<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/NCT03824470</url>
  </required_header>
  <id_info>
    <org_study_id>stop bang</org_study_id>
    <nct_id>NCT03824470</nct_id>
  </id_info>
  <brief_title>The Effect of Intubation Without Muscle Relaxation on Post Operative Recovery Conditions: Double Blind Randomized Controlled Study</brief_title>
  <official_title>The Effect of Non-Muscle Intubation on Post Operative Recovery Conditions in Patients With Obstructive Sleep Apnea Syndrome: Double Blind Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yuzuncu Yıl University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yuzuncu Yıl University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim of this study is to research the effect of intubation without muscle relaxant&#xD;
      on post-operative recovery conditions in patients with OSAS (obstructive sleep apnea&#xD;
      syndrome). Our secondary aim is to research the hemodynamic parameters in intraoperative&#xD;
      period and complications such as sore throat and laryngospasm voice limitation in the&#xD;
      postoperative period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Protocol, Methods and Procedures to be Applied:&#xD;
&#xD;
      This study will be carried out as double blinded randomized controlled after the approval of&#xD;
      the ethics committee of our hospital. By carrying out the Stop Bang questionnaire which is a&#xD;
      practical and highly sensitive test, 60 patients ranging from 18 to 65 years with a stop bang&#xD;
      score of 3 and ASA I-II and mallampati I and II scores will be included to the study. The&#xD;
      patients included in the study will be divided into two groups of 30 people randomly with a&#xD;
      closed envelope method. Patients who were intubated in the intensive care unit during&#xD;
      postoperative period, those using CPAP device at home or those who received OSAS therapy, who&#xD;
      had undergone head and neck surgery or who had head surgery, central nervous system damage&#xD;
      and cardiovascular or pulmonary stability, neuromuscular disease patients, those with known&#xD;
      allergies to the anesthetic agents used, those whose written and verbal consent cannot be&#xD;
      obtained, smokers, pregnants and patients with ASA III and IV will not be included in our&#xD;
      study. All patients will be seen a day in advance and after performing stop bang test, those&#xD;
      with test score of 3 and above will be included in the study and their physical examinations&#xD;
      and laboratory findings will be evaluated. The demographic data of the patients will be&#xD;
      recorded. The physician performing the anesthesia and the evaluating physician will be&#xD;
      different people. The evaluating physician will not know which anesthetic agent is used to&#xD;
      the patients. The group to be performed Esmeron will be named Group E and the group to be&#xD;
      given Remifentanil will be named Group R. All patients included in the study will be taken to&#xD;
      the operation room and the hemodynamic parameters (heart rate, mean blood pressure values,&#xD;
      SpO2) will be recorded by naninvasive monitoring. The data obtained will be considered as&#xD;
      basal. All patients will be given 2 mg / kg demisolam for the purpose of sedation. General&#xD;
      anesthesia will be done by connecting the Tof device to the patients. Anesthesia induction&#xD;
      will be done to anesthesia induction Group R with 1 mg / kg lidocaine, 4 mcg / kg&#xD;
      remifentanil and 2 mg / kg propofol intravenously. In group E, after the administration of 1&#xD;
      mg / kg lidocaine, 2 mg / kg propofol, 1 mcg / kg remifentanil and 0.6 mg / kg rocuronium,&#xD;
      patients in both groups will be intubated and general anesthesia will be performed when the&#xD;
      Tof value is 0. During intubation; intubation difficulty will be evaluated and recorded by&#xD;
      intubation scoring system. Anesthesia maintenance in both groups will be provided with 8%&#xD;
      desflurane, 40% O2, 60% dry air and iv. 0.025 mcg / kg / min remifentanil fusion. During the&#xD;
      study, the recorded basal hemodynamic parameters of the patients will be recorded in the&#xD;
      first 20 minutes of the operation with a 5-minute interval and 10-minute interval after the&#xD;
      20th minute. In case of a change of 20% in any one according to basal, it will be intervened&#xD;
      immediately. In order to provide the depth of anesthesia before the operation, patients will&#xD;
      be monitored with TOF device and the depth of anesthesia will be provided. Shortly after the&#xD;
      end of the surgery, the gases will be cut off and the Tof value of 70% and above will be&#xD;
      recorded. When Tof is 70%, Group R will be given 10 cc physiological saline intravenously. In&#xD;
      order to antagonize the muscle relaxant effect in Group E, 2 / mg / kg sguamadex will be&#xD;
      administered intravenously by diluting with 10 cc physiological saline. Patients will be&#xD;
      extubated when the tof value of both groups is 90%. The durations from 70% to 90% of the Tof&#xD;
      value, spontaneous eye opening duration after the patient is extubated, duration of&#xD;
      extubation, response duration to commands, duration until modified aldrete score is 10,&#xD;
      surgeon satisfaction (good, bad, moderate) and duration of surgery will be recorded. The&#xD;
      operation will be terminated by recording whether there is a need for ventilation with sore&#xD;
      throat, laryngospasm volume restriction, desaturation and mask.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 5, 2019</start_date>
  <completion_date type="Anticipated">March 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 15, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Post Operative Recovery</measure>
    <time_frame>1 hour</time_frame>
    <description>The durations from 70% to 90% of the Tof value, spontaneous eye opening duration after the patient is extubated, duration of extubation, response duration to commands, duration until modified aldrete score is 10</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Obstructive Sleep Apnea Syndrome</condition>
  <arm_group>
    <arm_group_label>Group E(rocuronium)</arm_group_label>
    <description>E, after the administration of 1 mg / kg lidocaine, 2 mg / kg propofol, 1 mcg / kg remifentanil and 0.6 mg / kg rocuronium intravenously, patients will be intubated and general anesthesia will be performed when the Tof value is 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group R (remifentanil)</arm_group_label>
    <description>1 mg / kg lidocaine, 4 mcg / kg remifentanil and 2 mg / kg propofol intravenously.patients will be intubated and general anesthesia will be performed when the Tof value is 0</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        the patiens whose Stop Bang questionnaire bigger tan 3 and planned for elective surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Aged18- 65 years With a stop bang score of 3 ASA I-II Mallampati I and II scores&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who were intubated in the intensive care unit during postoperative period,&#xD;
             those using CPAP device at home or those who received OSAS therapy, who had undergone&#xD;
             head and neck surgery or who had head surgery, central nervous system damage and&#xD;
             cardiovascular or pulmonary stability, neuromuscular disease patients, those with&#xD;
             known allergies to the anesthetic agents used, those whose written and verbal consent&#xD;
             cannot be obtained, smokers, pregnants and patients with ASA III and IV will not be&#xD;
             included in our study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>CELALEDDİN Y SOYALP</last_name>
    <role>Study Chair</role>
    <affiliation>VAN YUZUNCU YIL UNIVERSITY</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>CELALEDDİN SOYALP, Asist. Prof.</last_name>
    <phone>5068456504</phone>
    <email>c.soyalp@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>YUZKAT NUREDDIN, Asist. Prof</last_name>
    <phone>+905052294728</phone>
    <email>nyuzkat@gmail.com</email>
  </overall_contact_backup>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yuzuncu Yıl University</investigator_affiliation>
    <investigator_full_name>Celaleddin Soyalp</investigator_full_name>
    <investigator_title>Assist. prof.</investigator_title>
  </responsible_party>
  <keyword>stop bang</keyword>
  <keyword>Intubation Without Muscle Relaxation</keyword>
  <keyword>Post Operative Recovery</keyword>
  <keyword>TOF</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03824470
org study id: stop bang
nct id: NCT03824470
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary aim of this study is to research the effect of intubation without muscle relaxant
      on post-operative recovery conditions in patients with OSAS (obstructive sleep apnea
      syndrome). Our secondary aim is to research the hemodynamic parameters in intraoperative
      period and complications such as sore throat and laryngospasm voice limitation in the
      postoperative period.
Study Protocol, Methods and Procedures to be Applied:

      This study will be carried out as double blinded randomized controlled after the approval of
      the ethics committee of our hospital. By carrying out the Stop Bang questionnaire which is a
      practical and highly sensitive test, 60 patients ranging from 18 to 65 years with a stop bang
      score of 3 and ASA I-II and mallampati I and II scores will be included to the study. The
      patients included in the study will be divided into two groups of 30 people randomly with a
      closed envelope method. Patients who were intubated in the intensive care unit during
      postoperative period, those using CPAP device at home or those who received OSAS therapy, who
      had undergone head and neck surgery or who had head surgery, central nervous system damage
      and cardiovascular or pulmonary stability, neuromuscular disease patients, those with known
      allergies to the anesthetic agents used, those whose written and verbal consent cannot be
      obtained, smokers, pregnants and patients with ASA III and IV will not be included in our
      study. All patients will be seen a day in advance and after performing stop bang test, those
      with test score of 3 and above will be included in the study and their physical examinations
      and laboratory findings will be evaluated. The demographic data of the patients will be
      recorded. The physician performing the anesthesia and the evaluating physician will be
      different people. The evaluating physician will not know which anesthetic agent is used to
      the patients. The group to be performed Esmeron will be named Group E and the group to be
      given Remifentanil will be named Group R. All patients included in the study will be taken to
      the operation room and the hemodynamic parameters (heart rate, mean blood pressure values,
      SpO2) will be recorded by naninvasive monitoring. The data obtained will be considered as
      basal. All patients will be given 2 mg / kg demisolam for the purpose of sedation. General
      anesthesia will be done by connecting the Tof device to the patients. Anesthesia induction
      will be done to anesthesia induction Group R with 1 mg / kg lidocaine, 4 mcg / kg
      remifentanil and 2 mg / kg propofol intravenously. In group E, after the administration of 1
      mg / kg lidocaine, 2 mg / kg propofol, 1 mcg / kg remifentanil and 0.6 mg / kg rocuronium,
      patients in both groups will be intubated and general anesthesia will be performed when the
      Tof value is 0. During intubation; intubation difficulty will be evaluated and recorded by
      intubation scoring system. Anesthesia maintenance in both groups will be provided with 8%
      desflurane, 40% O2, 60% dry air and iv. 0.025 mcg / kg / min remifentanil fusion. During the
      study, the recorded basal hemodynamic parameters of the patients will be recorded in the
      first 20 minutes of the operation with a 5-minute interval and 10-minute interval after the
      20th minute. In case of a change of 20% in any one according to basal, it will be intervened
      immediately. In order to provide the depth of anesthesia before the operation, patients will
      be monitored with TOF device and the depth of anesthesia will be provided. Shortly after the
      end of the surgery, the gases will be cut off and the Tof value of 70% and above will be
      recorded. When Tof is 70%, Group R will be given 10 cc physiological saline intravenously. In
      order to antagonize the muscle relaxant effect in Group E, 2 / mg / kg sguamadex will be
      administered intravenously by diluting with 10 cc physiological saline. Patients will be
      extubated when the tof value of both groups is 90%. The durations from 70% to 90% of the Tof
      value, spontaneous eye opening duration after the patient is extubated, duration of
      extubation, response duration to commands, duration until modified aldrete score is 10,
      surgeon satisfaction (good, bad, moderate) and duration of surgery will be recorded. The
      operation will be terminated by recording whether there is a need for ventilation with sore
      throat, laryngospasm volume restriction, desaturation and mask.
observational model: Other
time perspective: Prospective
measure: Post Operative Recovery
time frame: 1 hour
description: The durations from 70% to 90% of the Tof value, spontaneous eye opening duration after the patient is extubated, duration of extubation, response duration to commands, duration until modified aldrete score is 10
arm group label: Group E(rocuronium)
description: E, after the administration of 1 mg / kg lidocaine, 2 mg / kg propofol, 1 mcg / kg remifentanil and 0.6 mg / kg rocuronium intravenously, patients will be intubated and general anesthesia will be performed when the Tof value is 0.
arm group label: Group R (remifentanil)
description: 1 mg / kg lidocaine, 4 mcg / kg remifentanil and 2 mg / kg propofol intravenously.patients will be intubated and general anesthesia will be performed when the Tof value is 0
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
last name: CELALEDDİN Y SOYALP
role: Study Chair
affiliation: VAN YUZUNCU YIL UNIVERSITY
last name: CELALEDDİN SOYALP, Asist. Prof.
phone: 5068456504
email: c.soyalp@hotmail.com
last name: YUZKAT NUREDDIN, Asist. Prof
phone: +905052294728
email: nyuzkat@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Yuzuncu Yıl University
investigator full name: Celaleddin Soyalp
investigator title: Assist. prof.
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Syndrome
sharing ipd: Undecided