<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/NCT04443946</url>
  </required_header>
  <id_info>
    <org_study_id>CINI-AD-20205-19</org_study_id>
    <nct_id>NCT04443946</nct_id>
  </id_info>
  <brief_title>Different Anesthesia Maintain Protocol Effect the Outcome of the Patients</brief_title>
  <official_title>Different Anesthesia Maintain Protocol Effect the Outcome of the Patients Undergoing General Anesthesia for Urinary Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China International Neuroscience Institution</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China International Neuroscience Institution</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This prospective open-label randomized study, patients were having elective urological&#xD;
      surgery scheduled to last longer than 1 h under necessitating general anesthesia.Group-P:&#xD;
      (Propofol group): 3 mg kg-1 min-1 propofol was pumped continuously after endotracheal&#xD;
      intubation. Group-PAS: (Propofol and after 20 min adding Sevoflurane group): 3 mg kg-1 min-1&#xD;
      propofol were pumped continuously and add 1% end-tidal sevoflurane 20 minutes after&#xD;
      endotracheal intubation. Group-PS: (Propofol and Sevoflurane group): 3 mg kg-1 min-1 propofol&#xD;
      were continuously pumped after endotracheal intubation, and 1% sevoflurane was inhaled&#xD;
      continuously at the same time. Group-S: (Sevoflurane group): 1% sevoflurane continued to&#xD;
      maintain anesthesia after endotracheal intubation. Group-PSu: (Propofol and Sufentanil&#xD;
      group): 3 mg kg-1 min-1 propofol, 0.01 μ g kg-1 min-1 sufentanil were pumped continuously at&#xD;
      maintain phase&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Group-P: (Propofol group): 3 mg kg-1 min-1 propofol was pumped continuously after&#xD;
      endotracheal intubation. Group-PAS: (Propofol and after 20 min adding Sevoflurane group): 3&#xD;
      mg kg-1 min-1 propofol were pumped continuously and add 1% end-tidal sevoflurane 20 minutes&#xD;
      after endotracheal intubation. Group-PS: (Propofol and Sevoflurane group): 3 mg kg-1 min-1&#xD;
      propofol were continuously pumped after endotracheal intubation, and 1% sevoflurane was&#xD;
      inhaled continuously at the same time. Group-S: (Sevoflurane group): 1% sevoflurane continued&#xD;
      to maintain anesthesia after endotracheal intubation. Group-PSu: (Propofol and Sufentanil&#xD;
      group): 3 mg kg-1 min-1 propofol, 0.01 μ g kg-1 min-1 sufentanil were pumped continuously at&#xD;
      maintain phase. Due to the ethical requirements of adequent analgesia, 0.3 μ g kg-1 min-1&#xD;
      remifentanil was continuously pumped as background input dose during anesthesia maintenance&#xD;
      in all groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 25, 2020</start_date>
  <completion_date type="Actual">August 5, 2020</completion_date>
  <primary_completion_date type="Actual">August 5, 2020</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Extubation Duration(ED)</measure>
    <time_frame>Up to 24 hours</time_frame>
    <description>the extubation Duration (ED) was calculated as the time from the end of anesthesia to extubation of the LMA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of PACU</measure>
    <time_frame>Up to 24 hours</time_frame>
    <description>Length of PACU (Post-anesthesia care unit): From entering the PACU to discharge from the PACU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>qNOX</measure>
    <time_frame>From entering the operation room until the discharge from the operation room, assessed up to 12 hours</time_frame>
    <description>Noceciption index,The qNOX of depth of analgesia also ranges from 99 to 0, and usually it is controlled to be within 40-60 during the operative period, with qNOX &gt; 80 indicating an insufficient use of analgesic agents and qNOX &lt; 10 indicating excessive analgesic effects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bis</measure>
    <time_frame>From entering the operation room until the discharge from the operation room, assessed up to 12 hours</time_frame>
    <description>Bispectral index,Bis 50-80 means appropriate Sedation depth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>From entering the operation room until the discharge from the operation room, assessed up to 12 hours</time_frame>
    <description>measuring Systolic, Diastolic and Mean Blood Pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The heart rate</measure>
    <time_frame>From entering the operation room until the discharge from the operation room, assessed up to 12 hours</time_frame>
    <description>The heart rate</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Urinary Surgery</condition>
  <condition>General Anesthesia</condition>
  <arm_group>
    <arm_group_label>Group-P</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group-P: (Propofol group): 5 mg kg-1 h-1 propofol was pumped continuously after endotracheal intubation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group-PAS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group-PAS: (Propofol and after 20 min adding Sevoflurane group): 2.5 mg kg-1 h-1 propofol were pumped continuously and add 1% end-tidal sevoflurane 20 minutes after endotracheal intubation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group-PS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group-PS: (Propofol and Sevoflurane group): 2.5 mg kg-1 h-1 propofol were continuously pumped after endotracheal intubation, and 1% sevoflurane was inhaled continuously at the same time.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group-S</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group-S: (Sevoflurane group): 2% sevoflurane continued to maintain anesthesia after endotracheal intubation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group-PSu</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group-PSu: (Propofol and Sufentanil group): 5 mg kg-1 h-1 propofol, 0.01 μ g kg-1 min-1 sufentanil were pumped continuously at maintain phase</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>5 mg kg-1 h-1 propofol was pumped continuously after endotracheal intubation.</description>
    <arm_group_label>Group-P</arm_group_label>
    <arm_group_label>Group-PSu</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1% Sevoflurane</intervention_name>
    <description>add 1% end-tidal sevoflurane 20 minutes after endotracheal intubation.</description>
    <arm_group_label>Group-PAS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1% Sevoflurane continue</intervention_name>
    <description>1% sevoflurane continued to maintain anesthesia after endotracheal intubation.</description>
    <arm_group_label>Group-PS</arm_group_label>
    <other_name>1% Sevoflurane</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sufentanil</intervention_name>
    <description>0.01 μ g kg-1 min-1 sufentanil were pumped continuously at maintain phase</description>
    <arm_group_label>Group-PSu</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>2% Sevoflurane</intervention_name>
    <description>2% sevoflurane continued to maintain anesthesia after endotracheal intubation.</description>
    <arm_group_label>Group-S</arm_group_label>
    <other_name>2% Sevoflurane continue</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol half</intervention_name>
    <description>2.5 mg kg-1 h-1 propofol was pumped continuously after endotracheal intubation.</description>
    <arm_group_label>Group-PAS</arm_group_label>
    <arm_group_label>Group-PS</arm_group_label>
    <other_name>2.5% Propofol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the aged 18-65 yr,&#xD;
&#xD;
          -  ASA physical status I, II or III patients&#xD;
&#xD;
          -  having elective urological surgery&#xD;
&#xD;
          -  operation scheduled to last longer than 1 h&#xD;
&#xD;
          -  under necessitating general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refused to participate in the study;&#xD;
&#xD;
          -  were not able to communicate due to alterations in the level of consciousness, - a&#xD;
             history of allergy to opioids&#xD;
&#xD;
          -  contraindications inhalational anaesthesia&#xD;
&#xD;
          -  family history of malignant hyperthermia&#xD;
&#xD;
          -  alcohol or drug abuse&#xD;
&#xD;
          -  received central nervous system-active drugs;&#xD;
&#xD;
          -  body mass index ≥40 kg/m2&#xD;
&#xD;
          -  represent conditions liable to alter the pharmacokinetic and pharmacodynamic behaviors&#xD;
             of the intravenous and inhalation anesthetics&#xD;
&#xD;
          -  previous head injury, neurologic or psychiatric disease&#xD;
&#xD;
          -  any disabling central nervous&#xD;
&#xD;
          -  cerebrovascular disease&#xD;
&#xD;
          -  current use of psychoactive or anti-convulsive medications&#xD;
&#xD;
          -  unstable angina&#xD;
&#xD;
          -  manifest congestive heart failure&#xD;
&#xD;
          -  airway management was expected to be difficult&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yanghai Cui</last_name>
    <role>Study Chair</role>
    <affiliation>China International Neuroscience Institution</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Xuanwu hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100053</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>October 10, 2020</last_update_submitted>
  <last_update_submitted_qc>October 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sufentanil</mesh_term>
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Sevoflurane</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04443946
org study id: CINI-AD-20205-19
nct id: NCT04443946
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This prospective open-label randomized study, patients were having elective urological
      surgery scheduled to last longer than 1 h under necessitating general anesthesia.Group-P:
      (Propofol group): 3 mg kg-1 min-1 propofol was pumped continuously after endotracheal
      intubation. Group-PAS: (Propofol and after 20 min adding Sevoflurane group): 3 mg kg-1 min-1
      propofol were pumped continuously and add 1% end-tidal sevoflurane 20 minutes after
      endotracheal intubation. Group-PS: (Propofol and Sevoflurane group): 3 mg kg-1 min-1 propofol
      were continuously pumped after endotracheal intubation, and 1% sevoflurane was inhaled
      continuously at the same time. Group-S: (Sevoflurane group): 1% sevoflurane continued to
      maintain anesthesia after endotracheal intubation. Group-PSu: (Propofol and Sufentanil
      group): 3 mg kg-1 min-1 propofol, 0.01 μ g kg-1 min-1 sufentanil were pumped continuously at
      maintain phase
Group-P: (Propofol group): 3 mg kg-1 min-1 propofol was pumped continuously after
      endotracheal intubation. Group-PAS: (Propofol and after 20 min adding Sevoflurane group): 3
      mg kg-1 min-1 propofol were pumped continuously and add 1% end-tidal sevoflurane 20 minutes
      after endotracheal intubation. Group-PS: (Propofol and Sevoflurane group): 3 mg kg-1 min-1
      propofol were continuously pumped after endotracheal intubation, and 1% sevoflurane was
      inhaled continuously at the same time. Group-S: (Sevoflurane group): 1% sevoflurane continued
      to maintain anesthesia after endotracheal intubation. Group-PSu: (Propofol and Sufentanil
      group): 3 mg kg-1 min-1 propofol, 0.01 μ g kg-1 min-1 sufentanil were pumped continuously at
      maintain phase. Due to the ethical requirements of adequent analgesia, 0.3 μ g kg-1 min-1
      remifentanil was continuously pumped as background input dose during anesthesia maintenance
      in all groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Extubation Duration(ED)
time frame: Up to 24 hours
description: the extubation Duration (ED) was calculated as the time from the end of anesthesia to extubation of the LMA
measure: Length of PACU
time frame: Up to 24 hours
description: Length of PACU (Post-anesthesia care unit): From entering the PACU to discharge from the PACU
measure: qNOX
time frame: From entering the operation room until the discharge from the operation room, assessed up to 12 hours
description: Noceciption index,The qNOX of depth of analgesia also ranges from 99 to 0, and usually it is controlled to be within 40-60 during the operative period, with qNOX > 80 indicating an insufficient use of analgesic agents and qNOX < 10 indicating excessive analgesic effects.
measure: Bis
time frame: From entering the operation room until the discharge from the operation room, assessed up to 12 hours
description: Bispectral index,Bis 50-80 means appropriate Sedation depth
measure: Blood pressure
time frame: From entering the operation room until the discharge from the operation room, assessed up to 12 hours
description: measuring Systolic, Diastolic and Mean Blood Pressure
measure: The heart rate
time frame: From entering the operation room until the discharge from the operation room, assessed up to 12 hours
description: The heart rate
arm group label: Group-P
arm group type: Active Comparator
description: Group-P: (Propofol group): 5 mg kg-1 h-1 propofol was pumped continuously after endotracheal intubation.
arm group label: Group-PAS
arm group type: Experimental
description: Group-PAS: (Propofol and after 20 min adding Sevoflurane group): 2.5 mg kg-1 h-1 propofol were pumped continuously and add 1% end-tidal sevoflurane 20 minutes after endotracheal intubation.
arm group label: Group-PS
arm group type: Experimental
description: Group-PS: (Propofol and Sevoflurane group): 2.5 mg kg-1 h-1 propofol were continuously pumped after endotracheal intubation, and 1% sevoflurane was inhaled continuously at the same time.
arm group label: Group-S
arm group type: Experimental
description: Group-S: (Sevoflurane group): 2% sevoflurane continued to maintain anesthesia after endotracheal intubation.
arm group label: Group-PSu
arm group type: Experimental
description: Group-PSu: (Propofol and Sufentanil group): 5 mg kg-1 h-1 propofol, 0.01 μ g kg-1 min-1 sufentanil were pumped continuously at maintain phase
intervention type: Drug
intervention name: Propofol
description: 5 mg kg-1 h-1 propofol was pumped continuously after endotracheal intubation.
arm group label: Group-P
arm group label: Group-PSu
intervention type: Drug
intervention name: 1% Sevoflurane
description: add 1% end-tidal sevoflurane 20 minutes after endotracheal intubation.
arm group label: Group-PAS
intervention type: Drug
intervention name: 1% Sevoflurane continue
description: 1% sevoflurane continued to maintain anesthesia after endotracheal intubation.
arm group label: Group-PS
other name: 1% Sevoflurane
intervention type: Drug
intervention name: Sufentanil
description: 0.01 μ g kg-1 min-1 sufentanil were pumped continuously at maintain phase
arm group label: Group-PSu
intervention type: Drug
intervention name: 2% Sevoflurane
description: 2% sevoflurane continued to maintain anesthesia after endotracheal intubation.
arm group label: Group-S
other name: 2% Sevoflurane continue
intervention type: Drug
intervention name: Propofol half
description: 2.5 mg kg-1 h-1 propofol was pumped continuously after endotracheal intubation.
arm group label: Group-PAS
arm group label: Group-PS
other name: 2.5% Propofol
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Yanghai Cui
role: Study Chair
affiliation: China International Neuroscience Institution
facility: 
country: China
responsible party type: Sponsor
mesh term: Sufentanil
mesh term: Propofol
mesh term: Sevoflurane