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/NCT06009055</url>
    </required_header>
    <id_info>
      <org_study_id>hanyi20230117</org_study_id>
      <nct_id>NCT06009055</nct_id>
    </id_info>
    <brief_title>Effects of Remimazolam and Propofol on Anesthesia Induction</brief_title>
    <official_title>Effects of Remimazolam and Propofol on Heart Rate Variability in Type 2 Diabetes Patients During Anesthesia Induction</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zheng Guo</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Second Hospital of Shanxi Medical University</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 patients with diabetes who underwent laparoscopic cholecystectomy in the general surgery&#xD;
        department of the Second Hospital of Shanxi Medical University were selected. The patients&#xD;
        who were induced by remimazolam were included in the experimental group, and the patients who&#xD;
        were induced by propofol were included in the control group. All the selected patients had no&#xD;
        intimate relationship. The differences of blood pressure, heart rate and heart rate&#xD;
        variability (HRV) between the experimental group and the control group were observed.&#xD;
        According to the literature, it is speculated that the changes of blood pressure, heart rate&#xD;
        and HRV indexes in the experimental group are smaller than those in the control group, and&#xD;
        the difference is statistically significant.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 17, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2024</primary_completion_date>
    <phase>N/A</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>systolic pressure （SBP）</measure>
      <time_frame>24 hours</time_frame>
      <description>Changes in systolic blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>diastolic pressure（DBP）</measure>
      <time_frame>24 hours</time_frame>
      <description>change of diastolic blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>heart rate</measure>
      <time_frame>24 hours</time_frame>
      <description>change of heart rate</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Heart rate variability（HRV）</measure>
      <time_frame>24 hours</time_frame>
      <description>Changes of various indicators of heart rate variability</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Diabetes</condition>
    <arm_group>
      <arm_group_label>Remimazolam group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Propofol group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Remimazolam</intervention_name>
      <description>0.3mg/kg，injection completed in 30 seconds</description>
      <arm_group_label>Remimazolam group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Propofol</intervention_name>
      <description>2mg/kg，injection completed in 30 seconds</description>
      <arm_group_label>Propofol group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosed as type 2 diabetes according to the &quot;Chinese Guidelines for the Prevention&#xD;
               and Treatment of Type 2 diabetes 2020&quot;&#xD;
  &#xD;
            -  ASA II or III&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  People who are allergic to Remimazolam&#xD;
  &#xD;
            -  It is estimated that patients with difficulty in tracheal intubation (poor head and&#xD;
               neck mobility, history of airway surgery, history of OSAHS, nail to chin distance&lt;6cm,&#xD;
               Malampati grade 3 and above, mouth opening&lt;2.5cm, obesity (BMI&gt;30kg · m-2), etc&#xD;
  &#xD;
            -  Hypertension (clinically diagnosed as hypertension)&#xD;
  &#xD;
            -  Patients with coronary heart disease (with typical symptoms of angina pectoris and&#xD;
               exclusion of aortic valve disease, clear history of old myocardial infarction, clear&#xD;
               history of acute myocardial infarction, coronary stenosis greater than or equal to 70%&#xD;
               found by CAG)&#xD;
  &#xD;
            -  Patients with arrhythmia, heart failure, renal failure, and recently taking&#xD;
               cardiovascular active drugs&#xD;
  &#xD;
            -  Endocrine diseases such as hyperthyroidism and pheochromocytoma that may affect the&#xD;
               level of body hemodynamics&#xD;
  &#xD;
            -  Ketoacidosis and lactic acidosis&#xD;
  &#xD;
            -  Patients with long-term use of sedatives or antidepressants or a history of alcoholism&#xD;
               or drug dependence&#xD;
  &#xD;
            -  Asthma or reactive airway disease&#xD;
  &#xD;
            -  Patients with myasthenia gravis and cognitive dysfunction cannot cooperate with this&#xD;
               study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>econd of Shanxi Medical University</name>
        <address>
          <city>Taiyuan</city>
          <state>Shanxi</state>
          <zip>030001</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>zheng Guo</last_name>
        <phone>13753171979</phone>
        <email>13753171979@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>February 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Second Hospital of Shanxi Medical University</investigator_affiliation>
      <investigator_full_name>Zheng Guo</investigator_full_name>
      <investigator_title>professor</investigator_title>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Propofol</mesh_term>
    </intervention_browse>
    <!-- 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/NCT06009055
  org study id: hanyi20230117
  nct id: NCT06009055
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The patients with diabetes who underwent laparoscopic cholecystectomy in the general surgery
        department of the Second Hospital of Shanxi Medical University were selected. The patients
        who were induced by remimazolam were included in the experimental group, and the patients who
        were induced by propofol were included in the control group. All the selected patients had no
        intimate relationship. The differences of blood pressure, heart rate and heart rate
        variability (HRV) between the experimental group and the control group were observed.
        According to the literature, it is speculated that the changes of blood pressure, heart rate
        and HRV indexes in the experimental group are smaller than those in the control group, and
        the difference is statistically significant.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: systolic pressure （SBP）
  time frame: 24 hours
  description: Changes in systolic blood pressure
  measure: diastolic pressure（DBP）
  time frame: 24 hours
  description: change of diastolic blood pressure
  measure: heart rate
  time frame: 24 hours
  description: change of heart rate
  measure: Heart rate variability（HRV）
  time frame: 24 hours
  description: Changes of various indicators of heart rate variability
  arm group label: Remimazolam group
  arm group type: Experimental
  arm group label: Propofol group
  arm group type: Active Comparator
  intervention type: Drug
  intervention name: Remimazolam
  description: 0.3mg/kg，injection completed in 30 seconds
  arm group label: Remimazolam group
  intervention type: Drug
  intervention name: Propofol
  description: 2mg/kg，injection completed in 30 seconds
  arm group label: Propofol group
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 70 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Second Hospital of Shanxi Medical University
  investigator full name: Zheng Guo
  investigator title: professor
  mesh term: Propofol