<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/NCT03760809</url>
  </required_header>
  <id_info>
    <org_study_id>dex-hyd</org_study_id>
    <nct_id>NCT03760809</nct_id>
  </id_info>
  <brief_title>Dexmedetomidine Combined With Hydromorphone in Tonsillectomy and Adenoidectomy</brief_title>
  <official_title>The Effect of Different Dose of Dexmedetomidine Combined With Hydromorphone in Children With Tonsillectomy and Adenoidectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eye &amp; ENT Hospital of Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eye &amp; ENT Hospital of Fudan 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>
      Tonsillectomy and adenoidectomy is one of the most common pediatric surgeries, and agitation&#xD;
      and severe postoperative pain have been considered a very common complications.&#xD;
      Dexmedetomidine mainly inhibits the release of norepinephrine by acting on the α-adrenergic&#xD;
      receptor of the brainstem nucleus, which can produce good sedative effects. Hydromorphone has&#xD;
      a longer duration of action than fentanyl, and it also has a certain sedative effect. The&#xD;
      combination of the two is more conducive to the management of postanesthetic agitation and&#xD;
      pain. This study was to compare the effect of different doses of dexmedetomidine combined&#xD;
      with hydromorphone in the sedation and analgesia after pediatric tonsillectomy and&#xD;
      adenoidectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The computer generates random numbers to allocate patients into different group. Trained&#xD;
      research staff who are not involved in the study collect the data. The observer who only&#xD;
      stayed in PACU was blinded to the allocation and responsible to record the data.&#xD;
&#xD;
      The primary measurement are pain scores, PAED scores, coughing was evaluated on a 9-point&#xD;
      scale (1= no coughing, 2= minimal coughing, one or two times, 3-4= moderate coughing, 3-4&#xD;
      times, 5-6= moderate coughing, more than 5 times, 7-8= severe coughing, more than 10 times,&#xD;
      9= laryngospasm), and extubation time. The secondary measurements are the time to discharge&#xD;
      from the post-anaesthesia care unit, and the number of postoperative desaturation.&#xD;
&#xD;
      A sample size of 57 was determined by analysis based on the assumption of the decline of&#xD;
      extubation time from other similar study and α=0.05,β=0.2.&#xD;
&#xD;
      The continuous variables were presented as means ± SD and the categorical variables were&#xD;
      expressed as frequency.&#xD;
&#xD;
      The outcome of interest is extubation time decline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 4, 2019</start_date>
  <completion_date type="Actual">April 1, 2019</completion_date>
  <primary_completion_date type="Actual">February 10, 2019</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>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>extubation time</measure>
    <time_frame>duration from the time that patients arrived in PACU to the time of extubation, though study completion, average 40 mins</time_frame>
    <description>the time of extubation after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Agitation scores</measure>
    <time_frame>scores at the time point of 0 minute after extubation</time_frame>
    <description>pediatric anesthesia emergence delirium (PAED) scores included five behaviors:(1)makes eye contact with caregiver,(2) actions are purposeful,(3) aware of surroundings,(4) restless,(5) inconsolable.&#xD;
Each behavior was correlated to different degree(4= not at all,3= just a little, 2= quite a bit, 1= very much,0= extremely). The scores for each of the five listed behaviors are added to achieve a total score (maximum score of 20, minimum score of 0). A score of &gt;12 is diagnosed to agitation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Agitation scores</measure>
    <time_frame>scores at the time point of 5 minutes after extubation</time_frame>
    <description>pediatric anesthesia emergence delirium (PAED) scores included five behaviors:(1)makes eye contact with caregiver,(2) actions are purposeful,(3) aware of surroundings,(4) restless,(5) inconsolable.&#xD;
Each behavior was correlated to different degree(4= not at all,3= just a little, 2= quite a bit, 1= very much,0= extremely). The scores for each of the five listed behaviors are added to achieve a total score (maximum score of 20, minimum score of 0). A score of &gt;12 is diagnosed to agitation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Agitation scores</measure>
    <time_frame>scores at the time point of 10 minutes after extubation</time_frame>
    <description>pediatric anesthesia emergence delirium (PAED) scores included five behaviors:(1)makes eye contact with caregiver,(2) actions are purposeful,(3) aware of surroundings,(4) restless,(5) inconsolable.&#xD;
Each behavior was correlated to different degree(4= not at all,3= just a little, 2= quite a bit, 1= very much,0= extremely). The scores for each of the five listed behaviors are added to achieve a total score (maximum score of 20, minimum score of 0). A score of &gt;12 is diagnosed to agitation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Agitation scores</measure>
    <time_frame>scores at the time point of 15 minutes after extubation</time_frame>
    <description>pediatric anesthesia emergence delirium (PAED) scores included five behaviors:(1)makes eye contact with caregiver,(2) actions are purposeful,(3) aware of surroundings,(4) restless,(5) inconsolable.&#xD;
Each behavior was correlated to different degree(4= not at all,3= just a little, 2= quite a bit, 1= very much,0= extremely). The scores for each of the five listed behaviors are added to achieve a total score (maximum score of 20, minimum score of 0). A score of &gt;12 is diagnosed to agitation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>coughing score</measure>
    <time_frame>scores at the time point of 0 minute after extubation</time_frame>
    <description>a 4-point scale that is used to measure severity of coughing(maximum score of 4, minimum score of 1):1= no coughing,2=minimal coughing, one or two times,3= moderate coughing,3-4 times,4= severe coughing, more than 5 times.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>coughing score</measure>
    <time_frame>scores at the time point of 5 minutes after extubation</time_frame>
    <description>a 9-point scale (1= no coughing, 2= minimal coughing, one or two times, 3-4= moderate coughing, 3-4 times, 5-6= moderate coughing, more than 5 times, 7-8= severe coughing, more than 10 times, 9= laryngospasm).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>coughing score</measure>
    <time_frame>scores at the time point of 10 minutes after extubation</time_frame>
    <description>a 9-point scale (1= no coughing, 2= minimal coughing, one or two times, 3-4= moderate coughing, 3-4 times, 5-6= moderate coughing, more than 5 times, 7-8= severe coughing, more than 10 times, 9= laryngospasm).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>coughing score</measure>
    <time_frame>scores at the time point of 15 minutes after extubation</time_frame>
    <description>a 9-point scale (1= no coughing, 2= minimal coughing, one or two times, 3-4= moderate coughing, 3-4 times, 5-6= moderate coughing, more than 5 times, 7-8= severe coughing, more than 10 times, 9= laryngospasm)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Agitated; State, Acute Reaction to Stress</condition>
  <arm_group>
    <arm_group_label>group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dexmedetomidine(0.5 μg／kg)/hydromophine-based general anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dexmedetomidine(1μg／kg)/hydromophine-based general anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine 0.5μg／kg</intervention_name>
    <description>Group A received dexmedetomidine 0.5μg／kg (diluted to 100ml，influded in 5 mins at the beginning of the surgery) and hydromophine 0.03 mg／kg as a bolus.</description>
    <arm_group_label>group A</arm_group_label>
    <other_name>Dexmedetomidine Hydrochloride Injection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine 1μg／kg</intervention_name>
    <description>Group B received dexmedetomidine 1μg／kg (diluted to 100ml，influded in 5 mins at the beginning of the surgery) and hydromophine 0.03 mg／kg as a bolus.</description>
    <arm_group_label>group B</arm_group_label>
    <other_name>Dexmedetomidine Hydrochloride Injection</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  experienced tonsillectomy and adenoidectomy&#xD;
&#xD;
          -  ASA physical status I-II&#xD;
&#xD;
          -  weight 12-30 kg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  respiratory disease&#xD;
&#xD;
          -  circulatory or nervous system disease&#xD;
&#xD;
          -  hepatic dysfunction&#xD;
&#xD;
          -  known adverse reactions to hydromophine and dexmedetomidine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>e ji Jia, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eye and ENT Hospital of Fudan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200031</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Olutoye OA, Glover CD, Diefenderfer JW, McGilberry M, Wyatt MM, Larrier DR, Friedman EM, Watcha MF. The effect of intraoperative dexmedetomidine on postoperative analgesia and sedation in pediatric patients undergoing tonsillectomy and adenoidectomy. Anesth Analg. 2010 Aug;111(2):490-5. doi: 10.1213/ANE.0b013e3181e33429. Epub 2010 Jul 7.</citation>
    <PMID>20610555</PMID>
  </reference>
  <results_reference>
    <citation>Brown KA. What we don't know about childhood obstructive sleep apnoea. Paediatr Anaesth. 2001 Jul;11(4):385-9. doi: 10.1046/j.1460-9592.2001.00719.x. No abstract available.</citation>
    <PMID>11442853</PMID>
  </results_reference>
  <results_reference>
    <citation>Patel A, Davidson M, Tran MC, Quraishi H, Schoenberg C, Sant M, Lin A, Sun X. Dexmedetomidine infusion for analgesia and prevention of emergence agitation in children with obstructive sleep apnea syndrome undergoing tonsillectomy and adenoidectomy. Anesth Analg. 2010 Oct;111(4):1004-10. doi: 10.1213/ANE.0b013e3181ee82fa. Epub 2010 Aug 12.</citation>
    <PMID>20705788</PMID>
  </results_reference>
  <results_reference>
    <citation>Hauber JA, Davis PJ, Bendel LP, Martyn SV, McCarthy DL, Evans MC, Cladis FP, Cunningham S, Lang RS, Campbell NF, Tuchman JB, Young MC. Dexmedetomidine as a Rapid Bolus for Treatment and Prophylactic Prevention of Emergence Agitation in Anesthetized Children. Anesth Analg. 2015 Nov;121(5):1308-15. doi: 10.1213/ANE.0000000000000931.</citation>
    <PMID>26332857</PMID>
  </results_reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>June 17, 2021</last_update_submitted>
  <last_update_submitted_qc>June 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dexmedetomidine</keyword>
  <keyword>hydromophine</keyword>
  <keyword>tonsillectomy and adenoidectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic, Acute</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</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/NCT03760809
org study id: dex-hyd
nct id: NCT03760809
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Tonsillectomy and adenoidectomy is one of the most common pediatric surgeries, and agitation
      and severe postoperative pain have been considered a very common complications.
      Dexmedetomidine mainly inhibits the release of norepinephrine by acting on the α-adrenergic
      receptor of the brainstem nucleus, which can produce good sedative effects. Hydromorphone has
      a longer duration of action than fentanyl, and it also has a certain sedative effect. The
      combination of the two is more conducive to the management of postanesthetic agitation and
      pain. This study was to compare the effect of different doses of dexmedetomidine combined
      with hydromorphone in the sedation and analgesia after pediatric tonsillectomy and
      adenoidectomy.
The computer generates random numbers to allocate patients into different group. Trained
      research staff who are not involved in the study collect the data. The observer who only
      stayed in PACU was blinded to the allocation and responsible to record the data.

      The primary measurement are pain scores, PAED scores, coughing was evaluated on a 9-point
      scale (1= no coughing, 2= minimal coughing, one or two times, 3-4= moderate coughing, 3-4
      times, 5-6= moderate coughing, more than 5 times, 7-8= severe coughing, more than 10 times,
      9= laryngospasm), and extubation time. The secondary measurements are the time to discharge
      from the post-anaesthesia care unit, and the number of postoperative desaturation.

      A sample size of 57 was determined by analysis based on the assumption of the decline of
      extubation time from other similar study and α=0.05,β=0.2.

      The continuous variables were presented as means ± SD and the categorical variables were
      expressed as frequency.

      The outcome of interest is extubation time decline.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: extubation time
time frame: duration from the time that patients arrived in PACU to the time of extubation, though study completion, average 40 mins
description: the time of extubation after surgery
measure: Agitation scores
time frame: scores at the time point of 0 minute after extubation
description: pediatric anesthesia emergence delirium (PAED) scores included five behaviors:(1)makes eye contact with caregiver,(2) actions are purposeful,(3) aware of surroundings,(4) restless,(5) inconsolable.
Each behavior was correlated to different degree(4= not at all,3= just a little, 2= quite a bit, 1= very much,0= extremely). The scores for each of the five listed behaviors are added to achieve a total score (maximum score of 20, minimum score of 0). A score of >12 is diagnosed to agitation.
measure: Agitation scores
time frame: scores at the time point of 5 minutes after extubation
description: pediatric anesthesia emergence delirium (PAED) scores included five behaviors:(1)makes eye contact with caregiver,(2) actions are purposeful,(3) aware of surroundings,(4) restless,(5) inconsolable.
Each behavior was correlated to different degree(4= not at all,3= just a little, 2= quite a bit, 1= very much,0= extremely). The scores for each of the five listed behaviors are added to achieve a total score (maximum score of 20, minimum score of 0). A score of >12 is diagnosed to agitation.
measure: Agitation scores
time frame: scores at the time point of 10 minutes after extubation
description: pediatric anesthesia emergence delirium (PAED) scores included five behaviors:(1)makes eye contact with caregiver,(2) actions are purposeful,(3) aware of surroundings,(4) restless,(5) inconsolable.
Each behavior was correlated to different degree(4= not at all,3= just a little, 2= quite a bit, 1= very much,0= extremely). The scores for each of the five listed behaviors are added to achieve a total score (maximum score of 20, minimum score of 0). A score of >12 is diagnosed to agitation.
measure: Agitation scores
time frame: scores at the time point of 15 minutes after extubation
description: pediatric anesthesia emergence delirium (PAED) scores included five behaviors:(1)makes eye contact with caregiver,(2) actions are purposeful,(3) aware of surroundings,(4) restless,(5) inconsolable.
Each behavior was correlated to different degree(4= not at all,3= just a little, 2= quite a bit, 1= very much,0= extremely). The scores for each of the five listed behaviors are added to achieve a total score (maximum score of 20, minimum score of 0). A score of >12 is diagnosed to agitation.
measure: coughing score
time frame: scores at the time point of 0 minute after extubation
description: a 4-point scale that is used to measure severity of coughing(maximum score of 4, minimum score of 1):1= no coughing,2=minimal coughing, one or two times,3= moderate coughing,3-4 times,4= severe coughing, more than 5 times.
measure: coughing score
time frame: scores at the time point of 5 minutes after extubation
description: a 9-point scale (1= no coughing, 2= minimal coughing, one or two times, 3-4= moderate coughing, 3-4 times, 5-6= moderate coughing, more than 5 times, 7-8= severe coughing, more than 10 times, 9= laryngospasm).
measure: coughing score
time frame: scores at the time point of 10 minutes after extubation
description: a 9-point scale (1= no coughing, 2= minimal coughing, one or two times, 3-4= moderate coughing, 3-4 times, 5-6= moderate coughing, more than 5 times, 7-8= severe coughing, more than 10 times, 9= laryngospasm).
measure: coughing score
time frame: scores at the time point of 15 minutes after extubation
description: a 9-point scale (1= no coughing, 2= minimal coughing, one or two times, 3-4= moderate coughing, 3-4 times, 5-6= moderate coughing, more than 5 times, 7-8= severe coughing, more than 10 times, 9= laryngospasm)
arm group label: group A
arm group type: Experimental
description: Dexmedetomidine(0.5 μg／kg)/hydromophine-based general anesthesia
arm group label: group B
arm group type: Experimental
description: Dexmedetomidine(1μg／kg)/hydromophine-based general anesthesia
intervention type: Drug
intervention name: Dexmedetomidine 0.5μg／kg
description: Group A received dexmedetomidine 0.5μg／kg (diluted to 100ml，influded in 5 mins at the beginning of the surgery) and hydromophine 0.03 mg／kg as a bolus.
arm group label: group A
other name: Dexmedetomidine Hydrochloride Injection
intervention type: Drug
intervention name: Dexmedetomidine 1μg／kg
description: Group B received dexmedetomidine 1μg／kg (diluted to 100ml，influded in 5 mins at the beginning of the surgery) and hydromophine 0.03 mg／kg as a bolus.
arm group label: group B
other name: Dexmedetomidine Hydrochloride Injection
criteria: 
gender: All
minimum age: 3 Years
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
last name: e ji Jia, M.D.
role: Principal Investigator
affiliation: Eye and ENT Hospital of Fudan University
facility: 
country: China
citation: Olutoye OA, Glover CD, Diefenderfer JW, McGilberry M, Wyatt MM, Larrier DR, Friedman EM, Watcha MF. The effect of intraoperative dexmedetomidine on postoperative analgesia and sedation in pediatric patients undergoing tonsillectomy and adenoidectomy. Anesth Analg. 2010 Aug;111(2):490-5. doi: 10.1213/ANE.0b013e3181e33429. Epub 2010 Jul 7.
PMID: 20610555
citation: Brown KA. What we don't know about childhood obstructive sleep apnoea. Paediatr Anaesth. 2001 Jul;11(4):385-9. doi: 10.1046/j.1460-9592.2001.00719.x. No abstract available.
PMID: 11442853
citation: Patel A, Davidson M, Tran MC, Quraishi H, Schoenberg C, Sant M, Lin A, Sun X. Dexmedetomidine infusion for analgesia and prevention of emergence agitation in children with obstructive sleep apnea syndrome undergoing tonsillectomy and adenoidectomy. Anesth Analg. 2010 Oct;111(4):1004-10. doi: 10.1213/ANE.0b013e3181ee82fa. Epub 2010 Aug 12.
PMID: 20705788
citation: Hauber JA, Davis PJ, Bendel LP, Martyn SV, McCarthy DL, Evans MC, Cladis FP, Cunningham S, Lang RS, Campbell NF, Tuchman JB, Young MC. Dexmedetomidine as a Rapid Bolus for Treatment and Prophylactic Prevention of Emergence Agitation in Anesthetized Children. Anesth Analg. 2015 Nov;121(5):1308-15. doi: 10.1213/ANE.0000000000000931.
PMID: 26332857
responsible party type: Sponsor
mesh term: Stress Disorders, Traumatic, Acute
mesh term: Dexmedetomidine
sharing ipd: No