<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/NCT04485117</url>
  </required_header>
  <id_info>
    <org_study_id>BIS Monitoring in Strabismus</org_study_id>
    <nct_id>NCT04485117</nct_id>
  </id_info>
  <brief_title>Propofol Versus Sevoflurane Anesthesia in Pediatric Strabismus Surgery: Feasibility of BIS Monitoring</brief_title>
  <official_title>Propofol Versus Sevoflurane Anesthesia in Pediatric Strabismus Surgery: Feasibility of BIS Monitoring</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sameh Fathy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura 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>
      This study is conducted to evaluate importance of bispectral index (BIS) monitoring in&#xD;
      patients undergoing strabismus surgery when using propofol in comparison to sevoflurane&#xD;
      anesthesia regarding their effects on oculocardiac reflex, intraoperative hemodynamic&#xD;
      stability, emergence agitation, postoperative pain, nausea and vomiting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Strabismus surgery can cause unfavorable side effects during intraoperative and postoperative&#xD;
      periods including increased risk of the oculocardiac reflex, hemodynamic instability,&#xD;
      emergence agitation, postoperative pain, nausea and vomiting. Sevoflurane is an inhalation&#xD;
      anesthetic widely used in pediatric anesthesia with minimal airway irritation. Propofol is an&#xD;
      intravenous sedative-hypnotic agent with amnestic properties that causes loss of&#xD;
      consciousness. Bispectral index monitor provide some more evidence that deeper anesthesia can&#xD;
      provide some protection against the oculocardiac reflex. Therefore, this study is conducted&#xD;
      to evaluate the role of BIS monitoring in comparing the use of propofol and sevoflurane&#xD;
      anesthesia in pediatric strabismus surgery.&#xD;
&#xD;
      This prospective, randomized, comparative clinical study will include 100 children who are&#xD;
      scheduled for elective strabismus surgery under general anesthesia in Mansoura ophthalmology&#xD;
      center. Informed written consent is obtained from parents of all subjects in the study after&#xD;
      ensuring confidentiality. The study protocol is explained to parents of all patients in the&#xD;
      study who are kept fasting prior to surgery. Patients are randomly assigned to two equal&#xD;
      groups according to computer-generated table of random numbers using the permuted block&#xD;
      randomization method. The collected data are coded, processed, and analyzed using SPSS&#xD;
      program. All data are considered statistically significant if P value is ≤ 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Actual">July 21, 2020</completion_date>
  <primary_completion_date type="Actual">July 1, 2020</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of oculocardiac reflex</measure>
    <time_frame>Up to the end of the surgery</time_frame>
    <description>Any dysrhythmia or rapid reduction in HR by more than 25% from the baseline is taken as oculocardiac reflex.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in bispectral index</measure>
    <time_frame>Up to the end of the surgery</time_frame>
    <description>Bispectral index values (0-100) are recorded every five minutes until the end of the surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in heart rate</measure>
    <time_frame>Up to the end of the surgery</time_frame>
    <description>Heart rate (beat/min) is recorded at five-minute intervals until the end of the surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in mean arterial blood pressure</measure>
    <time_frame>Up to the end of the surgery</time_frame>
    <description>Mean blood pressure (mmHg) is recorded at five-minute intervals until the end of the surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in postoperative emergence agitation scale</measure>
    <time_frame>Up to 30 minutes after surgery</time_frame>
    <description>Agitation is assessed using the 5- step Cravero scale (1-5) every five minutes from awakening and for 30 minutes.(1:Obtunded with no response to stimulation, 2:Asleep but responsive to movement or stimulation, 3:Awake and responsive, 4:Crying, 5:Thrashing behaviour that requires restraint)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in postoperative pain score</measure>
    <time_frame>Up to 24 hours after surgery</time_frame>
    <description>Pain score from 0 to 10 (0 = no pain and 10 = the worst imaginable pain) is assessed every two hours for 24 hours after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>First analgesic request</measure>
    <time_frame>Up to 24 hours after surgery</time_frame>
    <description>The time of the first analgesic request for paracetamol is recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total analgesic requirements of paracetamol</measure>
    <time_frame>Up to 24 hours after surgery</time_frame>
    <description>The amount of paracetamol consumption given as a rescue analgesia to patients is measured all over the 24 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of postoperative nausea and vomiting</measure>
    <time_frame>Up to 24 hours after surgery</time_frame>
    <description>Incidence of postoperative nausea and vomiting is assessed during the first 24 hours post-operatively.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Strabismus</condition>
  <arm_group>
    <arm_group_label>Sevoflurane Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Laryngeal mask airway is inserted and anesthesia is maintained with sevoflurane anesthesia under BIS monitoring.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Propofol Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Laryngeal mask airway is inserted and anesthesia is maintained with propofol infusion under BIS monitoring.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bispectral Index Monitor</intervention_name>
    <description>Bispectral Index (BIS) sensor electrodes are applied over the patient's forehead after cleaning the forehead thoroughly with an alcohol swab.</description>
    <arm_group_label>Propofol Group</arm_group_label>
    <arm_group_label>Sevoflurane Group</arm_group_label>
    <other_name>BIS Monitoring</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laryngeal Mask Airway</intervention_name>
    <description>Capnography connected to laryngeal mask airway is introduced after adequate jaw relaxation and oral airway tolerance; its size is chosen according to the body weight of the child.</description>
    <arm_group_label>Propofol Group</arm_group_label>
    <arm_group_label>Sevoflurane Group</arm_group_label>
    <other_name>Supraglottic Airway Device</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevoflurane</intervention_name>
    <description>Anesthesia is induced inhalationally by face mask with 8% sevoflurane in 100% oxygen, then decreased to 2-3% in 40% oxygen thoroughout the operation for maintenance of anesthesia.</description>
    <arm_group_label>Sevoflurane Group</arm_group_label>
    <other_name>Inhalational Anesthesia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>Anesthesia is induced by propofol (2mg/kg), then maintained using an infusion of fixed concentration (10-15 mg/kg/h) as titrated by the anesthesiologist .</description>
    <arm_group_label>Propofol Group</arm_group_label>
    <other_name>Intravenous Anesthesia</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiology (ASA) I and II patients.&#xD;
&#xD;
          -  Scheduled for elective Strabismus surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parental refusal of consent.&#xD;
&#xD;
          -  Hyperactive airway disease or respiratory diseases.&#xD;
&#xD;
          -  Children with developmental delays, mental or neurological disorders.&#xD;
&#xD;
          -  Bleeding or coagulation diathesis.&#xD;
&#xD;
          -  History of known sensitivity to the used anesthetics.&#xD;
&#xD;
          -  Children with previous surgery in the eye.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sameh M El-Sherbiny, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mansoura Faculty of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anesthesia, Mansoura University Hospitals</name>
      <address>
        <city>Mansoura</city>
        <state>Dakahlia</state>
        <zip>35511</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>June 8, 2021</last_update_submitted>
  <last_update_submitted_qc>June 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Sameh Fathy</investigator_full_name>
    <investigator_title>Lecturer of anesthesia, ICU &amp; pain management; Faculty of Medicine</investigator_title>
  </responsible_party>
  <keyword>Bispectral Index Monitoring</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Strabismus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Sevoflurane</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04485117
org study id: BIS Monitoring in Strabismus
nct id: NCT04485117
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is conducted to evaluate importance of bispectral index (BIS) monitoring in
      patients undergoing strabismus surgery when using propofol in comparison to sevoflurane
      anesthesia regarding their effects on oculocardiac reflex, intraoperative hemodynamic
      stability, emergence agitation, postoperative pain, nausea and vomiting.
Strabismus surgery can cause unfavorable side effects during intraoperative and postoperative
      periods including increased risk of the oculocardiac reflex, hemodynamic instability,
      emergence agitation, postoperative pain, nausea and vomiting. Sevoflurane is an inhalation
      anesthetic widely used in pediatric anesthesia with minimal airway irritation. Propofol is an
      intravenous sedative-hypnotic agent with amnestic properties that causes loss of
      consciousness. Bispectral index monitor provide some more evidence that deeper anesthesia can
      provide some protection against the oculocardiac reflex. Therefore, this study is conducted
      to evaluate the role of BIS monitoring in comparing the use of propofol and sevoflurane
      anesthesia in pediatric strabismus surgery.

      This prospective, randomized, comparative clinical study will include 100 children who are
      scheduled for elective strabismus surgery under general anesthesia in Mansoura ophthalmology
      center. Informed written consent is obtained from parents of all subjects in the study after
      ensuring confidentiality. The study protocol is explained to parents of all patients in the
      study who are kept fasting prior to surgery. Patients are randomly assigned to two equal
      groups according to computer-generated table of random numbers using the permuted block
      randomization method. The collected data are coded, processed, and analyzed using SPSS
      program. All data are considered statistically significant if P value is ≤ 0.05.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Incidence of oculocardiac reflex
time frame: Up to the end of the surgery
description: Any dysrhythmia or rapid reduction in HR by more than 25% from the baseline is taken as oculocardiac reflex.
measure: Changes in bispectral index
time frame: Up to the end of the surgery
description: Bispectral index values (0-100) are recorded every five minutes until the end of the surgery
measure: Changes in heart rate
time frame: Up to the end of the surgery
description: Heart rate (beat/min) is recorded at five-minute intervals until the end of the surgery
measure: Changes in mean arterial blood pressure
time frame: Up to the end of the surgery
description: Mean blood pressure (mmHg) is recorded at five-minute intervals until the end of the surgery
measure: Changes in postoperative emergence agitation scale
time frame: Up to 30 minutes after surgery
description: Agitation is assessed using the 5- step Cravero scale (1-5) every five minutes from awakening and for 30 minutes.(1:Obtunded with no response to stimulation, 2:Asleep but responsive to movement or stimulation, 3:Awake and responsive, 4:Crying, 5:Thrashing behaviour that requires restraint)
measure: Changes in postoperative pain score
time frame: Up to 24 hours after surgery
description: Pain score from 0 to 10 (0 = no pain and 10 = the worst imaginable pain) is assessed every two hours for 24 hours after surgery.
measure: First analgesic request
time frame: Up to 24 hours after surgery
description: The time of the first analgesic request for paracetamol is recorded.
measure: Total analgesic requirements of paracetamol
time frame: Up to 24 hours after surgery
description: The amount of paracetamol consumption given as a rescue analgesia to patients is measured all over the 24 hours.
measure: Incidence of postoperative nausea and vomiting
time frame: Up to 24 hours after surgery
description: Incidence of postoperative nausea and vomiting is assessed during the first 24 hours post-operatively.
arm group label: Sevoflurane Group
arm group type: Active Comparator
description: Laryngeal mask airway is inserted and anesthesia is maintained with sevoflurane anesthesia under BIS monitoring.
arm group label: Propofol Group
arm group type: Active Comparator
description: Laryngeal mask airway is inserted and anesthesia is maintained with propofol infusion under BIS monitoring.
intervention type: Device
intervention name: Bispectral Index Monitor
description: Bispectral Index (BIS) sensor electrodes are applied over the patient's forehead after cleaning the forehead thoroughly with an alcohol swab.
arm group label: Propofol Group
arm group label: Sevoflurane Group
other name: BIS Monitoring
intervention type: Device
intervention name: Laryngeal Mask Airway
description: Capnography connected to laryngeal mask airway is introduced after adequate jaw relaxation and oral airway tolerance; its size is chosen according to the body weight of the child.
arm group label: Propofol Group
arm group label: Sevoflurane Group
other name: Supraglottic Airway Device
intervention type: Drug
intervention name: Sevoflurane
description: Anesthesia is induced inhalationally by face mask with 8% sevoflurane in 100% oxygen, then decreased to 2-3% in 40% oxygen thoroughout the operation for maintenance of anesthesia.
arm group label: Sevoflurane Group
other name: Inhalational Anesthesia
intervention type: Drug
intervention name: Propofol
description: Anesthesia is induced by propofol (2mg/kg), then maintained using an infusion of fixed concentration (10-15 mg/kg/h) as titrated by the anesthesiologist .
arm group label: Propofol Group
other name: Intravenous Anesthesia
criteria: 
gender: All
minimum age: 3 Years
maximum age: 8 Years
healthy volunteers: No
last name: Sameh M El-Sherbiny, MD
role: Principal Investigator
affiliation: Mansoura Faculty of Medicine
facility: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Mansoura University
investigator full name: Sameh Fathy
investigator title: Lecturer of anesthesia, ICU & pain management; Faculty of Medicine
mesh term: Strabismus
mesh term: Anesthetics
mesh term: Propofol
mesh term: Sevoflurane
sharing ipd: No