<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/NCT03814330</url>
  </required_header>
  <id_info>
    <org_study_id>sedatakbas5</org_study_id>
    <nct_id>NCT03814330</nct_id>
  </id_info>
  <brief_title>A Comparison of Sedation/Analgesia &amp; LMA on Anxiety Level and Patient Satisfaction in In-Vitro Fertilization</brief_title>
  <acronym>IVF</acronym>
  <official_title>A Comparison of Two Different Anesthetic Application (Sedation / Analgesia &amp; LMA) on Anxiety Level and Patient Satisfaction in Patients With in Vitro Fertilization: Prospective Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inonu University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inonu 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>
      In vitro fertilization (IVF) is a new expertise of our age. Anesthesia during the assisted&#xD;
      reproduction technique is usually required during oocyte removal, which is one of the basic&#xD;
      steps throughout the entire procedure. Until now, different anesthetic techniques such as&#xD;
      conscious sedation, general anesthesia and regional anesthesia have been tried, no&#xD;
      superiority has been proved against each other. The main point of anesthesia management in&#xD;
      IVF is to minimize anesthesia exposure to avoid harmful effects on embryo division and&#xD;
      fertilization.&#xD;
&#xD;
      The aim of this prospective randomized clinical trial was to compare two different anesthesia&#xD;
      applications (sedation &amp; laryngeal mask airway) on anxiety and patient satisfaction in&#xD;
      patients with IVF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In vitro fertilization (IVF) is a new expertise of our age. Anesthesia during the assisted&#xD;
      reproduction technique is usually required during oocyte removal, which is one of the basic&#xD;
      steps throughout the entire procedure. Until now, different anesthetic techniques such as&#xD;
      conscious sedation, general anesthesia and regional anesthesia have been tried, no&#xD;
      superiority has been proved against each other. The main point of anesthesia management in&#xD;
      IVF is to minimize anesthesia exposure to avoid harmful effects on embryo division and&#xD;
      fertilization.&#xD;
&#xD;
      IVF requires the collection of mature oocytes from the ovaries of infertile patients. These&#xD;
      oocytes are then fertilized in vitro and allowed to become embryos. Afterwards, these embryos&#xD;
      are transferred into the uterus of the patients. Ultrasonography-guided transvaginal&#xD;
      aspiration makes oocyte intake less invasive compared to prior techniques and can be&#xD;
      administered within 30 minutes. With the development of this method, trauma was minimalized&#xD;
      and side effects were reduced. However, the possible effects of different anesthetics on&#xD;
      oocytes are still being discussed. The potential side effects of different anesthesia&#xD;
      applications have been observed not only in patients receiving oocytes, but also in embryo&#xD;
      development and pregnancy success due to the quality of oocytes. The pain of patients is&#xD;
      common after the puncture of the vaginal fornix. It is usually defined as deep menstrual&#xD;
      pain, quickly disappears and leaves a mild abdominal pain. Therefore, the anesthetist should&#xD;
      perform adequate pain relief to immobilize the patient to avoid the risk of perforating the&#xD;
      vessels during the procedure. Another challenge for the anesthesiologist is to alleviate the&#xD;
      increased anxiety associated with social and psychological stress associated with IVF.&#xD;
&#xD;
      Anxiety may develop before and after the procedure, especially in patients undergoing oocyte&#xD;
      collection. The patient's anxiety is usually present before entering the operating room. The&#xD;
      assessment, which was started to be developped by investigators, was aimed to measure state&#xD;
      anxiety levels in normal and non-normal individuals. State-Trait Anxiety Inventory measures&#xD;
      state anxiety levels and is an easy-to-implement inventory that the individual can answer on&#xD;
      his/her own. The State Anxiety Scale determines how the individual feels himself / herself at&#xD;
      a given moment and under certain conditions. It is widely used in preoperative anxiety&#xD;
      measurement.&#xD;
&#xD;
      Patient satisfaction depends on the patient's expectations and the benefits expected by the&#xD;
      patients with the service they receive. Patient satisfaction is the result of meeting the&#xD;
      wishes and expectations of the patients. An investigator has developed the Recovery Quality&#xD;
      Score-40 (Quality of Recovery Score) and is used to measure the quality of postoperative&#xD;
      recovery. This form consists 40 items and is divided into 5 subgroups according to various&#xD;
      aspects of the improvement. There are a total of 40 items, 9 related to emotional state, 12&#xD;
      related to physical comfort, 7 related to psychological support, 5 related to physical&#xD;
      independence and 7 items related to pain. The questionnaire is scored as a minimum of 40 to a&#xD;
      maximum of 200. No special training is required for the implementation of the survey. The&#xD;
      fact that the patient can perform the survey on his own and can be done in a short time gives&#xD;
      a significant advantage.&#xD;
&#xD;
      The aim of this prospective randomized clinical trial was to compare two different anesthesia&#xD;
      applications (sedation &amp; laryngeal mask airway) on anxiety and patient satisfaction in&#xD;
      patients with IVF.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 24, 2019</start_date>
  <completion_date type="Actual">June 21, 2019</completion_date>
  <primary_completion_date type="Actual">May 21, 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>Prospective Randomized Clinical Trial</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>State-Trait Anxiety Inventory</measure>
    <time_frame>State-Trait Anxiety Inventory will be performed to the all patients 2 hours before the IVF procedure.</time_frame>
    <description>State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. The State Anxiety Scale determines how the individual feels himself / herself at a given moment and under certain conditions. It is widely used in preoperative anxiety measurement. State-Trait Anxiety Inventory has 40 items, 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. Responses for the State Anxiety scale assess intensity of current feelings &quot;at this moment&quot;: 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Responses for the Trait Anxiety scale assess frequency of feelings &quot;in general&quot;: 1) almost never, 2) sometimes, 3) often, and 4) almost always. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>State-Trait Anxiety Inventory</measure>
    <time_frame>State-Trait Anxiety Inventory will be performed to the all patients 4 hours after the IVF procedure.</time_frame>
    <description>State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. The State Anxiety Scale determines how the individual feels himself / herself at a given moment and under certain conditions. It is widely used in preoperative anxiety measurement. State-Trait Anxiety Inventory has 40 items, 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. Responses for the State Anxiety scale assess intensity of current feelings &quot;at this moment&quot;: 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Responses for the Trait Anxiety scale assess frequency of feelings &quot;in general&quot;: 1) almost never, 2) sometimes, 3) often, and 4) almost always. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Recovery Score</measure>
    <time_frame>Quality of Recovery Score will be performed to the all patients 24 hours after the IVF procedure</time_frame>
    <description>Quality of Recovery Score is a global measure of quality of recovery. It incorporates five dimensions of health: patient support, comfort, emotions, physical independence, and pain; each item is graded on a five-point Likert scale. Quality of Recovery Scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). This consists 40 items and is divided into 5 subgroups according to various aspects of the improvement. There are a total of 40 items, 9 related to emotional state, 12 related to physical comfort, 7 related to psychological support, 5 related to physical independence and 7 items related to pain. The questionnaire is scored as a minimum of 40 to a maximum of 200.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)</time_frame>
    <description>Heart rate is measured as beats/minute on the anesthesia monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean arterial pressure</measure>
    <time_frame>From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)</time_frame>
    <description>Mean arterial pressure is measured as mmHg on the anesthesia monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peripheral oxygen saturation</measure>
    <time_frame>From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)</time_frame>
    <description>Peripheral oxygen saturation is measured as percentage (%) on the anesthesia monitor</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Anesthesia</condition>
  <condition>In-vitro Fertilization</condition>
  <condition>Analgesia</condition>
  <arm_group>
    <arm_group_label>Sedation/Analgesia</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients with applied sedation analgesia will perform State-Trait Anxiety Inventory and Quality of Recovery Score</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laryngeal Mask Airway</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with applied Laryngeal Mask Airway will perform State-Trait Anxiety Inventory and Quality of Recovery Score</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>State-Trait Anxiety Inventory</intervention_name>
    <description>State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. State-Trait Anxiety Inventory determines how the individual feels himself / herself at a given moment and under certain conditions. It is widely used in preoperative anxiety measurement</description>
    <arm_group_label>Laryngeal Mask Airway</arm_group_label>
    <arm_group_label>Sedation/Analgesia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Quality of Recovery Score</intervention_name>
    <description>Recovery Quality Score-40 (Quality of Recovery Score) and is used to measure the quality of postoperative recovery. This form consists 40 items and is divided into 5 subgroups according to various aspects of the improvement. There are a total of 40 items, 9 related to emotional state, 12 related to physical comfort, 7 related to psychological support, 5 related to physical independence and 7 items related to pain. The questionnaire is scored as a minimum of 40 to a maximum of 200.</description>
    <arm_group_label>Laryngeal Mask Airway</arm_group_label>
    <arm_group_label>Sedation/Analgesia</arm_group_label>
    <other_name>Recovery Quality Score-40</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sedation/Analgesia</intervention_name>
    <description>Patients will be performed the procedure with sedation/analgesia under the condition of spontaneous breathing.</description>
    <arm_group_label>Sedation/Analgesia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laryngeal Mask Airway</intervention_name>
    <description>Patients will be performed the procedure with Laryngeal Mask Airway during the procedure. Laryngeal Mask Airway is a supraglottic airway device to ventilate the patients during anesthetic procedure.</description>
    <arm_group_label>Laryngeal Mask Airway</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiology (ASA) scores of I-II&#xD;
&#xD;
          -  Aged 18-55 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiology (ASA) scores of III-IV&#xD;
&#xD;
          -  Under 18 years of age&#xD;
&#xD;
          -  Over 55 years of age,&#xD;
&#xD;
          -  Uncontrolled diabetes mellitus, cardiovascular, pulmonary disease, cerebrovascular&#xD;
             events,&#xD;
&#xD;
          -  Patients with an allergy to anesthetic drugs&#xD;
&#xD;
          -  Pregnants&#xD;
&#xD;
          -  Patients who refused informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Patients with In-Vitro Fertilization</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sedat Akbas, Asst. Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Inonu University Medical Faculty</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sedat Akbas</name>
      <address>
        <city>Malatya</city>
        <state>Türkiye-Türkçe</state>
        <zip>44090</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Piroli A, Marci R, Marinangeli F, Paladini A, Di Emidio G, Giovanni Artini P, Caserta D, Tatone C. Comparison of different anaesthetic methodologies for sedation during in vitro fertilization procedures: effects on patient physiology and oocyte competence. Gynecol Endocrinol. 2012 Oct;28(10):796-9. doi: 10.3109/09513590.2012.664193. Epub 2012 Mar 16.</citation>
    <PMID>22420562</PMID>
  </reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>August 16, 2019</last_update_submitted>
  <last_update_submitted_qc>August 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Inonu University</investigator_affiliation>
    <investigator_full_name>Sedat AKBAS</investigator_full_name>
    <investigator_title>Asst. Prof. Dr. Sedat Akbas</investigator_title>
  </responsible_party>
  <keyword>Anesthesia management</keyword>
  <keyword>In-vitro Fertilization</keyword>
  <keyword>Sedation-Analgesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Agnosia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 18, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT03814330/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03814330
org study id: sedatakbas5
nct id: NCT03814330
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In vitro fertilization (IVF) is a new expertise of our age. Anesthesia during the assisted
      reproduction technique is usually required during oocyte removal, which is one of the basic
      steps throughout the entire procedure. Until now, different anesthetic techniques such as
      conscious sedation, general anesthesia and regional anesthesia have been tried, no
      superiority has been proved against each other. The main point of anesthesia management in
      IVF is to minimize anesthesia exposure to avoid harmful effects on embryo division and
      fertilization.

      The aim of this prospective randomized clinical trial was to compare two different anesthesia
      applications (sedation & laryngeal mask airway) on anxiety and patient satisfaction in
      patients with IVF.
In vitro fertilization (IVF) is a new expertise of our age. Anesthesia during the assisted
      reproduction technique is usually required during oocyte removal, which is one of the basic
      steps throughout the entire procedure. Until now, different anesthetic techniques such as
      conscious sedation, general anesthesia and regional anesthesia have been tried, no
      superiority has been proved against each other. The main point of anesthesia management in
      IVF is to minimize anesthesia exposure to avoid harmful effects on embryo division and
      fertilization.

      IVF requires the collection of mature oocytes from the ovaries of infertile patients. These
      oocytes are then fertilized in vitro and allowed to become embryos. Afterwards, these embryos
      are transferred into the uterus of the patients. Ultrasonography-guided transvaginal
      aspiration makes oocyte intake less invasive compared to prior techniques and can be
      administered within 30 minutes. With the development of this method, trauma was minimalized
      and side effects were reduced. However, the possible effects of different anesthetics on
      oocytes are still being discussed. The potential side effects of different anesthesia
      applications have been observed not only in patients receiving oocytes, but also in embryo
      development and pregnancy success due to the quality of oocytes. The pain of patients is
      common after the puncture of the vaginal fornix. It is usually defined as deep menstrual
      pain, quickly disappears and leaves a mild abdominal pain. Therefore, the anesthetist should
      perform adequate pain relief to immobilize the patient to avoid the risk of perforating the
      vessels during the procedure. Another challenge for the anesthesiologist is to alleviate the
      increased anxiety associated with social and psychological stress associated with IVF.

      Anxiety may develop before and after the procedure, especially in patients undergoing oocyte
      collection. The patient's anxiety is usually present before entering the operating room. The
      assessment, which was started to be developped by investigators, was aimed to measure state
      anxiety levels in normal and non-normal individuals. State-Trait Anxiety Inventory measures
      state anxiety levels and is an easy-to-implement inventory that the individual can answer on
      his/her own. The State Anxiety Scale determines how the individual feels himself / herself at
      a given moment and under certain conditions. It is widely used in preoperative anxiety
      measurement.

      Patient satisfaction depends on the patient's expectations and the benefits expected by the
      patients with the service they receive. Patient satisfaction is the result of meeting the
      wishes and expectations of the patients. An investigator has developed the Recovery Quality
      Score-40 (Quality of Recovery Score) and is used to measure the quality of postoperative
      recovery. This form consists 40 items and is divided into 5 subgroups according to various
      aspects of the improvement. There are a total of 40 items, 9 related to emotional state, 12
      related to physical comfort, 7 related to psychological support, 5 related to physical
      independence and 7 items related to pain. The questionnaire is scored as a minimum of 40 to a
      maximum of 200. No special training is required for the implementation of the survey. The
      fact that the patient can perform the survey on his own and can be done in a short time gives
      a significant advantage.

      The aim of this prospective randomized clinical trial was to compare two different anesthesia
      applications (sedation & laryngeal mask airway) on anxiety and patient satisfaction in
      patients with IVF.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective Randomized Clinical Trial
primary purpose: Screening
masking: Single (Participant)
measure: State-Trait Anxiety Inventory
time frame: State-Trait Anxiety Inventory will be performed to the all patients 2 hours before the IVF procedure.
description: State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. The State Anxiety Scale determines how the individual feels himself / herself at a given moment and under certain conditions. It is widely used in preoperative anxiety measurement. State-Trait Anxiety Inventory has 40 items, 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. Responses for the State Anxiety scale assess intensity of current feelings "at this moment": 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Responses for the Trait Anxiety scale assess frequency of feelings "in general": 1) almost never, 2) sometimes, 3) often, and 4) almost always. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms.
measure: State-Trait Anxiety Inventory
time frame: State-Trait Anxiety Inventory will be performed to the all patients 4 hours after the IVF procedure.
description: State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. The State Anxiety Scale determines how the individual feels himself / herself at a given moment and under certain conditions. It is widely used in preoperative anxiety measurement. State-Trait Anxiety Inventory has 40 items, 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. Responses for the State Anxiety scale assess intensity of current feelings "at this moment": 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Responses for the Trait Anxiety scale assess frequency of feelings "in general": 1) almost never, 2) sometimes, 3) often, and 4) almost always. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms.
measure: Quality of Recovery Score
time frame: Quality of Recovery Score will be performed to the all patients 24 hours after the IVF procedure
description: Quality of Recovery Score is a global measure of quality of recovery. It incorporates five dimensions of health: patient support, comfort, emotions, physical independence, and pain; each item is graded on a five-point Likert scale. Quality of Recovery Scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). This consists 40 items and is divided into 5 subgroups according to various aspects of the improvement. There are a total of 40 items, 9 related to emotional state, 12 related to physical comfort, 7 related to psychological support, 5 related to physical independence and 7 items related to pain. The questionnaire is scored as a minimum of 40 to a maximum of 200.
measure: Heart rate
time frame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
description: Heart rate is measured as beats/minute on the anesthesia monitor
measure: Mean arterial pressure
time frame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
description: Mean arterial pressure is measured as mmHg on the anesthesia monitor
measure: Peripheral oxygen saturation
time frame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
description: Peripheral oxygen saturation is measured as percentage (%) on the anesthesia monitor
arm group label: Sedation/Analgesia
arm group type: Placebo Comparator
description: Patients with applied sedation analgesia will perform State-Trait Anxiety Inventory and Quality of Recovery Score
arm group label: Laryngeal Mask Airway
arm group type: Active Comparator
description: Patients with applied Laryngeal Mask Airway will perform State-Trait Anxiety Inventory and Quality of Recovery Score
intervention type: Diagnostic Test
intervention name: State-Trait Anxiety Inventory
description: State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. State-Trait Anxiety Inventory determines how the individual feels himself / herself at a given moment and under certain conditions. It is widely used in preoperative anxiety measurement
arm group label: Laryngeal Mask Airway
arm group label: Sedation/Analgesia
intervention type: Diagnostic Test
intervention name: Quality of Recovery Score
description: Recovery Quality Score-40 (Quality of Recovery Score) and is used to measure the quality of postoperative recovery. This form consists 40 items and is divided into 5 subgroups according to various aspects of the improvement. There are a total of 40 items, 9 related to emotional state, 12 related to physical comfort, 7 related to psychological support, 5 related to physical independence and 7 items related to pain. The questionnaire is scored as a minimum of 40 to a maximum of 200.
arm group label: Laryngeal Mask Airway
arm group label: Sedation/Analgesia
other name: Recovery Quality Score-40
intervention type: Other
intervention name: Sedation/Analgesia
description: Patients will be performed the procedure with sedation/analgesia under the condition of spontaneous breathing.
arm group label: Sedation/Analgesia
intervention type: Device
intervention name: Laryngeal Mask Airway
description: Patients will be performed the procedure with Laryngeal Mask Airway during the procedure. Laryngeal Mask Airway is a supraglottic airway device to ventilate the patients during anesthetic procedure.
arm group label: Laryngeal Mask Airway
criteria: 
gender: Female
gender based: Yes
gender description: Patients with In-Vitro Fertilization
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sedat Akbas, Asst. Prof.
role: Study Director
affiliation: Inonu University Medical Faculty
facility: 
country: Turkey
citation: Piroli A, Marci R, Marinangeli F, Paladini A, Di Emidio G, Giovanni Artini P, Caserta D, Tatone C. Comparison of different anaesthetic methodologies for sedation during in vitro fertilization procedures: effects on patient physiology and oocyte competence. Gynecol Endocrinol. 2012 Oct;28(10):796-9. doi: 10.3109/09513590.2012.664193. Epub 2012 Mar 16.
PMID: 22420562
responsible party type: Principal Investigator
investigator affiliation: Inonu University
investigator full name: Sedat AKBAS
investigator title: Asst. Prof. Dr. Sedat Akbas
mesh term: Agnosia
sharing ipd: No
provided document: 