<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/NCT04439786</url>
  </required_header>
  <id_info>
    <org_study_id>2020SDU-QILU-021</org_study_id>
    <nct_id>NCT04439786</nct_id>
  </id_info>
  <brief_title>Intravenous Infusion of Lidocaine in Colonoscopy</brief_title>
  <official_title>Efficacy of Intravenous Infusion of Lidocaine in Sedation for Colonoscopy: a Randomised Placebo-controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shandong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shandong University</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>
      intravenous infusion of lidocaine significantly reduce fatigue and pain and improve the&#xD;
      patients satisfaction after sedation for colonoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study divide patients into two groups, lidocaine group one will be given lidocaine&#xD;
      intravenously; control group will be given saline . the difference between patients fatigue&#xD;
      and pain will be compared. and the propofol consumption, pain after infusion of propofol,&#xD;
      patients, endoscopists and anaesthesist satifaction, the incidence of hypotenstion, hypoxia,&#xD;
      and bradycardia will aslo be compared between the two groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 1, 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>
    <intervention_model_description>Participants are randomly assigned to controll group or lidocaine group. Participants of control group are given placebo while participants of lidocaine group are given lidocaine.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>fatigue score after colonoscopy</measure>
    <time_frame>half a year</time_frame>
    <description>fatigue were measured on a 0-10VAS at arrival in the recovery room ,30min later</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pain socre after colonoscopy</measure>
    <time_frame>half a year</time_frame>
    <description>pain were measured on a 0-10VAS at arrival in the recovery room ,30min later</description>
  </secondary_outcome>
  <other_outcome>
    <measure>infusion pain when adminstrate propofol</measure>
    <time_frame>half a year</time_frame>
    <description>infusion pain was divided into no pain, mide pain and severe pain</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety assessed by the rate of hypoxia during the procedure Safety assessed by the rate of hypoxia during the procedure</measure>
    <time_frame>half a year</time_frame>
    <description>Hypoxia, defined as peripheral oxygen saturation &lt;90% for &gt;10 seconds</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety assessed by the rate of hypotention during the procedure</measure>
    <time_frame>half a year</time_frame>
    <description>Hypotension, defined as systolic blood pressure &lt;90 mmHg</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety assessed by the rate of breadycardia during the procedure</measure>
    <time_frame>half a year</time_frame>
    <description>Bradycardia, defined as heart rate &lt;50 beats/min</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety assessed by the rate of required airway management during the procedure</measure>
    <time_frame>half a year</time_frame>
    <description>Required airway management such as jaw lifting, mask ventilation, or tracheal intubation in severe hypoxia Required airway management such as jaw lifting, mask ventilation, or tracheal intubation in severe hypoxia</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety assessed by the rate of involuntary movement</measure>
    <time_frame>half a year</time_frame>
    <description>Involuntary movements, defined as unconscious movements requiring restraint or severe limb movement</description>
  </other_outcome>
  <other_outcome>
    <measure>endoscopists satisfaction assessed by the performer</measure>
    <time_frame>half a year</time_frame>
    <description>the endoscopists satisfacition score were assessed on a 0-10VAS after the procedure</description>
  </other_outcome>
  <other_outcome>
    <measure>patient satisfaction assessed by the patient</measure>
    <time_frame>half a year</time_frame>
    <description>the patient satisfacition score were assessed on a 0-10VAS 30mins after the procedure</description>
  </other_outcome>
  <other_outcome>
    <measure>anesthetist satisfaction assessed by the anesthestist</measure>
    <time_frame>half a year</time_frame>
    <description>the anesthetist satisfacition score were assessed on a 0-10VAS after the procedure</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Sedation</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>the control group will be given the same volume of saline as the experimental group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>lidocaine group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the experimental group will be given l-1.5mg lidocaine and then 2mg/kg/h</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>the control group will be given the same volume of saline.</description>
    <arm_group_label>control group</arm_group_label>
    <other_name>saline</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>lidocaine</intervention_name>
    <description>the experimental group will be given 1-1.5mg/kg lidocaine and then 2mg/kg/h</description>
    <arm_group_label>lidocaine group</arm_group_label>
    <other_name>Compound Lidocaine Hydrochloride Injiection</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion Criteria: patients aged &gt;18 years who were scheduled for colonscopy at Qilu&#xD;
        hospital.&#xD;
&#xD;
        Exclusion Criteria:patients with ASA (American Society of Anesthesiologists) Class 4 or 5,&#xD;
        pre-existing hypoxemia (SpO2 &lt;90%), hypotension (systolic blood pressure &lt;90 mm Hg),&#xD;
        bradycardia (HR&lt;50 beats/min), uncontrolled hypertension (SBP &gt;170 mm Hg, diastolic blood&#xD;
        pressure&gt;100 mm Hg), severe renal or liver failure, pregnancy or lactation, allergy to&#xD;
        lidocaine, atrioventricular block, epilepsy, and inability to give informed consen&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shan dong China</last_name>
    <role>Study Chair</role>
    <affiliation>Qilu Hospital of Shandong University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jing Liu, MD</last_name>
    <phone>+86-18560083755</phone>
    <email>liujingqilu@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>yanqing li, phD</last_name>
    <phone>86-531-82169236</phone>
    <email>liyanqing@sdu.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Gastroenterology, Qilu Hospital, Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250012</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>jinan shandong</last_name>
    </contact>
    <contact_backup>
      <last_name>Yanqing li</last_name>
      <phone>86-531-82169236</phone>
      <email>liyanqing@sdu.edu.cn</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shandong University</investigator_affiliation>
    <investigator_full_name>Yanqing Li</investigator_full_name>
    <investigator_title>Vice president of Qilu Hospital</investigator_title>
  </responsible_party>
  <keyword>intravenous lidocaine coloscopy</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</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/NCT04439786
org study id: 2020SDU-QILU-021
nct id: NCT04439786
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
intravenous infusion of lidocaine significantly reduce fatigue and pain and improve the
      patients satisfaction after sedation for colonoscopy.
This study divide patients into two groups, lidocaine group one will be given lidocaine
      intravenously; control group will be given saline . the difference between patients fatigue
      and pain will be compared. and the propofol consumption, pain after infusion of propofol,
      patients, endoscopists and anaesthesist satifaction, the incidence of hypotenstion, hypoxia,
      and bradycardia will aslo be compared between the two groups.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants are randomly assigned to controll group or lidocaine group. Participants of control group are given placebo while participants of lidocaine group are given lidocaine.
primary purpose: Health Services Research
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: fatigue score after colonoscopy
time frame: half a year
description: fatigue were measured on a 0-10VAS at arrival in the recovery room ,30min later
measure: pain socre after colonoscopy
time frame: half a year
description: pain were measured on a 0-10VAS at arrival in the recovery room ,30min later
measure: infusion pain when adminstrate propofol
time frame: half a year
description: infusion pain was divided into no pain, mide pain and severe pain
measure: Safety assessed by the rate of hypoxia during the procedure Safety assessed by the rate of hypoxia during the procedure
time frame: half a year
description: Hypoxia, defined as peripheral oxygen saturation <90% for >10 seconds
measure: Safety assessed by the rate of hypotention during the procedure
time frame: half a year
description: Hypotension, defined as systolic blood pressure <90 mmHg
measure: Safety assessed by the rate of breadycardia during the procedure
time frame: half a year
description: Bradycardia, defined as heart rate <50 beats/min
measure: Safety assessed by the rate of required airway management during the procedure
time frame: half a year
description: Required airway management such as jaw lifting, mask ventilation, or tracheal intubation in severe hypoxia Required airway management such as jaw lifting, mask ventilation, or tracheal intubation in severe hypoxia
measure: Safety assessed by the rate of involuntary movement
time frame: half a year
description: Involuntary movements, defined as unconscious movements requiring restraint or severe limb movement
measure: endoscopists satisfaction assessed by the performer
time frame: half a year
description: the endoscopists satisfacition score were assessed on a 0-10VAS after the procedure
measure: patient satisfaction assessed by the patient
time frame: half a year
description: the patient satisfacition score were assessed on a 0-10VAS 30mins after the procedure
measure: anesthetist satisfaction assessed by the anesthestist
time frame: half a year
description: the anesthetist satisfacition score were assessed on a 0-10VAS after the procedure
arm group label: control group
arm group type: Placebo Comparator
description: the control group will be given the same volume of saline as the experimental group
arm group label: lidocaine group
arm group type: Experimental
description: the experimental group will be given l-1.5mg lidocaine and then 2mg/kg/h
intervention type: Drug
intervention name: placebo
description: the control group will be given the same volume of saline.
arm group label: control group
other name: saline
intervention type: Drug
intervention name: lidocaine
description: the experimental group will be given 1-1.5mg/kg lidocaine and then 2mg/kg/h
arm group label: lidocaine group
other name: Compound Lidocaine Hydrochloride Injiection
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shan dong China
role: Study Chair
affiliation: Qilu Hospital of Shandong University
last name: Jing Liu, MD
phone: +86-18560083755
email: liujingqilu@126.com
last name: yanqing li, phD
phone: 86-531-82169236
email: liyanqing@sdu.edu.cn
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shandong University
investigator full name: Yanqing Li
investigator title: Vice president of Qilu Hospital
mesh term: Lidocaine