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/NCT06015074</url>
    </required_header>
    <id_info>
      <org_study_id>C-Anesthesia</org_study_id>
      <nct_id>NCT06015074</nct_id>
    </id_info>
    <brief_title>Ciprofol vs Propofol for Reducing Hypoxia Incidence in ERCP</brief_title>
    <official_title>Ciprofol vs Propofol for Reducing Hypoxia Incidence in Intravenous Anesthesia During Elective Endoscopic Retrograde Cholangiopancreatography-A Randomized Double Blinded Controlled Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>RenJi Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>RenJi Hospital</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>
        Intravenous anesthesia has been widely used in endoscopic retrograde cholangiopancreatography&#xD;
        (ERCP). In the past decade, many practices have been carried out under the propofol-based&#xD;
        monitored anesthesia care without endotracheal intubation in patients undergoing ERCP.&#xD;
  &#xD;
        Ciprofol is a newly developed intravenous anesthetic with a potency 4-5 times than that of&#xD;
        propofol. Ciprofol seems a promising anesthetic agent for intravenous anesthesia but the&#xD;
        evidence supported its application in ERCP is still limited.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective, randomized, double-blind trial comparing the incidence of hypoxia in&#xD;
        the propofol versus ciprofol intravenous Anesthesia. A total 124 patients will be recruited&#xD;
        and randomly assigned to either the propofol or the ciprofol group. The primary outcome is&#xD;
        the proportion of patients experiencing hypoxia. The secondary outcomes include: the&#xD;
        incidence of hypotension in perioperative period; the incidence of conversion from&#xD;
        intravenous anesthesia to general anesthesia; sedation-related procedure interruption; CO2&#xD;
        accumulation during operation; Patients' satisfaction with anesthesia and postoperative&#xD;
        recovery / VAS score / incidence of nausea and vomiting; the incidence of intraoperative and&#xD;
        postoperative adverse events, such as adverse excretion, severe hypoxemia, severe circulatory&#xD;
        dysfunction; length of stay and mortality within 30 days after operation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 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>Other</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>the incidence of hypoxia</measure>
      <time_frame>from the induction of anesthesia to the patient leaving the postanesthesia care unit，about an average of 1.5 hours</time_frame>
      <description>the definition of hypoxemia: any event of SpO2 (oxygen saturation measured by pulse oximetry) &lt; 90%</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>the incidence of hypercapnia</measure>
      <time_frame>5 minutes each time（base line, 10 minutes after beginning of surgery, completion of surgery, 10 minutes after awakening）</time_frame>
      <description>arterial carbon dioxide partial pressure（PaCO2）&gt;50mmHg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the incidence of hypotension</measure>
      <time_frame>from the induction of anesthesia to the patient leaving the postanesthesia care unit，about an average of 1.5 hours</time_frame>
      <description>invasive systolic pressure&lt;90mmHg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>sedation-related procedure interruption</measure>
      <time_frame>from the induction of anesthesia to completion of ERCP, about 30 minutes</time_frame>
      <description>the incidence of interruption of procedure due to intolerance or severe adverse events</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>conversion from intravenous anesthesia to general anesthesia</measure>
      <time_frame>from the induction of anesthesia to completion of ERCP, about 30 minutes</time_frame>
      <description>the incidence of conversion from intravenous anesthesia to general anesthesia due to intolerance or severe adverse events</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>patient satisfaction score</measure>
      <time_frame>5 minutes</time_frame>
      <description>Patients' satisfaction score is measured by patient recovery satisfaction score, from -33 the worst to 33 the best.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>visual analog scale (VAS) scores</measure>
      <time_frame>30 seconds</time_frame>
      <description>perioperative pain is measured by visual analog scale (VAS) scores，from painless score 0 to the imagined most severe pain score 10</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>length of stay</measure>
      <time_frame>2-7days</time_frame>
      <description>length of stay in hospital</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the incidence of postoperative adverse bile excretion</measure>
      <time_frame>30 days after operation</time_frame>
      <description>patients with symptoms or signs of postoperative adverse bile excretion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the incidence of severe postoperative hypoxia</measure>
      <time_frame>30 days after operation</time_frame>
      <description>patients with symptoms or signs of severe postoperative hypoxia</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the incidence of severe postoperative circulatory disfunction</measure>
      <time_frame>30 days after operation</time_frame>
      <description>patients with symptoms or signs of severe postoperative circulatory disfunction</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the incidence of mortality within 30 days after operation</measure>
      <time_frame>30 days after operation</time_frame>
      <description>mortality within 30 days after operation</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">124</enrollment>
    <condition>Anesthesia; Adverse Effect</condition>
    <condition>Biliary Tract Diseases</condition>
    <arm_group>
      <arm_group_label>Propofol group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>patients in Propofol group receive sufentanil+ propofol</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Ciprofol group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>patients in Ciprofol group receive sufentanil+ ciprofol</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Propofol</intervention_name>
      <description>patients in Propofol group receive sufentanil(0.1ug/kg)+ propofol (1.5-2mg/kg) for anesthesia induction, and continuous infusion of propofol 5mg/kg/h for anesthesia maintain.</description>
      <arm_group_label>Propofol group</arm_group_label>
      <other_name>Fresenius Kabi，China</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ciprofol</intervention_name>
      <description>patients in Ciprofol group receive sufentanil(0.1ug/kg)+ ciprofol(0.4-0.5mg/kg) for anesthesia induction, and continuous infusion of ciprofol 0.8mg/kg/h for anesthesia maintain.</description>
      <arm_group_label>Ciprofol group</arm_group_label>
      <other_name>Haisike，China</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients undergoing ERCP, ASA I-III&#xD;
  &#xD;
            -  normal renal function&#xD;
  &#xD;
            -  BMI ≥ 18kg/m 2 and ≤ 30kg/m 2&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previous serious cerebrovascular accidents and other neurological diseases&#xD;
  &#xD;
            -  mental diseases, long-term use of drugs that affect the function of the central&#xD;
               nervous system, benzodiazepines or opioids&#xD;
  &#xD;
            -  history of anesthetic allergy&#xD;
  &#xD;
            -  preoperative hypotension or preoperative SP02 &lt; 90%, or chronic respiratory failure&#xD;
  &#xD;
            -  patients suspected of having difficult airways&#xD;
  &#xD;
            -  screening for drug addiction and alcohol abuse within the first 3 months (&gt; =&#xD;
               6standarddrinks/day)&#xD;
  &#xD;
            -  patients diagnosed with severe cardiopulmonary disease, or respiratory or respiratory&#xD;
               diseases such as sleep apnea syndrome;&#xD;
  &#xD;
            -  bradycardia or atrioventricular block.&#xD;
  &#xD;
            -  participate in other clinical trials within 4 weeks;&#xD;
  &#xD;
            -  cognitive or communication abnormalities determined by the researchers;&#xD;
  &#xD;
            -  emergent and critical conditions during the operation;&#xD;
  &#xD;
            -  other conditions that the researchers believe are not suitable to participate in the&#xD;
               study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Peiying Li, Doctor</last_name>
      <role>Study Director</role>
      <affiliation>Clinial Research Center, Renji Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Yu Weifeng, Doctor</last_name>
      <role>Study Chair</role>
      <affiliation>Department of Anesthesiology, Renji Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Zheng Li, Master</last_name>
      <role>Study Director</role>
      <affiliation>Department of Anesthesiology, Renji Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Yanhua Zhao, Doctor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Anesthesiology, Renji Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Yifeng Qu, Master</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Anesthesiology, Renji Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Kun Luo, Master</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Anesthesiology, Renji Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Guangyan Wang</last_name>
      <role>Principal Investigator</role>
      <affiliation>Operating Room，Renji Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Teng Wang</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Anesthesiology, Renji Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Huichen Zhu, Master</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Anesthesiology, Renji Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Jing Gao, Doctor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Clinial Research Center, Renji Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Peiying Li, Doctor</last_name>
      <phone>15800616866</phone>
      <email>peiyingli.md@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Renji Hospital, Shanghai Jiao Tong University School of Medicine,</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200127</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Peiying Li, Doctor</last_name>
        <phone>+8615800616866</phone>
        <email>peiyingli.md@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Adler DG, Baron TH, Davila RE, Egan J, Hirota WK, Leighton JA, Qureshi W, Rajan E, Zuckerman MJ, Fanelli R, Wheeler-Harbaugh J, Faigel DO; Standards of Practice Committee of American Society for Gastrointestinal Endoscopy. ASGE guideline: the role of ERCP in diseases of the biliary tract and the pancreas. Gastrointest Endosc. 2005 Jul;62(1):1-8. doi: 10.1016/j.gie.2005.04.015. No abstract available.</citation>
      <PMID>15990812</PMID>
    </reference>
    <reference>
      <citation>Alzanbagi AB, Jilani TL, Qureshi LA, Ibrahim IM, Tashkandi AMS, Elshrief EEA, Khan MS, Abdelhalim MAH, Zahrani SA, Mohamed WMK, Nageeb AM, Abbushi B, Shariff MK. Randomized trial comparing general anesthesia with anesthesiologist-administered deep sedation for ERCP in average-risk patients. Gastrointest Endosc. 2022 Dec;96(6):983-990.e2. doi: 10.1016/j.gie.2022.06.003. Epub 2022 Jun 9.</citation>
      <PMID>35690151</PMID>
    </reference>
    <reference>
      <citation>Cote GA, Hovis RM, Ansstas MA, Waldbaum L, Azar RR, Early DS, Edmundowicz SA, Mullady DK, Jonnalagadda SS. Incidence of sedation-related complications with propofol use during advanced endoscopic procedures. Clin Gastroenterol Hepatol. 2010 Feb;8(2):137-42. doi: 10.1016/j.cgh.2009.07.008. Epub 2009 Jul 14.</citation>
      <PMID>19607937</PMID>
    </reference>
    <reference>
      <citation>Amornyotin S, Srikureja W, Chalayonnavin W, Kongphlay S. Dose requirement and complications of diluted and undiluted propofol for deep sedation in endoscopic retrograde cholangiopancreatography. Hepatobiliary Pancreat Dis Int. 2011 Jun;10(3):313-8. doi: 10.1016/s1499-3872(11)60052-0.</citation>
      <PMID>21669577</PMID>
    </reference>
    <reference>
      <citation>Qadeer MA, Vargo JJ, Dumot JA, Lopez R, Trolli PA, Stevens T, Parsi MA, Sanaka MR, Zuccaro G. Capnographic monitoring of respiratory activity improves safety of sedation for endoscopic cholangiopancreatography and ultrasonography. Gastroenterology. 2009 May;136(5):1568-76; quiz 1819-20. doi: 10.1053/j.gastro.2009.02.004.</citation>
      <PMID>19422079</PMID>
    </reference>
    <reference>
      <citation>Vargo JJ, Zuccaro G Jr, Dumot JA, Conwell DL, Morrow JB, Shay SS. Automated graphic assessment of respiratory activity is superior to pulse oximetry and visual assessment for the detection of early respiratory depression during therapeutic upper endoscopy. Gastrointest Endosc. 2002 Jun;55(7):826-31. doi: 10.1067/mge.2002.124208.</citation>
      <PMID>12024135</PMID>
    </reference>
    <reference>
      <citation>Paspatis GA, Manolaraki MM, Vardas E, Theodoropoulou A, Chlouverakis G. Deep sedation for endoscopic retrograde cholangiopancreatography: intravenous propofol alone versus intravenous propofol with oral midazolam premedication. Endoscopy. 2008 Apr;40(4):308-13. doi: 10.1055/s-2007-995346. Epub 2007 Dec 5.</citation>
      <PMID>18058653</PMID>
    </reference>
    <reference>
      <citation>Vargo JJ, Zuccaro G Jr, Dumot JA, Shermock KM, Morrow JB, Conwell DL, Trolli PA, Maurer WG. Gastroenterologist-administered propofol versus meperidine and midazolam for advanced upper endoscopy: a prospective, randomized trial. Gastroenterology. 2002 Jul;123(1):8-16. doi: 10.1053/gast.2002.34232.</citation>
      <PMID>12105827</PMID>
    </reference>
    <reference>
      <citation>Liu Y, Yu X, Zhu D, Zeng J, Lin Q, Zang B, Chen C, Liu N, Liu X, Gao W, Guan X. Safety and efficacy of ciprofol vs. propofol for sedation in intensive care unit patients with mechanical ventilation: a multi-center, open label, randomized, phase 2 trial. Chin Med J (Engl). 2022 May 5;135(9):1043-1051. doi: 10.1097/CM9.0000000000001912.</citation>
      <PMID>34924506</PMID>
    </reference>
    <reference>
      <citation>Liu Y, Chen C, Liu N, Tong L, Nie Y, Wu J, Liu X, Gao W, Tang L, Guan X. Efficacy and Safety of Ciprofol Sedation in ICU Patients with Mechanical Ventilation: A Clinical Trial Study Protocol. Adv Ther. 2021 Oct;38(10):5412-5423. doi: 10.1007/s12325-021-01877-6. Epub 2021 Aug 21.</citation>
      <PMID>34417990</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Ciprofol</keyword>
    <keyword>Propofol</keyword>
    <keyword>Intravenous Anesthesia</keyword>
    <keyword>Elective Endoscopic Retrograde Cholangiopancreatography</keyword>
    <keyword>Hypoxia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Biliary Tract Diseases</mesh_term>
      <mesh_term>Hypoxia</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Propofol</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06015074
  org study id: C-Anesthesia
  nct id: NCT06015074
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Intravenous anesthesia has been widely used in endoscopic retrograde cholangiopancreatography
        (ERCP). In the past decade, many practices have been carried out under the propofol-based
        monitored anesthesia care without endotracheal intubation in patients undergoing ERCP.
  
        Ciprofol is a newly developed intravenous anesthetic with a potency 4-5 times than that of
        propofol. Ciprofol seems a promising anesthetic agent for intravenous anesthesia but the
        evidence supported its application in ERCP is still limited.
  This is a prospective, randomized, double-blind trial comparing the incidence of hypoxia in
        the propofol versus ciprofol intravenous Anesthesia. A total 124 patients will be recruited
        and randomly assigned to either the propofol or the ciprofol group. The primary outcome is
        the proportion of patients experiencing hypoxia. The secondary outcomes include: the
        incidence of hypotension in perioperative period; the incidence of conversion from
        intravenous anesthesia to general anesthesia; sedation-related procedure interruption; CO2
        accumulation during operation; Patients' satisfaction with anesthesia and postoperative
        recovery / VAS score / incidence of nausea and vomiting; the incidence of intraoperative and
        postoperative adverse events, such as adverse excretion, severe hypoxemia, severe circulatory
        dysfunction; length of stay and mortality within 30 days after operation.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Double (Participant, Investigator)
  measure: the incidence of hypoxia
  time frame: from the induction of anesthesia to the patient leaving the postanesthesia care unit，about an average of 1.5 hours
  description: the definition of hypoxemia: any event of SpO2 (oxygen saturation measured by pulse oximetry) < 90%
  measure: the incidence of hypercapnia
  time frame: 5 minutes each time（base line, 10 minutes after beginning of surgery, completion of surgery, 10 minutes after awakening）
  description: arterial carbon dioxide partial pressure（PaCO2）>50mmHg
  measure: the incidence of hypotension
  time frame: from the induction of anesthesia to the patient leaving the postanesthesia care unit，about an average of 1.5 hours
  description: invasive systolic pressure<90mmHg
  measure: sedation-related procedure interruption
  time frame: from the induction of anesthesia to completion of ERCP, about 30 minutes
  description: the incidence of interruption of procedure due to intolerance or severe adverse events
  measure: conversion from intravenous anesthesia to general anesthesia
  time frame: from the induction of anesthesia to completion of ERCP, about 30 minutes
  description: the incidence of conversion from intravenous anesthesia to general anesthesia due to intolerance or severe adverse events
  measure: patient satisfaction score
  time frame: 5 minutes
  description: Patients' satisfaction score is measured by patient recovery satisfaction score, from -33 the worst to 33 the best.
  measure: visual analog scale (VAS) scores
  time frame: 30 seconds
  description: perioperative pain is measured by visual analog scale (VAS) scores，from painless score 0 to the imagined most severe pain score 10
  measure: length of stay
  time frame: 2-7days
  description: length of stay in hospital
  measure: the incidence of postoperative adverse bile excretion
  time frame: 30 days after operation
  description: patients with symptoms or signs of postoperative adverse bile excretion
  measure: the incidence of severe postoperative hypoxia
  time frame: 30 days after operation
  description: patients with symptoms or signs of severe postoperative hypoxia
  measure: the incidence of severe postoperative circulatory disfunction
  time frame: 30 days after operation
  description: patients with symptoms or signs of severe postoperative circulatory disfunction
  measure: the incidence of mortality within 30 days after operation
  time frame: 30 days after operation
  description: mortality within 30 days after operation
  arm group label: Propofol group
  arm group type: Active Comparator
  description: patients in Propofol group receive sufentanil+ propofol
  arm group label: Ciprofol group
  arm group type: Experimental
  description: patients in Ciprofol group receive sufentanil+ ciprofol
  intervention type: Drug
  intervention name: Propofol
  description: patients in Propofol group receive sufentanil(0.1ug/kg)+ propofol (1.5-2mg/kg) for anesthesia induction, and continuous infusion of propofol 5mg/kg/h for anesthesia maintain.
  arm group label: Propofol group
  other name: Fresenius Kabi，China
  intervention type: Drug
  intervention name: Ciprofol
  description: patients in Ciprofol group receive sufentanil(0.1ug/kg)+ ciprofol(0.4-0.5mg/kg) for anesthesia induction, and continuous infusion of ciprofol 0.8mg/kg/h for anesthesia maintain.
  arm group label: Ciprofol group
  other name: Haisike，China
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Peiying Li, Doctor
  role: Study Director
  affiliation: Clinial Research Center, Renji Hospital
  last name: Yu Weifeng, Doctor
  role: Study Chair
  affiliation: Department of Anesthesiology, Renji Hospital
  last name: Zheng Li, Master
  role: Study Director
  affiliation: Department of Anesthesiology, Renji Hospital
  last name: Yanhua Zhao, Doctor
  role: Principal Investigator
  affiliation: Department of Anesthesiology, Renji Hospital
  last name: Yifeng Qu, Master
  role: Principal Investigator
  affiliation: Department of Anesthesiology, Renji Hospital
  last name: Kun Luo, Master
  role: Principal Investigator
  affiliation: Department of Anesthesiology, Renji Hospital
  last name: Guangyan Wang
  role: Principal Investigator
  affiliation: Operating Room，Renji Hospital
  last name: Teng Wang
  role: Principal Investigator
  affiliation: Department of Anesthesiology, Renji Hospital
  last name: Huichen Zhu, Master
  role: Principal Investigator
  affiliation: Department of Anesthesiology, Renji Hospital
  last name: Jing Gao, Doctor
  role: Principal Investigator
  affiliation: Clinial Research Center, Renji Hospital
  last name: Peiying Li, Doctor
  phone: 15800616866
  email: peiyingli.md@gmail.com
  facility: 
  contact: 
  country: China
  citation: Adler DG, Baron TH, Davila RE, Egan J, Hirota WK, Leighton JA, Qureshi W, Rajan E, Zuckerman MJ, Fanelli R, Wheeler-Harbaugh J, Faigel DO; Standards of Practice Committee of American Society for Gastrointestinal Endoscopy. ASGE guideline: the role of ERCP in diseases of the biliary tract and the pancreas. Gastrointest Endosc. 2005 Jul;62(1):1-8. doi: 10.1016/j.gie.2005.04.015. No abstract available.
  PMID: 15990812
  citation: Alzanbagi AB, Jilani TL, Qureshi LA, Ibrahim IM, Tashkandi AMS, Elshrief EEA, Khan MS, Abdelhalim MAH, Zahrani SA, Mohamed WMK, Nageeb AM, Abbushi B, Shariff MK. Randomized trial comparing general anesthesia with anesthesiologist-administered deep sedation for ERCP in average-risk patients. Gastrointest Endosc. 2022 Dec;96(6):983-990.e2. doi: 10.1016/j.gie.2022.06.003. Epub 2022 Jun 9.
  PMID: 35690151
  citation: Cote GA, Hovis RM, Ansstas MA, Waldbaum L, Azar RR, Early DS, Edmundowicz SA, Mullady DK, Jonnalagadda SS. Incidence of sedation-related complications with propofol use during advanced endoscopic procedures. Clin Gastroenterol Hepatol. 2010 Feb;8(2):137-42. doi: 10.1016/j.cgh.2009.07.008. Epub 2009 Jul 14.
  PMID: 19607937
  citation: Amornyotin S, Srikureja W, Chalayonnavin W, Kongphlay S. Dose requirement and complications of diluted and undiluted propofol for deep sedation in endoscopic retrograde cholangiopancreatography. Hepatobiliary Pancreat Dis Int. 2011 Jun;10(3):313-8. doi: 10.1016/s1499-3872(11)60052-0.
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  PMID: 34417990
  responsible party type: Sponsor
  mesh term: Biliary Tract Diseases
  mesh term: Hypoxia
  mesh term: Propofol
  sharing ipd: No