>Lecturer of ENT sohag university</affiliation>
  </overall_official>
  <overall_official>
    <last_name>A M Elhalwagy, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Consultant of pain medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bahaa M Refaie, MD</last_name>
    <phone>0201026887257</phone>
    <email>bahaarefaay@med.sohag.edu.eg</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sohag faculty of medicine</name>
      <address>
        <city>Sohag</city>
        <zip>82524</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bahaa M Refaie, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>September 26, 2021</last_update_submitted>
  <last_update_submitted_qc>September 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Sohag University</investigator_affiliation>
    <investigator_full_name>Bahaa Mohammed Refaie</investigator_full_name>
    <investigator_title>Lecturer of anesthesia and ICU</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketorolac</mesh_term>
    <mesh_term>Nalbuphine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04483427
org study id: 1984
nct id: NCT04483427
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Assessment of the clinical efficacy and adverse effects of multimodal analgesic regimen
      consisting of nalbuphine combined with ketorolac using IV continuous infusion silicon device
      (Accufuser) for postoperative analgesia following multilevel OSA surgeries
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Postoperative pain
time frame: Assessment will be carried out at zero time (time to shift to PACU) .
description: visual analog pain score
measure: Postoperative pain
time frame: Assessment will be carried out 6 hours postoperatively
description: Visual analog pain score
measure: Postoperative pain
time frame: Assessment will be carried out 12 hours postoperatively
description: Visual analog pain score
measure: Postoperative pain
time frame: Assessment will be carried out 18 hours postoperatively
description: Visual analog pain score
measure: Postoperative pain
time frame: Assessment will be carried out 24 hours postoperatively
description: Visual analog pain score
measure: Postoperative pain
time frame: Assessment will be carried out 30 hours postoperatively
description: Visual analog pain score
measure: Postoperative pain
time frame: Assessment will be carried out 36 hours postoperatively
description: Visual analog pain score
measure: Postoperative pain
time frame: Assessment will be carried out 42 hours postoperatively
description: Visual analog pain score
measure: Postoperative pain
time frame: Assessment will be carried out 48 hours postoperatively
description: Visual analog pain score
measure: Sedation level
time frame: Zero time ( time to shift to PACU)
description: Ramsey sedation scale
measure: Sedation level
time frame: 6 hours postoperatively
description: Ramsey sedation scale
measure: Sedation level
time frame: 12 hours postoperatively
description: Ramsey Sedation Scale
measure: Sedation level
time frame: 18 hours postoperatively
description: Ramsey Sedation Scale
measure: Sedation level
time frame: 24 hours postoperatively
description: Ramsey Sedation Scale
measure: Sedation level
time frame: 30 hours postoperatively
description: Ramsey Sedation scale
measure: Sedation level
time frame: 36 hours postoperatively
description: Ramsey Sedation Scale
measure: Sedation level
time frame: 42 hours postoperatively
description: Ramsey Sedation Scale
measure: Sedation level
time frame: 48 hours postoperatively
description: Ramsey Sedation Ramsey Sedation Scale
measure: incidence of adverse effects
time frame: Zero time ( time to shift to PACU)
description: hypoxia, nausea, vomiting, itching
measure: incidence of adverse effects
time frame: 6 hours postoperatively
description: hypoxia, nausea, vomiting, itching
measure: incidence of adverse effects
time frame: 12 hours postoperatively
description: hypoxia, nausea, vomiting, itching
measure: incidence of adverse effects
time frame: 18 hours postoperatively
description: hypoxia, nausea, vomiting, itching
measure: incidence of adverse effects
time frame: 24 hours postoperatively
description: hypoxia, nausea, vomiting, itching
measure: incidence of adverse effects
time frame: 30 hours postoperatively
description: hypoxia, nausea, vomiting, itching
measure: incidence of adverse effects
time frame: 36 hours postoperatively
description: hypoxia, nausea, vomiting, itching
measure: incidence of adverse effects
time frame: 42 hours postoperatively
description: hypoxia, nausea, vomiting, itching
measure: incidence of adverse effects
time frame: 48 hours postoperatively
description: hypoxia, nausea, vomiting, itching
arm group label: OSA patients after multilevel surgery
arm group type: Experimental
intervention type: Combination Product
intervention name: Nalbuphine, ketorolac, accufuser
description: multimodal analgesic regimen consisting of nalbuphine combined with ketorolac using IV continuous infusion silicon device (Accufuser)
arm group label: OSA patients after multilevel surgery
criteria: 
gender: All
minimum age: 30 Years
maximum age: 50 Years
healthy volunteers: No
last name: Bahaa M Refaie, MD
role: Principal Investigator
affiliation: Lecturer of anesthesia and ICU sohag university
last name: Mohammed E Ahmed, MD
role: Study Director
affiliation: Lecturer of ENT sohag university
last name: A M Elhalwagy, MD
role: Study Chair
affiliation: Consultant of pain medicine
last name: Bahaa M Refaie, MD
phone: 0201026887257
email: bahaarefaay@med.sohag.edu.eg
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Sohag University
investigator full name: Bahaa Mohammed Refaie
investigator title: Lecturer of anesthesia and ICU
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Ketorolac
mesh term: Nalbuphine
sharing ipd: Undecided