<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/NCT04490031</url>
  </required_header>
  <id_info>
    <org_study_id>Hukm</org_study_id>
    <nct_id>NCT04490031</nct_id>
  </id_info>
  <brief_title>Evaluation of Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)</brief_title>
  <official_title>Randomized Control Study Evaluating Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universiti Kebangsaan Malaysia Medical Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universiti Kebangsaan Malaysia Medical Centre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study evaluating the usage of Ketamine as sedative agent in ERCP. The usage of&#xD;
      Ketamine will be compared to the standard sedation in our center, which is Midazolam in&#xD;
      combination with Pethidine as analgesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a double blinded study whereby both the surgeons and patients are blinded from the&#xD;
      sedative agent used. Patients admitted to UKMMC requiring ERCP will randomized into 2 groups&#xD;
      after evaluating the inclusion and exclusion criteria. Patients will be divided into two&#xD;
      arms, Midazolam and Ketamine group respectively. Before the initiation of the the scope,&#xD;
      patient would be given specified dose of sedation accordingly. All the parameters and outcome&#xD;
      would be measured during and after the procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Anticipated">April 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>Both the patients and surgeon will be blinded from knowing the sedative agent</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>depth of sedation</measure>
    <time_frame>1 hour</time_frame>
    <description>based on Ramsay Sedation Scale, from a scale of 1-6.&#xD;
Patient is anxious and agitated or restless, or both&#xD;
Patient is co-operative, oriented, and tranquil&#xD;
Patient responds to commands only&#xD;
Patient exhibits brisk response to light glabellar tap or loud auditory stimulus&#xD;
Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus&#xD;
Patient exhibits no response The aim of sedation is a score of 3-4</description>
  </primary_outcome>
  <primary_outcome>
    <measure>completion rate</measure>
    <time_frame>1 hour</time_frame>
    <description>to evaluate completion rate between Ketamine and Midazolam group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surgeon satisfaction score</measure>
    <time_frame>within 4 hours after completion of ERCP</time_frame>
    <description>subjective scoring of surgeon regarding overall experience of the ERCP from a score of 0-10.&#xD;
0- poor, 5- moderate, 10- excellent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction score</measure>
    <time_frame>within 4 hours after completion of ERCP</time_frame>
    <description>subjective scoring of patients regarding overall experience of the ERCP from a score of 0-10.&#xD;
0- poor, 5- moderate, 10- excellent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>evaluate the occurrence of hypertension, hypotension, bradycardia, tachycardia, hypoxia, respiratory rate abnormality, nausea, vomiting and emergence symptoms</measure>
    <time_frame>24 hours</time_frame>
    <description>recording the adverse events of each sedation.&#xD;
Hypotension: defined as a systolic blood pressure drop greater than 20mmHg to a value less than 90mmHg&#xD;
Hypertension: defined as a systolic blood pressure increase greater than 20mmHg or to a value more than 140mmHg&#xD;
Bradycardia: defined as heart rate less than 50 after the initiation of sedation or decrease in heart rate more than 20 beats per minute&#xD;
Tachycardia: defined as heart rate more than 100 after the initiation of sedation or increase in heart rate more than 20 beats per minute&#xD;
Hypoxia: defined by oxygen saturation less than 95%&#xD;
Respiratory rate abnormality&#xD;
Nausea, vomiting, emergence symptoms</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Ketamine Adverse Reaction</condition>
  <arm_group>
    <arm_group_label>Midazolam group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard sedation for ERCP in UKMMC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ketamine group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine Hydrochloride</intervention_name>
    <description>patient in Ketamine group will be given Ketamine as sedative agent</description>
    <arm_group_label>Ketamine group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Malaysian citizens of who is able to give valid consent&#xD;
&#xD;
          -  Patient planned for ERCP (either emergency or elective)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hypersensitivity towards Ketamine or Midazolam&#xD;
&#xD;
          -  Patient refusal to participate or unable to give consent&#xD;
&#xD;
          -  Increased intracranial pressure, acute stroke (&lt;3 months), intracranial haemorrhage&#xD;
             (&lt;3 months)&#xD;
&#xD;
          -  Uncontrolled hypertension (BP&gt;160/100) and tachycardia (Heart rate &gt;120)&#xD;
&#xD;
          -  Acute myocardial infarction, acute coronary syndrome (&lt;3 months)&#xD;
&#xD;
          -  Tachyarrythmia&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  IVDU or substance abuse patient&#xD;
&#xD;
          -  Patient with history of hallucination&#xD;
&#xD;
          -  Child's Pugh Class C&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ian Chik, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universiti Kebangsaan Malaysia Medical Centre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Norma mohamad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universiti Kebangsaan Malaysia Medical Centre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zamri Zuhdi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universiti Kebangsaan Malaysia Medical Centre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Azlanudin Azman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universiti Kebangsaan Malaysia Medical Centre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Muhammad Hafiz Ismail, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universiti Kebangsaan Malaysia Medical Centre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Muhammad Hafiz Ismail, MBBS</last_name>
    <phone>6016 3354384</phone>
    <email>muhdhafizismail88@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ian Chik, MD</last_name>
    <phone>6012 3243404</phone>
    <email>ianchikmd@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Kebangsaan Malaysia Medical center</name>
      <address>
        <city>Bandar Tun Razak</city>
        <state>Kuala Lumpur</state>
        <zip>56000</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zamri Zuhdi, MD</last_name>
      <phone>6019 2436634</phone>
      <email>zamriz7582@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Ian Chik, MD</last_name>
      <phone>0123243404</phone>
      <email>ianchikmd@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Zamri Zuhdi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Azlanudin Azman, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ian Chik, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Norma Mohamad, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Muhammad Hafiz Ismail, MBBS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>March 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 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>Ketamine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>January 11, 2023</submitted>
    <returned>February 7, 2023</returned>
    <submitted>August 27, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04490031
org study id: Hukm
nct id: NCT04490031
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This is a study evaluating the usage of Ketamine as sedative agent in ERCP. The usage of
      Ketamine will be compared to the standard sedation in our center, which is Midazolam in
      combination with Pethidine as analgesia.
This is a double blinded study whereby both the surgeons and patients are blinded from the
      sedative agent used. Patients admitted to UKMMC requiring ERCP will randomized into 2 groups
      after evaluating the inclusion and exclusion criteria. Patients will be divided into two
      arms, Midazolam and Ketamine group respectively. Before the initiation of the the scope,
      patient would be given specified dose of sedation accordingly. All the parameters and outcome
      would be measured during and after the procedure.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Health Services Research
masking: Double (Participant, Care Provider)
masking description: Both the patients and surgeon will be blinded from knowing the sedative agent
measure: depth of sedation
time frame: 1 hour
description: based on Ramsay Sedation Scale, from a scale of 1-6.
Patient is anxious and agitated or restless, or both
Patient is co-operative, oriented, and tranquil
Patient responds to commands only
Patient exhibits brisk response to light glabellar tap or loud auditory stimulus
Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus
Patient exhibits no response The aim of sedation is a score of 3-4
measure: completion rate
time frame: 1 hour
description: to evaluate completion rate between Ketamine and Midazolam group
measure: Surgeon satisfaction score
time frame: within 4 hours after completion of ERCP
description: subjective scoring of surgeon regarding overall experience of the ERCP from a score of 0-10.
0- poor, 5- moderate, 10- excellent
measure: Patient satisfaction score
time frame: within 4 hours after completion of ERCP
description: subjective scoring of patients regarding overall experience of the ERCP from a score of 0-10.
0- poor, 5- moderate, 10- excellent
measure: evaluate the occurrence of hypertension, hypotension, bradycardia, tachycardia, hypoxia, respiratory rate abnormality, nausea, vomiting and emergence symptoms
time frame: 24 hours
description: recording the adverse events of each sedation.
Hypotension: defined as a systolic blood pressure drop greater than 20mmHg to a value less than 90mmHg
Hypertension: defined as a systolic blood pressure increase greater than 20mmHg or to a value more than 140mmHg
Bradycardia: defined as heart rate less than 50 after the initiation of sedation or decrease in heart rate more than 20 beats per minute
Tachycardia: defined as heart rate more than 100 after the initiation of sedation or increase in heart rate more than 20 beats per minute
Hypoxia: defined by oxygen saturation less than 95%
Respiratory rate abnormality
Nausea, vomiting, emergence symptoms
arm group label: Midazolam group
arm group type: No Intervention
description: Standard sedation for ERCP in UKMMC
arm group label: Ketamine group
arm group type: Experimental
intervention type: Drug
intervention name: Ketamine Hydrochloride
description: patient in Ketamine group will be given Ketamine as sedative agent
arm group label: Ketamine group
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ian Chik, MD
role: Principal Investigator
affiliation: Universiti Kebangsaan Malaysia Medical Centre
last name: Norma mohamad, MD
role: Principal Investigator
affiliation: Universiti Kebangsaan Malaysia Medical Centre
last name: Zamri Zuhdi, MD
role: Principal Investigator
affiliation: Universiti Kebangsaan Malaysia Medical Centre
last name: Azlanudin Azman, MD
role: Principal Investigator
affiliation: Universiti Kebangsaan Malaysia Medical Centre
last name: Muhammad Hafiz Ismail, MD
role: Principal Investigator
affiliation: Universiti Kebangsaan Malaysia Medical Centre
last name: Muhammad Hafiz Ismail, MBBS
phone: 6016 3354384
email: muhdhafizismail88@gmail.com
last name: Ian Chik, MD
phone: 6012 3243404
email: ianchikmd@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Malaysia
responsible party type: Sponsor
mesh term: Ketamine
sharing ipd: No
submitted: January 11, 2023
returned: February 7, 2023
submitted: August 27, 2023