<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20180416039326N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-14</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of cardiovascular response to laryngoscopy and endotracheal intubation in induction of anesthesia with etomidate and thiopental sodium - Midazolam</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation and comparison of cardiovascular response to laryngoscopy and endotracheal intubation in induction of anesthesia with etomidate and thiopental sodium - Midazolam</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>78</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45573</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation to intervention and control groups using Random allocation software, Blinding description: In this study, the patient and observer who collects the information will not be in the course of the study, as the drug is injected by the planter, but the data will be collected by another person who is not in the study and the information will be double-blinded.</study_design>
      <phase>2</phase>
      <hc_freetext>Cardiovascular response.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: after receiving 5 ml/kg of ringer lactate and pre-oxygenation for patients, induction of anesthesia was performed including Fentanyl 2mcg/kg, Etomidate 0.3mg/kg, Atracurium 0.5 m/kg.Then patients underwent mechanical ventilation by mask for three minutes.Then the airway is protected by ETT and the patient is attached to the anesthetic machine and is mechanically ventilated and maintained anesthetized with iso-fluorine 0.8-1.2 Mac, with oxygen and N2O of 50%. Intervention 2: Second intervention group: after receiving 5 ml/kg of ringer lactate and pre-oxygenation for patients, induction of anesthesia was performed including Fentanyl 2mcg/kg, Thiopental sodium 2.5 mg/kg and Midazolam 0.075 mg/kg, Atracurium 0.5 m/kg.Then patients underwent mechanical ventilation by mask for three minutes.Then the airway is protected by ETT and the patient is attached to the anesthetic machine and is mechanically ventilated and maintained anesthetized with iso-fluorine 0.8-1.2 Mac, with oxygen and N2O of 50%.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamidreza Shetabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Al-Zahra Therapeutic Training Center, Sofeh Boulevard</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174675731</zip>
        <telephone>+98 31 3668 5555</telephone>
        <email>hamidshetabi@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamidreza Shetabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Al-Zahra Therapeutic Training Center, Sofeh Boulevard</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174675731</zip>
        <telephone>+98 31 3668 5555</telephone>
        <email>hamidshetabi@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who are candidates for short-term elective surgery (less than2 hours) under general anesthesia
Age between 18 to 70 years old
ASA1&amp;2</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Obese patients
Pregnant women
Uncontrolled diabetic patients
Uncontrolled COPD patients
Uncontrolled cardiovascular patients
Chronic analgesic or sedative use
BMI more than 25 kg/m2
Any Uncontrolled systemic disease
Predicting the difficulty of airway protection
Any sensitivity or allergies to the anesthetics agent used</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Other comp</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>T88.5</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: after receiving 5 ml/kg of ringer lactate and pre-oxygenation for patients, induction of anesthesia was performed including Fentanyl 2mcg/kg, Etomidate 0.3mg/kg, Atracurium 0.5 m/kg.Then patients underwent mechanical ventilation by mask for three minutes.Then the airway is protected by ETT and the patient is attached to the anesthetic machine and is mechanically ventilated and maintained anesthetized with iso-fluorine 0.8-1.2 Mac, with oxygen and N2O of 50%</i_keyword>
      <i_keyword>Second intervention group: after receiving 5 ml/kg of ringer lactate and pre-oxygenation for patients, induction of anesthesia was performed including Fentanyl 2mcg/kg, Thiopental sodium 2.5 mg/kg and Midazolam 0.075 mg/kg, Atracurium 0.5 m/kg.Then patients underwent mechanical ventilation by mask for three minutes.Then the airway is protected by ETT and the patient is attached to the anesthetic machine and is mechanically ventilated and maintained anesthetized with iso-fluorine 0.8-1.2 Mac, with oxygen and N2O of 50%</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Heart rate. Timepoint: Basic time, minutes 1 and 3 after induction and minutes 1, 3, 5 and 10 after intubation. Method of measurement: Electrocardiogram (EKG).</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: Basic time, minutes 1 and 3 after induction and minutes 1, 3, 5 and 10 after intubation. Method of measurement: Barometer.</prim_outcome>
      <prim_outcome>Mean arterial pressure. Timepoint: Basic time, minutes 1 and 3 after induction and minutes 1, 3, 5 and 10 after intubation. Method of measurement: Barometer.</prim_outcome>
      <prim_outcome>Oxygen saturation percentage. Timepoint: Basic time, minutes 1 and 3 after induction and minutes 1, 3, 5 and 10 after intubation. Method of measurement: Pulse oximetry.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-14</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan University of Medical Sciences, Hezar Jarib Street Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
