<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/NCT02193737</url>
  </required_header>
  <id_info>
    <org_study_id>I-DRINC</org_study_id>
    <nct_id>NCT02193737</nct_id>
  </id_info>
  <brief_title>Effects of Drinking at PACU Discharge After General Anaesthesia With Airway Control on Aspiration, Vomiting and Patients Comfort</brief_title>
  <acronym>I-DRINC</acronym>
  <official_title>Effects of Drinking at PACU Discharge After General Anaesthesia With Airway Control on Aspiration, Vomiting and Patients Comfort.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poitiers University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Poitiers University Hospital</source>
  <brief_summary>
    <textblock>
      National guidelines about post-operative fasting after general anesthesia are missing.&#xD;
&#xD;
      Current clinical practices are highly variable and no study has ever evaluated on a large&#xD;
      scale the real risk of an early drinks recovery in postoperative period.&#xD;
&#xD;
      The aim of this study is to state the impact of early drinks recovery after general&#xD;
      anesthesia with laryngeal mask or endotracheal intubation on the risk of aspiration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 13, 2014</start_date>
  <completion_date type="Actual">September 1, 2016</completion_date>
  <primary_completion_date type="Actual">September 1, 2016</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To determine if early oral fluid recovery after an elective surgery under general anaesthesia with endotracheal intubation or laryngeal mask increasethe incidence of cough during swallowing, ie aspiration.</measure>
    <time_frame>1min</time_frame>
    <description>During first swallowing, patients will be observed to establish if cough occurs during this first swallowing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To determine if early oral fluid recovery (i.e patient discharged of PACU) after general anaesthesia increases post-operative vomiting during first hour and patient comfort rated on a 10 points scale.</measure>
    <time_frame>1 hour</time_frame>
    <description>During a one-hour period after first swallowing, patients will be looked after for any vomiting.&#xD;
At the end of day, patients will be asked to rate their postoperative comfort on a 10 points scale.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1555</enrollment>
  <condition>Scheduled General Anaesthesia With Airway Control</condition>
  <arm_group>
    <arm_group_label>Early oral fluid recovery.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed oral fluid recovery.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Early oral fluid recovery.</intervention_name>
    <arm_group_label>Early oral fluid recovery.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Delayed oral fluid recovery.</intervention_name>
    <arm_group_label>Delayed oral fluid recovery.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Scheduled surgery&#xD;
&#xD;
          -  General anaesthesia with laryngeal mask or endotracheal intubation.&#xD;
&#xD;
          -  Length of surgery &lt; 4 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency surgery&#xD;
&#xD;
          -  Intra-cranial, cervical or Ear, Nose and Throat surgery&#xD;
&#xD;
          -  Guts surgery with guts anastomosis.&#xD;
&#xD;
          -  Glottic topical anesthesia&#xD;
&#xD;
          -  Patient with nasogastric tube&#xD;
&#xD;
          -  Aspiration during surgery or during PACU stay&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital of Poitiers</name>
      <address>
        <city>Poitiers</city>
        <state>Vienne</state>
        <zip>86000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>May 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>April 10, 2020</last_update_submitted>
  <last_update_submitted_qc>April 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT02193737
org study id: I-DRINC
nct id: NCT02193737
lead sponsor: 
National guidelines about post-operative fasting after general anesthesia are missing.

      Current clinical practices are highly variable and no study has ever evaluated on a large
      scale the real risk of an early drinks recovery in postoperative period.

      The aim of this study is to state the impact of early drinks recovery after general
      anesthesia with laryngeal mask or endotracheal intubation on the risk of aspiration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: To determine if early oral fluid recovery after an elective surgery under general anaesthesia with endotracheal intubation or laryngeal mask increasethe incidence of cough during swallowing, ie aspiration.
time frame: 1min
description: During first swallowing, patients will be observed to establish if cough occurs during this first swallowing.
measure: To determine if early oral fluid recovery (i.e patient discharged of PACU) after general anaesthesia increases post-operative vomiting during first hour and patient comfort rated on a 10 points scale.
time frame: 1 hour
description: During a one-hour period after first swallowing, patients will be looked after for any vomiting.
At the end of day, patients will be asked to rate their postoperative comfort on a 10 points scale.
arm group label: Early oral fluid recovery.
arm group type: Experimental
arm group label: Delayed oral fluid recovery.
arm group type: Active Comparator
intervention type: Procedure
intervention name: Early oral fluid recovery.
arm group label: Early oral fluid recovery.
intervention type: Procedure
intervention name: Delayed oral fluid recovery.
arm group label: Delayed oral fluid recovery.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
country: France
responsible party type: Sponsor
mesh term: Vomiting