<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/NCT04410211</url>
  </required_header>
  <id_info>
    <org_study_id>2018321-6154</org_study_id>
    <nct_id>NCT04410211</nct_id>
  </id_info>
  <brief_title>Comparison Between Two Types of Sedation for Elective Upper Endoscopy Procedures</brief_title>
  <official_title>A Comparative Study Between Inhalational Sevoflurane Sedation With Intravenous Midazolam Sedation for Upper Endoscopy Procedure.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Malaya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Malaya</source>
  <oversight_info>
    <has_dmc>No</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>
      Sedation is defined as the act of administrating a sedative drug to produce a state of calm&#xD;
      or sleep. Sedation is commonly given to a patient in hospital settings to provide a tolerable&#xD;
      and pleasant experience by relieving anxiety, pain and discomfort, as well as to expedite the&#xD;
      duration of the procedure. Moderate sedation (conscious sedation) is the preferred state of&#xD;
      sedation, whereby self-maintenance of ventilation and hemodynamic stability is achieved.&#xD;
&#xD;
      The primary objective of this study is to determine if inhalational Sevoflurane is a more&#xD;
      superior sedative agent in terms of faster psychomotor recovery and time taken to fulfil&#xD;
      discharge criteria when compared with intravenous Midazolam sedation.&#xD;
&#xD;
      Secondary objective is to determine if inhalational Sevoflurane sedation has better patient's&#xD;
      and endoscopist's satisfaction when compared with intravenous Midazolam sedation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized controlled trial study was done on patients undergoing elective upper&#xD;
      gastrointestinal endoscopy in a single tertiary Centre in Malaysia. The study was approved by&#xD;
      University Malaya Medical Centre medical research ethics committee. All patients gave written&#xD;
      and informed consent. Patients were fasted, and three psychometric tests were performed as a&#xD;
      baseline before sedation. Patients were randomly allocated to either receive IV Midazolam&#xD;
      (Group M) or inhalational Sevoflurane (Group S) via nasal mask. Standard monitoring was&#xD;
      applied. Patients in Sevoflurane group received the inhalational agent via a nasal mask with&#xD;
      stepwise increment until and Observed Assessment of Alertness/Sedation Scale of 3 or maximum&#xD;
      1.0 minimum alveolar concentration was achieved. Patients in Midazolam group were given a&#xD;
      stat dose of IV Midazolam 2.5mg. Both groups received 30mcg of IV Fentanyl and lignocaine 1%&#xD;
      gargle prior to the procedure. The unblinded observer monitored the level of sedation and&#xD;
      recorded the patient's vital signs. A second blinded observer performed the psychometric&#xD;
      tests before and at the end of the procedure. He also recorded the time to fulfil discharge&#xD;
      criteria as well as the satisfaction scores from the patient and endoscopist.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">November 30, 2019</completion_date>
  <primary_completion_date type="Actual">November 30, 2019</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>
    <intervention_model_description>Patients are randomized to either the Sevoflurane sedation arm or the Midazolam sedation arm based on a randomizer application and the selections are placed in a non-transparent envelope. Once a patient fulfills the eligibility to be recruited in the study, one envelope will be taken to see which arm will the patient be recruited into. Neither the patient nor the investigator will know.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Patients are randomized to either the Sevoflurane sedation arm or the Midazolam sedation arm based on a randomizer application and the selections are placed in a non-transparent envelope. Once a patient fulfills the eligibility to be recruited in the study, one envelope will be taken to see which arm will the patient be recruited into. Neither the patient nor the investigator will know.&#xD;
Two investigators will be selected to participate in this study, whereby one of the investigators who will be providing the care will not be masked. The other investigator who assess the pre and post procedure outcome will be masked from knowing which method is used.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Psychomotor recovery time</measure>
    <time_frame>30 minutes from completion of procedure</time_frame>
    <description>Pre procedure psychomotor tests baseline scores will be obtained and compared with post procedure scores. Time to achieve baseline recovery scores will be taken and used to compare between the two sedative agents.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time taken to fulfil discharge criteria</measure>
    <time_frame>One day</time_frame>
    <description>Patient would have to fulfil a set of discharge criteria to ensure that patient is safe for discharge.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient and endoscopists satisfaction</measure>
    <time_frame>Post procedure on the same setting not more than one day duration</time_frame>
    <description>Patient will answer a set of questionnaires to gauge the satisfaction of the sedation agent. Endoscopists will score their satisfaction with a scale of 1 to 10, with 1 - 3 being (dissatisfied), 4-6 (satisfied), and 7 - 10 (very satisfied)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Gastro Esophageal Reflux</condition>
  <condition>Gastric Ulcer</condition>
  <condition>Sedation Complication</condition>
  <arm_group>
    <arm_group_label>Group S (inhalational Sevoflurane sedation)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The inhalational anaesthetic agent and oxygen will be delivered via an anaesthetic circuit with a vaporizer (Sevotec 3, Ohmeda, Streeton UK) with a nasal mask.&#xD;
Patients who are allocated for Sevoflurane will be given initial oxygen flow of 8L/min and then Sevoflurane was introduced at a concentration of 0.2% and was increased stepwise by 02% for every 30s up to a maximum of 1.0 minimum alveolar concentration (MAC; 2.05% end tidal). Patient's deepest sedation was recorded and adjusted to achieve optimal Observer's Assessment of Alertness/ Sedation Scale (OAAS) score of 3.&#xD;
Inadequate or over sedation was treated by reducing or increasing the Sevoflurane concentration dial by 0.2 - 0.6% until the desired effect is reached.&#xD;
Full vital signs monitoring are done for every participant</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group M (Intravenous Midazolam sedation)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients who are allocated for Midazolam will be given the similar nasal mask delivering 8L/min oxygen. However, Sevoflurane will not be introduced to these patients.&#xD;
Midazolam is titrated slowly to achieve OAAS score of 3 but no more than 2.5mg is to be given within 2 minutes period to patients selected to be in Midazolam group.&#xD;
Inadequate sedation is treated by giving slow titration of the medication based on the unblinded observer's judgement. Over sedation is treated by withholding the midazolam and continuing oxygen supplementation until the patient returned to the desired sedation level. No other sedative agents are allowed to be given to the patient or else patient will be excluded from this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevoflurane</intervention_name>
    <description>Incidence of side effects such as excitation, headache, apnea, airway obstructions are recorded. Patients who experiences severe excitation disinhibition as defined in the investigator's opinion as agitation. Uncontrollable patient movements that causes unsafe procedural conditions and conversion to general anaesthesia is needed&#xD;
Post procedural recovery scoring are taken which includes:&#xD;
Time taken from the point that the procedure ended to the first OAAS score of 5&#xD;
Time taken from (a) to meeting discharge eligilibility&#xD;
Pre and post procedure pyschometric test (delayed and immediate memory test, posting box test and Stroop test) will be done and compared by the blinded observer/investigator</description>
    <arm_group_label>Group S (inhalational Sevoflurane sedation)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midazolam injection</intervention_name>
    <description>Incidence of side effects such as excitation, headache, apnea, airway obstructions are recorded. Patients who experiences severe excitation disinhibition as defined in the investigator's opinion as agitation. Uncontrollable patient movements that causes unsafe procedural conditions and conversion to general anaesthesia is needed&#xD;
Post procedural recovery scoring are taken which includes:&#xD;
Time taken from the point that the procedure ended to the first OAAS score of 5&#xD;
Time taken from (a) to meeting discharge eligilibility&#xD;
Pre and post procedure pyschometric test (delayed and immediate memory test, posting box test and Stroop test) will be done and compared by the blinded observer/investigator.</description>
    <arm_group_label>Group M (Intravenous Midazolam sedation)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I to II&#xD;
&#xD;
          -  Patients who are not taking sedative agents prior to procedure.&#xD;
&#xD;
          -  Patients who are able to give consent for the procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with ischaemic heart disease, respiratory diseases and cerebrovascular&#xD;
             disease.&#xD;
&#xD;
          -  Patients who are taking opioid or sedative medications 24 hours before procedure.&#xD;
&#xD;
          -  Patients with previous history of adverse effects to Sevoflurane or Midazolam.&#xD;
&#xD;
          -  Pregnant patients.&#xD;
&#xD;
          -  Patients with airway obstructions.&#xD;
&#xD;
          -  Patients with features of difficult airway such as limited neck extension, small mouth&#xD;
             opening of less than 3 cm, mallampati score of more than 3.&#xD;
&#xD;
          -  Patients who are at risk of aspiration. Impaired gag reflex, presence of neurological&#xD;
             disorders and impaired physical mobility.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>PEK LI GAN, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Malaya</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Malaya Medical Centre</name>
      <address>
        <city>Kuala Lumpur</city>
        <state>WP Kuala Lumpur</state>
        <zip>59100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>May 26, 2020</last_update_submitted>
  <last_update_submitted_qc>May 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Malaya</investigator_affiliation>
    <investigator_full_name>Dr Gan Pek Li</investigator_full_name>
    <investigator_title>Trainee in Anaesthesiology and Critical Care</investigator_title>
  </responsible_party>
  <keyword>Sevoflurane</keyword>
  <keyword>Midazolam</keyword>
  <keyword>upper endoscopy</keyword>
  <keyword>recovery</keyword>
  <keyword>discharge time</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroesophageal Reflux</mesh_term>
    <mesh_term>Stomach Ulcer</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Midazolam</mesh_term>
    <mesh_term>Sevoflurane</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>6 months after publication</ipd_time_frame>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 21, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT04410211/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04410211
org study id: 2018321-6154
nct id: NCT04410211
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sedation is defined as the act of administrating a sedative drug to produce a state of calm
      or sleep. Sedation is commonly given to a patient in hospital settings to provide a tolerable
      and pleasant experience by relieving anxiety, pain and discomfort, as well as to expedite the
      duration of the procedure. Moderate sedation (conscious sedation) is the preferred state of
      sedation, whereby self-maintenance of ventilation and hemodynamic stability is achieved.

      The primary objective of this study is to determine if inhalational Sevoflurane is a more
      superior sedative agent in terms of faster psychomotor recovery and time taken to fulfil
      discharge criteria when compared with intravenous Midazolam sedation.

      Secondary objective is to determine if inhalational Sevoflurane sedation has better patient's
      and endoscopist's satisfaction when compared with intravenous Midazolam sedation.
A randomized controlled trial study was done on patients undergoing elective upper
      gastrointestinal endoscopy in a single tertiary Centre in Malaysia. The study was approved by
      University Malaya Medical Centre medical research ethics committee. All patients gave written
      and informed consent. Patients were fasted, and three psychometric tests were performed as a
      baseline before sedation. Patients were randomly allocated to either receive IV Midazolam
      (Group M) or inhalational Sevoflurane (Group S) via nasal mask. Standard monitoring was
      applied. Patients in Sevoflurane group received the inhalational agent via a nasal mask with
      stepwise increment until and Observed Assessment of Alertness/Sedation Scale of 3 or maximum
      1.0 minimum alveolar concentration was achieved. Patients in Midazolam group were given a
      stat dose of IV Midazolam 2.5mg. Both groups received 30mcg of IV Fentanyl and lignocaine 1%
      gargle prior to the procedure. The unblinded observer monitored the level of sedation and
      recorded the patient's vital signs. A second blinded observer performed the psychometric
      tests before and at the end of the procedure. He also recorded the time to fulfil discharge
      criteria as well as the satisfaction scores from the patient and endoscopist.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients are randomized to either the Sevoflurane sedation arm or the Midazolam sedation arm based on a randomizer application and the selections are placed in a non-transparent envelope. Once a patient fulfills the eligibility to be recruited in the study, one envelope will be taken to see which arm will the patient be recruited into. Neither the patient nor the investigator will know.
primary purpose: Supportive Care
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Patients are randomized to either the Sevoflurane sedation arm or the Midazolam sedation arm based on a randomizer application and the selections are placed in a non-transparent envelope. Once a patient fulfills the eligibility to be recruited in the study, one envelope will be taken to see which arm will the patient be recruited into. Neither the patient nor the investigator will know.
Two investigators will be selected to participate in this study, whereby one of the investigators who will be providing the care will not be masked. The other investigator who assess the pre and post procedure outcome will be masked from knowing which method is used.
measure: Psychomotor recovery time
time frame: 30 minutes from completion of procedure
description: Pre procedure psychomotor tests baseline scores will be obtained and compared with post procedure scores. Time to achieve baseline recovery scores will be taken and used to compare between the two sedative agents.
measure: Time taken to fulfil discharge criteria
time frame: One day
description: Patient would have to fulfil a set of discharge criteria to ensure that patient is safe for discharge.
measure: Patient and endoscopists satisfaction
time frame: Post procedure on the same setting not more than one day duration
description: Patient will answer a set of questionnaires to gauge the satisfaction of the sedation agent. Endoscopists will score their satisfaction with a scale of 1 to 10, with 1 - 3 being (dissatisfied), 4-6 (satisfied), and 7 - 10 (very satisfied)
arm group label: Group S (inhalational Sevoflurane sedation)
arm group type: Active Comparator
description: The inhalational anaesthetic agent and oxygen will be delivered via an anaesthetic circuit with a vaporizer (Sevotec 3, Ohmeda, Streeton UK) with a nasal mask.
Patients who are allocated for Sevoflurane will be given initial oxygen flow of 8L/min and then Sevoflurane was introduced at a concentration of 0.2% and was increased stepwise by 02% for every 30s up to a maximum of 1.0 minimum alveolar concentration (MAC; 2.05% end tidal). Patient's deepest sedation was recorded and adjusted to achieve optimal Observer's Assessment of Alertness/ Sedation Scale (OAAS) score of 3.
Inadequate or over sedation was treated by reducing or increasing the Sevoflurane concentration dial by 0.2 - 0.6% until the desired effect is reached.
Full vital signs monitoring are done for every participant
arm group label: Group M (Intravenous Midazolam sedation)
arm group type: Active Comparator
description: Patients who are allocated for Midazolam will be given the similar nasal mask delivering 8L/min oxygen. However, Sevoflurane will not be introduced to these patients.
Midazolam is titrated slowly to achieve OAAS score of 3 but no more than 2.5mg is to be given within 2 minutes period to patients selected to be in Midazolam group.
Inadequate sedation is treated by giving slow titration of the medication based on the unblinded observer's judgement. Over sedation is treated by withholding the midazolam and continuing oxygen supplementation until the patient returned to the desired sedation level. No other sedative agents are allowed to be given to the patient or else patient will be excluded from this study.
intervention type: Drug
intervention name: Sevoflurane
description: Incidence of side effects such as excitation, headache, apnea, airway obstructions are recorded. Patients who experiences severe excitation disinhibition as defined in the investigator's opinion as agitation. Uncontrollable patient movements that causes unsafe procedural conditions and conversion to general anaesthesia is needed
Post procedural recovery scoring are taken which includes:
Time taken from the point that the procedure ended to the first OAAS score of 5
Time taken from (a) to meeting discharge eligilibility
Pre and post procedure pyschometric test (delayed and immediate memory test, posting box test and Stroop test) will be done and compared by the blinded observer/investigator
arm group label: Group S (inhalational Sevoflurane sedation)
intervention type: Drug
intervention name: Midazolam injection
description: Incidence of side effects such as excitation, headache, apnea, airway obstructions are recorded. Patients who experiences severe excitation disinhibition as defined in the investigator's opinion as agitation. Uncontrollable patient movements that causes unsafe procedural conditions and conversion to general anaesthesia is needed
Post procedural recovery scoring are taken which includes:
Time taken from the point that the procedure ended to the first OAAS score of 5
Time taken from (a) to meeting discharge eligilibility
Pre and post procedure pyschometric test (delayed and immediate memory test, posting box test and Stroop test) will be done and compared by the blinded observer/investigator.
arm group label: Group M (Intravenous Midazolam sedation)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: PEK LI GAN, MBBS
role: Principal Investigator
affiliation: University Malaya
facility: 
country: Malaysia
responsible party type: Principal Investigator
investigator affiliation: University of Malaya
investigator full name: Dr Gan Pek Li
investigator title: Trainee in Anaesthesiology and Critical Care
mesh term: Gastroesophageal Reflux
mesh term: Stomach Ulcer
mesh term: Midazolam
mesh term: Sevoflurane
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: 6 months after publication
provided document: 