<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/NCT03806400</url>
  </required_header>
  <id_info>
    <org_study_id>2018-204</org_study_id>
    <nct_id>NCT03806400</nct_id>
  </id_info>
  <brief_title>Postoperative Nausea and Vomit in Strabismus Surgery</brief_title>
  <acronym>PONVISS</acronym>
  <official_title>Postoperative Nausea and Vomiting After Paediatric Strabismus Surgery: a Study of Perioperative Modifiable Risk Factors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Postoperative nausea and vomiting (PONV) is a major concern in paediatric inpatient surgery&#xD;
      and may increase patient discomfort, delay patient discharge, and increase the cost of&#xD;
      patient care. The incidence of PONV after strabismus surgery is relatively high, compared&#xD;
      with other inpatient surgeries, particularly in children. Oculocardiac reflex (OCR) is a&#xD;
      phenomenon defined by bradycardia or dysrhythmia during strabismus surgery. Oculocardiac&#xD;
      reflex is commonly caused by the traction on the extraocular muscle (EOM), which, through the&#xD;
      ophthalmic branch of trigeminal nerve, stimulates the vagal center. The afferent arm of the&#xD;
      reflex is the ophthalmic branch of the trigeminal nerve, and the efferent arm is the vagus&#xD;
      nerve, which diminishes sinoatrial node impulses and leads to bradycardia.While there is a&#xD;
      general consensus regarding the role of unmodifiable risk factors for PONV, including the&#xD;
      number of muscle and the occurrence of Oculocardiac reflex or not, the role of modifiable&#xD;
      risk factors, such as duration of surgery and anesthesia and perioperatively administered&#xD;
      medications, is still disputed. In the present study, the investigators evaluated whether&#xD;
      these factors may be associated with postoperative nausea and vomiting after paediatric&#xD;
      strabismus surgery while controlling for a range of covariates.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary outcome was incidence of PONV that occurred within 3 days after the operation.&#xD;
      The investigators defined PONV as a presence of either nausea or vomiting. In study hospital,&#xD;
      it was routine for nurses to assess and record nausea and vomiting every 8 hours for all&#xD;
      postoperative patients during postoperative 3 days. Accordingly, the investigators&#xD;
      retrospectively collected the presence of PONV from electrical medical records. If patients&#xD;
      had discharged hospital within postoperative 3 days, the incidence of PONV was assessed&#xD;
      solely during hospital stay. The data, collected included information regarding age at&#xD;
      surgery, gender, and type of strabismus. During strabismus surgery, the number and sequence&#xD;
      of the operated muscles, HR before traction of the EOM (baseline HR), maximum decreased HR&#xD;
      after traction of the EOM, HR at maximum recovery from decreased HR and maintained during&#xD;
      traction of the EOM (adrenergic HR), and HR at the cutting of the muscle, were collected.&#xD;
      Oculocardiac reflex was defined as a decrease in HR greater than or equal to 20% rather than&#xD;
      maximum at first traction of the muscle.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 27, 2018</start_date>
  <completion_date type="Actual">September 20, 2020</completion_date>
  <primary_completion_date type="Actual">May 20, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative nausea and vomiting</measure>
    <time_frame>Day 3 postoperative</time_frame>
    <description>Rate of postoperative nausea and vomiting</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>oculocardiac reflex</measure>
    <time_frame>through study completion, an average of 1 hour</time_frame>
    <description>Rate of oculocardiac reflex</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with operated muscle</measure>
    <time_frame>through study completion, an average of 1 hour</time_frame>
    <description>Number of Participants with strabismus surgery</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Duration of surgery and anesthesia</measure>
    <time_frame>through study completion, an average of 1 hour</time_frame>
    <description>Duration of surgery and anesthesia</description>
  </other_outcome>
  <enrollment type="Actual">300</enrollment>
  <condition>Strabismus</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients aged from 2-14 years who underwent strabismus surgery under general anesthesia&#xD;
        between January 2018 and November 2018 were included in this study. -&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:All patients aged from 2-14 years who underwent strabismus surgery under&#xD;
        general anesthesia between January 2018 and November 2018 were included in this study. -&#xD;
&#xD;
        Exclusion Criteria:patients with American Society of Anesthesiologists (ASA) physical&#xD;
        status III or higher. -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhiying Wu, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>Second Affiliated Hospital, School of Medicine, Zhejiang University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Second Affiliated Hospital, Zhejiang University School of Medicine</name>
      <address>
        <city>Hanzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>December 16, 2020</last_update_submitted>
  <last_update_submitted_qc>December 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Postoperative nausea and vomiting</keyword>
  <keyword>strabismus surgery</keyword>
  <keyword>oculocardiac reflex</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Strabismus</mesh_term>
    <mesh_term>Nausea</mesh_term>
    <mesh_term>Postoperative Nausea and Vomiting</mesh_term>
  </condition_browse>
  <!-- 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/NCT03806400
org study id: 2018-204
nct id: NCT03806400
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Postoperative nausea and vomiting (PONV) is a major concern in paediatric inpatient surgery
      and may increase patient discomfort, delay patient discharge, and increase the cost of
      patient care. The incidence of PONV after strabismus surgery is relatively high, compared
      with other inpatient surgeries, particularly in children. Oculocardiac reflex (OCR) is a
      phenomenon defined by bradycardia or dysrhythmia during strabismus surgery. Oculocardiac
      reflex is commonly caused by the traction on the extraocular muscle (EOM), which, through the
      ophthalmic branch of trigeminal nerve, stimulates the vagal center. The afferent arm of the
      reflex is the ophthalmic branch of the trigeminal nerve, and the efferent arm is the vagus
      nerve, which diminishes sinoatrial node impulses and leads to bradycardia.While there is a
      general consensus regarding the role of unmodifiable risk factors for PONV, including the
      number of muscle and the occurrence of Oculocardiac reflex or not, the role of modifiable
      risk factors, such as duration of surgery and anesthesia and perioperatively administered
      medications, is still disputed. In the present study, the investigators evaluated whether
      these factors may be associated with postoperative nausea and vomiting after paediatric
      strabismus surgery while controlling for a range of covariates.
The primary outcome was incidence of PONV that occurred within 3 days after the operation.
      The investigators defined PONV as a presence of either nausea or vomiting. In study hospital,
      it was routine for nurses to assess and record nausea and vomiting every 8 hours for all
      postoperative patients during postoperative 3 days. Accordingly, the investigators
      retrospectively collected the presence of PONV from electrical medical records. If patients
      had discharged hospital within postoperative 3 days, the incidence of PONV was assessed
      solely during hospital stay. The data, collected included information regarding age at
      surgery, gender, and type of strabismus. During strabismus surgery, the number and sequence
      of the operated muscles, HR before traction of the EOM (baseline HR), maximum decreased HR
      after traction of the EOM, HR at maximum recovery from decreased HR and maintained during
      traction of the EOM (adrenergic HR), and HR at the cutting of the muscle, were collected.
      Oculocardiac reflex was defined as a decrease in HR greater than or equal to 20% rather than
      maximum at first traction of the muscle.
observational model: Cohort
time perspective: Retrospective
measure: Postoperative nausea and vomiting
time frame: Day 3 postoperative
description: Rate of postoperative nausea and vomiting
measure: oculocardiac reflex
time frame: through study completion, an average of 1 hour
description: Rate of oculocardiac reflex
measure: Number of Participants with operated muscle
time frame: through study completion, an average of 1 hour
description: Number of Participants with strabismus surgery
measure: Duration of surgery and anesthesia
time frame: through study completion, an average of 1 hour
description: Duration of surgery and anesthesia
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 14 Years
healthy volunteers: No
last name: Zhiying Wu, Doctor
role: Study Chair
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
facility: 
country: China
responsible party type: Sponsor
mesh term: Strabismus
mesh term: Nausea
mesh term: Postoperative Nausea and Vomiting