<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/NCT04485273</url>
  </required_header>
  <id_info>
    <org_study_id>Dexmedetomedine and agitation</org_study_id>
    <nct_id>NCT04485273</nct_id>
  </id_info>
  <brief_title>Effect of Dexmedetomedine in Subtenon's Block on Emergence Agitation in Pediatric Strabismus Surgery</brief_title>
  <official_title>Effect of Dexmedetomedine in Subtenon's Block on Emergence Agitation in Pediatric Strabismus Surgery Under Sevoflurane Anesthesia</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>
      The study is conducted to evaluate the effects of dexmedetomedine in subtenon's block in&#xD;
      conjunction to general anesthesia under sevoflurane anesthesia on emergence agitation,&#xD;
      intraoperative hemodynamic stability, postoperative pain, nausea and vomiting in patients&#xD;
      undergoing strabismus surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Emergency agitation is a clinical status of postoperative excitement or emergence delirium&#xD;
      when the patient is awake but is disorientated. It is described as mental disturbances that&#xD;
      consist of confusion, hallucinations and delusions which is manifested by restless&#xD;
      involuntary physical activity and thrashing about the bed. Its incidence has been observed&#xD;
      especially in pediatric ophthalmology care units due to many factors such as pain, mental&#xD;
      status, time of operation, age, lack of ability to see outside, and a history of previous&#xD;
      hyperthermia. Strabismus surgery is one of the most frequently performed pediatric ocular&#xD;
      operations. However, it can cause unfavorable side effects during intraoperative and&#xD;
      postoperative periods. Typically, the major problems associated with strabismus surgeries&#xD;
      include increased risk of the oculocardiac reflex, postoperative pain, nausea and vomiting.&#xD;
      Subtenon's block is one of the regional anesthetic techniques used in ocular surgery.&#xD;
      Dexmedetomidine has been used as an adjuvant to local anesthetics for regional anesthesia in&#xD;
      various clinical fields including the subtenon's block.There is evidence that dexmedetomidine&#xD;
      decreases the incidence of agitation after sevoflurane anesthesia in children undergoing&#xD;
      different surgical procedures. Therefore, this study is conducted to evaluate the effect of&#xD;
      dexmedetomedine in subtenon's block on emergence agitation in pediatric strabismus surgery&#xD;
      under sevoflurane anesthesia.&#xD;
&#xD;
      This prospective, randomized, clinical study includes 100 children who are scheduled for&#xD;
      elective strabismus surgery under general surgery in Mansoura ophthalmology center. Informed&#xD;
      written consent is obtained from parents of all subjects in the study after ensuring&#xD;
      confidentiality.The study protocol is explained to parents of all patients in the study who&#xD;
      are kept fasting prior to surgery. Patients are randomly assigned to two equal groups&#xD;
      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">July 1, 2019</start_date>
  <completion_date type="Actual">December 1, 2021</completion_date>
  <primary_completion_date type="Actual">January 1, 2021</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>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>
  </primary_outcome>
  <primary_outcome>
    <measure>Emergence time</measure>
    <time_frame>Up to 30 minutes after surgery</time_frame>
    <description>Emergence time (min) is recorded; from the discontinuation of sevoflurane to the first response on verbal command.</description>
  </primary_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>Blood pressure (mmHg) is recorded at five-minute intervals until the end of the surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of oculocardiac reflex</measure>
    <time_frame>Up to the end of the surgery</time_frame>
    <description>If there is dysrhythmia or rapid reduction in HR by more than 25% from the baseline, it is considered as an oculocardiac reflex.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in pain scores</measure>
    <time_frame>Up to 24 hours after the procedure</time_frame>
    <description>Pain score from 0 to 10 (0 = no pain and 10 = the worst imaginable pain) is assessed every two hours up to 24 hours after the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total analgesic requirements of paracetamol</measure>
    <time_frame>Up to 24 hours after the procedure</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>First analgesic request</measure>
    <time_frame>Up to 24 hours after the procedure</time_frame>
    <description>The time of the first analgesic request for paracetamol is recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of postoperative nausea and vomiting</measure>
    <time_frame>Up to 24 hours after the procedure</time_frame>
    <description>Incidence of postoperative nausea and vomiting is assessed up to 24 hours after the procedure.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Emergence Agitation</condition>
  <arm_group>
    <arm_group_label>Dexmedetomedine Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Laryngeal mask airway is inserted and anesthesia is maintained with sevoflurane. Subtenon's block is performed and local anesthetic solution is injected, in addition to dexmedetomedine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Laryngeal mask airway is inserted and anesthesia is maintained with sevoflurane. Subtenon's block is performed and local anesthetic solution is injected.</description>
  </arm_group>
  <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>Control Group</arm_group_label>
    <arm_group_label>Dexmedetomedine Group</arm_group_label>
    <other_name>Supraglottic Airway Device</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevoflurane</intervention_name>
    <description>Sevoflurane in air/oxygen mixture of 40% is titrated to achieve adequate depth of anesthesia.</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Dexmedetomedine Group</arm_group_label>
    <other_name>Inhalational Anesthesia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Subtenon's Block</intervention_name>
    <description>Subtenon's block is performed in the eye undergoing surgery under sterile conditions where a 19-gauge curved blunt metallic cannula (25 mm) is inserted into sub-tenon's space.</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Dexmedetomedine Group</arm_group_label>
    <other_name>Regional Eye Block</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Local Anesthetic Solution and Dexmedetomedine</intervention_name>
    <description>The local anesthetic solution is injected with a dose of 0.5% bupivacaine (0.08 ml/kg), in addition to dexmedetomedine (0.5 μg /kg)</description>
    <arm_group_label>Dexmedetomedine Group</arm_group_label>
    <other_name>Marcaine and Precedex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Local Anesthetic Solution</intervention_name>
    <description>The local anesthetic solution is injected with a dose of 0.5% bupivacaine (0.08 ml/kg).</description>
    <arm_group_label>Control Group</arm_group_label>
    <other_name>Marcaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiology (ASA) I and II patients.&#xD;
&#xD;
          -  Scheduled for strabismus surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parental refusal of consent.&#xD;
&#xD;
          -  Contraindication to use of supraglottic airway device as gastroesophageal reflux and&#xD;
             oropharyngeal pathology.&#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;
          -  Previous surgery in the same eye&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 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 2022</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 18, 2022</last_update_submitted>
  <last_update_submitted_qc>June 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2022</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>Dexmedetomedine</keyword>
  <keyword>Subtenon's Block</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psychomotor Agitation</mesh_term>
    <mesh_term>Strabismus</mesh_term>
    <mesh_term>Emergence Delirium</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
    <mesh_term>Sevoflurane</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
    <mesh_term>Anesthetics, Local</mesh_term>
    <mesh_term>Pharmaceutical Solutions</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/NCT04485273
org study id: Dexmedetomedine and agitation
nct id: NCT04485273
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study is conducted to evaluate the effects of dexmedetomedine in subtenon's block in
      conjunction to general anesthesia under sevoflurane anesthesia on emergence agitation,
      intraoperative hemodynamic stability, postoperative pain, nausea and vomiting in patients
      undergoing strabismus surgery.
Emergency agitation is a clinical status of postoperative excitement or emergence delirium
      when the patient is awake but is disorientated. It is described as mental disturbances that
      consist of confusion, hallucinations and delusions which is manifested by restless
      involuntary physical activity and thrashing about the bed. Its incidence has been observed
      especially in pediatric ophthalmology care units due to many factors such as pain, mental
      status, time of operation, age, lack of ability to see outside, and a history of previous
      hyperthermia. Strabismus surgery is one of the most frequently performed pediatric ocular
      operations. However, it can cause unfavorable side effects during intraoperative and
      postoperative periods. Typically, the major problems associated with strabismus surgeries
      include increased risk of the oculocardiac reflex, postoperative pain, nausea and vomiting.
      Subtenon's block is one of the regional anesthetic techniques used in ocular surgery.
      Dexmedetomidine has been used as an adjuvant to local anesthetics for regional anesthesia in
      various clinical fields including the subtenon's block.There is evidence that dexmedetomidine
      decreases the incidence of agitation after sevoflurane anesthesia in children undergoing
      different surgical procedures. Therefore, this study is conducted to evaluate the effect of
      dexmedetomedine in subtenon's block on emergence agitation in pediatric strabismus surgery
      under sevoflurane anesthesia.

      This prospective, randomized, clinical study includes 100 children who are scheduled for
      elective strabismus surgery under general surgery 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: 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: Emergence time
time frame: Up to 30 minutes after surgery
description: Emergence time (min) is recorded; from the discontinuation of sevoflurane to the first response on verbal command.
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: Blood pressure (mmHg) is recorded at five-minute intervals until the end of the surgery.
measure: Incidence of oculocardiac reflex
time frame: Up to the end of the surgery
description: If there is dysrhythmia or rapid reduction in HR by more than 25% from the baseline, it is considered as an oculocardiac reflex.
measure: Changes in pain scores
time frame: Up to 24 hours after the procedure
description: Pain score from 0 to 10 (0 = no pain and 10 = the worst imaginable pain) is assessed every two hours up to 24 hours after the procedure.
measure: Total analgesic requirements of paracetamol
time frame: Up to 24 hours after the procedure
description: The amount of paracetamol consumption given as a rescue analgesia to patients is measured all over the 24 hours.
measure: First analgesic request
time frame: Up to 24 hours after the procedure
description: The time of the first analgesic request for paracetamol is recorded.
measure: Incidence of postoperative nausea and vomiting
time frame: Up to 24 hours after the procedure
description: Incidence of postoperative nausea and vomiting is assessed up to 24 hours after the procedure.
arm group label: Dexmedetomedine Group
arm group type: Active Comparator
description: Laryngeal mask airway is inserted and anesthesia is maintained with sevoflurane. Subtenon's block is performed and local anesthetic solution is injected, in addition to dexmedetomedine.
arm group label: Control Group
arm group type: Placebo Comparator
description: Laryngeal mask airway is inserted and anesthesia is maintained with sevoflurane. Subtenon's block is performed and local anesthetic solution is injected.
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: Control Group
arm group label: Dexmedetomedine Group
other name: Supraglottic Airway Device
intervention type: Drug
intervention name: Sevoflurane
description: Sevoflurane in air/oxygen mixture of 40% is titrated to achieve adequate depth of anesthesia.
arm group label: Control Group
arm group label: Dexmedetomedine Group
other name: Inhalational Anesthesia
intervention type: Procedure
intervention name: Subtenon's Block
description: Subtenon's block is performed in the eye undergoing surgery under sterile conditions where a 19-gauge curved blunt metallic cannula (25 mm) is inserted into sub-tenon's space.
arm group label: Control Group
arm group label: Dexmedetomedine Group
other name: Regional Eye Block
intervention type: Drug
intervention name: Local Anesthetic Solution and Dexmedetomedine
description: The local anesthetic solution is injected with a dose of 0.5% bupivacaine (0.08 ml/kg), in addition to dexmedetomedine (0.5 μg /kg)
arm group label: Dexmedetomedine Group
other name: Marcaine and Precedex
intervention type: Drug
intervention name: Local Anesthetic Solution
description: The local anesthetic solution is injected with a dose of 0.5% bupivacaine (0.08 ml/kg).
arm group label: Control Group
other name: Marcaine
criteria: 
gender: All
minimum age: 2 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: Psychomotor Agitation
mesh term: Strabismus
mesh term: Emergence Delirium
mesh term: Anesthetics
mesh term: Sevoflurane
mesh term: Bupivacaine
mesh term: Anesthetics, Local
mesh term: Pharmaceutical Solutions
sharing ipd: No