<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/NCT03789942</url>
  </required_header>
  <id_info>
    <org_study_id>ÉTICA-ULE-011-2016</org_study_id>
    <nct_id>NCT03789942</nct_id>
  </id_info>
  <brief_title>Modification of Blood Pressure Levels and Oxygen Saturation in Patients Undergoing Conscious Sedation</brief_title>
  <official_title>Comparative Clinical Study of Cardiac and Respiratory Modifications Produced in Patients Undergoing Oral Surgery Through Local Anesthesia, Local Anesthesia and Oral Sedation With Midazolam, and Local Anesthesia Associated to Nitrous Oxide.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinica Luis Ortiz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinica Luis Ortiz</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective is to compare the changes produced in cardiological and respiratory parameters&#xD;
      in three groups of patients undergoing oral surgery. The first group was treated with local&#xD;
      anesthesia, a second group with local anesthesia plus oral conscious sedation with midazolam,&#xD;
      and a third subject under anesthesia local with inhalation sedation with nitrous oxide.&#xD;
&#xD;
      A total of 90 non-cooperative phobic adult patients belonging to the group of patients of the&#xD;
      University Master in Oral Surgery, Implantology and Periodontics of the University of León&#xD;
      will be included in this study, after their information and acceptance of verbal and written&#xD;
      consent, separated into three groups without significant differences in age, sex, smoking&#xD;
      habits, cardiac or respiratory pathologies, and will be treated by advanced procedures of&#xD;
      Oral Surgery, Periodontics and Implantology such as Sinus lift, Periodontal Surgeries and&#xD;
      Implant Surgeries.&#xD;
&#xD;
      They will be randomly divided into three groups of 30 patients each. They will be given a&#xD;
      prior consent both of the procedures to be performed and of the sedation procedure to which&#xD;
      they will be subjected, if that is the case, without knowing what dose they will be&#xD;
      administered. In case of being sedated, they will be informed verbally of the details&#xD;
      concerning the procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 90 non-cooperative phobic adult patients will be included in this study, after&#xD;
      their information and acceptance of verbal and written consent, separated into three groups&#xD;
      without significant differences in age, sex, smoking habits, cardiac or respiratory&#xD;
      pathologies, and will be treated by advanced procedures of Oral Surgery, Periodontics and&#xD;
      Implantology such as Sinus lift, Periodontal Surgeries and Implant Surgeries.&#xD;
&#xD;
      Initially, a complete health questionnaire will be filled out in all patients, and Partial&#xD;
      Oxygen Saturation (SpO2), Respiratory Rate, Respiratory Volume in the form of Forced Vital&#xD;
      Capacity (FVC), and also Forced Expiration Volume will be recorded as respiratory records&#xD;
      (FEV) and Maximum Expiratory Flow (PEF), and as cardiac registers the Heart Rate, and the&#xD;
      Systolic and Diastolic Blood Pressure before starting the procedure, records that will be&#xD;
      repeated every 5 minutes during and until the end of it. The parameters will be recorded&#xD;
      every 5 minutes, except for the parameters VFC, FEV1 and PEF that will be recorded&#xD;
      exclusively at the beginning and at the end of the procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2019</start_date>
  <completion_date type="Actual">March 30, 2019</completion_date>
  <primary_completion_date type="Actual">March 20, 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>90 patients will be randomly divided into three groups of 30 patients each. They will be given a prior consent both of the procedures to be performed and of the sedation procedure to which they will be subjected, if that is the case, without knowing what dose they will be administered. In case of being sedated, they will be informed verbally of the details concerning the procedure.&#xD;
Group 1, 30 patients treated by Oral Surgery procedures exclusively with Local Anesthesia.&#xD;
Group 2, 30 patients treated by procedures of Oral Surgery with Local Anesthesia and Oral Sedation with Midazolam.&#xD;
Group 3, 30 patients treated by Oral Surgery procedures with Local Anesthesia and Inhalation Sedation with a mixture of Nitrous Oxide / Oxygen.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Partial Oxygen Saturation (SpO2) change</measure>
    <time_frame>From the beginning of the sedation until the end, assessed Up to one hour</time_frame>
    <description>Partial Oxygen Saturation (SpO2) change</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory Rate change</measure>
    <time_frame>From the beginning of the sedation until the end, assessed Up to one hour</time_frame>
    <description>Respiratory Rate change</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forced Vital Capacity (FVC) change</measure>
    <time_frame>From the beginning of the sedation until the end, assessed Up to one hour</time_frame>
    <description>Forced Vital Capacity (FVC) change</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forced Expiration Volume (FEV) change</measure>
    <time_frame>From the beginning of the sedation until the end, assessed Up to one hour</time_frame>
    <description>Forced Expiration Volume (FEV) change</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Expiratory Flow (PEF) change</measure>
    <time_frame>From the beginning of the sedation until the end, assessed Up to one hour</time_frame>
    <description>Maximum Expiratory Flow (PEF) change</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart Rate change</measure>
    <time_frame>From the beginning of the sedation until the end, assessed Up to one hour</time_frame>
    <description>Heart Rate change</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diastolic Blood Pressure change</measure>
    <time_frame>From the beginning of the sedation until the end, assessed Up to one hour</time_frame>
    <description>Diastolic Blood Pressure change</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systolic blood pressure change</measure>
    <time_frame>From the beginning of the sedation until the end, assessed Up to one hour</time_frame>
    <description>Systolic blood pressure change</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Dental Anxiety</condition>
  <arm_group>
    <arm_group_label>1. Local anaesthesia for oral surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administration of local anesthesia, 40mg.epinephrine once. Oral surgery procedures Suturing End of procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2. Local anesthesia with Midazolam</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administration of 40mg. epinephrine once, and Oral Sedation with Midazolam 0,5 mgr per kilo once.&#xD;
Oral surgery procedures Suturing End of procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3. Local anesthesia and sedation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administration of 40mg. epinephrine once, and Inhalation Sedation by Nitrous Oxide / Oxygen.&#xD;
Nitrous oxide sedation Oral surgery procedures Suturing End of procedure Reduce nitrous oxide concentration</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Oral surgery</intervention_name>
    <description>Oral surgery procedures</description>
    <arm_group_label>1. Local anaesthesia for oral surgery</arm_group_label>
    <arm_group_label>2. Local anesthesia with Midazolam</arm_group_label>
    <arm_group_label>3. Local anesthesia and sedation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical Diagnosis of phobic patients&#xD;
&#xD;
          -  Not having contraindications to be anesthetized or sedated, and&#xD;
&#xD;
          -  Present an acceptable state of health (ASA I and ASA II).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical conditions; ASA III, ASA IV and ASA V&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ORTIZ CAMARERO</last_name>
    <role>Principal Investigator</role>
    <affiliation>ASISTANT PROFESSOR</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinica Luis Ortiz</name>
      <address>
        <city>Burgos</city>
        <zip>09003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>July 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>March 30, 2019</last_update_submitted>
  <last_update_submitted_qc>March 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <pending_results>
    <submitted>April 7, 2019</submitted>
    <returned>June 28, 2019</returned>
  </pending_results>
  <!-- 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/NCT03789942
org study id: ÉTICA-ULE-011-2016
nct id: NCT03789942
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The objective is to compare the changes produced in cardiological and respiratory parameters
      in three groups of patients undergoing oral surgery. The first group was treated with local
      anesthesia, a second group with local anesthesia plus oral conscious sedation with midazolam,
      and a third subject under anesthesia local with inhalation sedation with nitrous oxide.

      A total of 90 non-cooperative phobic adult patients belonging to the group of patients of the
      University Master in Oral Surgery, Implantology and Periodontics of the University of León
      will be included in this study, after their information and acceptance of verbal and written
      consent, separated into three groups without significant differences in age, sex, smoking
      habits, cardiac or respiratory pathologies, and will be treated by advanced procedures of
      Oral Surgery, Periodontics and Implantology such as Sinus lift, Periodontal Surgeries and
      Implant Surgeries.

      They will be randomly divided into three groups of 30 patients each. They will be given a
      prior consent both of the procedures to be performed and of the sedation procedure to which
      they will be subjected, if that is the case, without knowing what dose they will be
      administered. In case of being sedated, they will be informed verbally of the details
      concerning the procedure.
A total of 90 non-cooperative phobic adult patients will be included in this study, after
      their information and acceptance of verbal and written consent, separated into three groups
      without significant differences in age, sex, smoking habits, cardiac or respiratory
      pathologies, and will be treated by advanced procedures of Oral Surgery, Periodontics and
      Implantology such as Sinus lift, Periodontal Surgeries and Implant Surgeries.

      Initially, a complete health questionnaire will be filled out in all patients, and Partial
      Oxygen Saturation (SpO2), Respiratory Rate, Respiratory Volume in the form of Forced Vital
      Capacity (FVC), and also Forced Expiration Volume will be recorded as respiratory records
      (FEV) and Maximum Expiratory Flow (PEF), and as cardiac registers the Heart Rate, and the
      Systolic and Diastolic Blood Pressure before starting the procedure, records that will be
      repeated every 5 minutes during and until the end of it. The parameters will be recorded
      every 5 minutes, except for the parameters VFC, FEV1 and PEF that will be recorded
      exclusively at the beginning and at the end of the procedure.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 90 patients will be randomly divided into three groups of 30 patients each. They will be given a prior consent both of the procedures to be performed and of the sedation procedure to which they will be subjected, if that is the case, without knowing what dose they will be administered. In case of being sedated, they will be informed verbally of the details concerning the procedure.
Group 1, 30 patients treated by Oral Surgery procedures exclusively with Local Anesthesia.
Group 2, 30 patients treated by procedures of Oral Surgery with Local Anesthesia and Oral Sedation with Midazolam.
Group 3, 30 patients treated by Oral Surgery procedures with Local Anesthesia and Inhalation Sedation with a mixture of Nitrous Oxide / Oxygen.
primary purpose: Treatment
masking: None (Open Label)
measure: Partial Oxygen Saturation (SpO2) change
time frame: From the beginning of the sedation until the end, assessed Up to one hour
description: Partial Oxygen Saturation (SpO2) change
measure: Respiratory Rate change
time frame: From the beginning of the sedation until the end, assessed Up to one hour
description: Respiratory Rate change
measure: Forced Vital Capacity (FVC) change
time frame: From the beginning of the sedation until the end, assessed Up to one hour
description: Forced Vital Capacity (FVC) change
measure: Forced Expiration Volume (FEV) change
time frame: From the beginning of the sedation until the end, assessed Up to one hour
description: Forced Expiration Volume (FEV) change
measure: Maximum Expiratory Flow (PEF) change
time frame: From the beginning of the sedation until the end, assessed Up to one hour
description: Maximum Expiratory Flow (PEF) change
measure: Heart Rate change
time frame: From the beginning of the sedation until the end, assessed Up to one hour
description: Heart Rate change
measure: Diastolic Blood Pressure change
time frame: From the beginning of the sedation until the end, assessed Up to one hour
description: Diastolic Blood Pressure change
measure: Systolic blood pressure change
time frame: From the beginning of the sedation until the end, assessed Up to one hour
description: Systolic blood pressure change
arm group label: 1. Local anaesthesia for oral surgery
arm group type: Active Comparator
description: Administration of local anesthesia, 40mg.epinephrine once. Oral surgery procedures Suturing End of procedure
arm group label: 2. Local anesthesia with Midazolam
arm group type: Active Comparator
description: Administration of 40mg. epinephrine once, and Oral Sedation with Midazolam 0,5 mgr per kilo once.
Oral surgery procedures Suturing End of procedure
arm group label: 3. Local anesthesia and sedation
arm group type: Active Comparator
description: Administration of 40mg. epinephrine once, and Inhalation Sedation by Nitrous Oxide / Oxygen.
Nitrous oxide sedation Oral surgery procedures Suturing End of procedure Reduce nitrous oxide concentration
intervention type: Procedure
intervention name: Oral surgery
description: Oral surgery procedures
arm group label: 1. Local anaesthesia for oral surgery
arm group label: 2. Local anesthesia with Midazolam
arm group label: 3. Local anesthesia and sedation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: ORTIZ CAMARERO
role: Principal Investigator
affiliation: ASISTANT PROFESSOR
facility: 
country: Spain
responsible party type: Sponsor
submitted: April 7, 2019
returned: June 28, 2019