<?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>IRCT20210117050057N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-19</date_registration>
      <primary_sponsor>Magrabi Eye, ENT and Dental Center, Doha, Qatar</primary_sponsor>
      <public_title>Comparison of the Effects of Dexmedetomidine and Fentanyl-Midazolam Combination on Mitigating Stress Response for Microlaryngoscopy</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effects of Dexmedetomidine and Fentanyl-Midazolam Combination on Mitigating Stress Response for Microlaryngoscopy: A Randomized, Double-Blind, Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54925</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomly assigned to  one of two groups using computer-generated software of randomization introduced into sealed opaque envelops which are sequentially numbered, Blinding description: An independent nurse, who did not participate in the study or data collection prepared all study drugs. These drugs were administered by another nurse who was blind to the study and the groups. The anesthesiologist, surgeon and data collectors were all blinded to the given study drugs and the envelops were opened immediately before administration by a person who did not participate in the observation.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Microlaryngoscopy.</hc_freetext>
      <i_freetext>Intervention 1: Dexmedetomidine group: 30 patients who received 1 µg/kg of dexmedetomidine over 10 minutes before anesthesia induction followed by 0.05 mg/kg/h as infusion after anesthesia induction. Intervention 2: Fentanyl-Midazolam group: 30 patients received fentanyl 0.8 µg/kg plus midazolam 0.05 mg/kg over 10 minutes before anesthesia induction followed by 1 µg/kg/h fentanyl and 0.05 mg/kg/h midazolam as infusion after anesthesia induction.</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 It is not yet known if there will be a plan to make this available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>MOHAMED ORIBY</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tanta</address>
        <city>Tanta</city>
        <country1>Egypt</country1>
        <zip>00000</zip>
        <telephone>+974 3305 9056</telephone>
        <email>oraiby500@hotmail.com</email>
        <affiliation>Faculty of Medicine, Tanta University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>MOHAMED ORIBY</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tanta</address>
        <city>Tanta</city>
        <country1>Egypt</country1>
        <zip>00000</zip>
        <telephone>+974 3305 9056</telephone>
        <email>oraiby500@hotmail.com</email>
        <affiliation>Faculty of Medicine, Tanta University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Qatar</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18-65 years
ASA grade I/III
Scheduled for microlaryngoscopy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with known allergy to study drugs
Coronary artery disease
Pulmonary disease
Arrhythmia
Pregnancy
Renal impairment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J38.7</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other diseases of larynx</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>Dexmedetomidine group: 30 patients who received 1 µg/kg of dexmedetomidine over 10 minutes before anesthesia induction followed by 0.05 mg/kg/h as infusion after anesthesia induction</i_keyword>
      <i_keyword>Fentanyl-Midazolam group: 30 patients received fentanyl 0.8 µg/kg plus midazolam 0.05 mg/kg over 10 minutes before anesthesia induction followed by 1 µg/kg/h fentanyl and 0.05 mg/kg/h midazolam as infusion after anesthesia induction</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hemodynamic stress response. Timepoint: Intraoperative. Method of measurement: Systolic Blood Pressure , Mean Arterial Pressure, Heart Rate were monitored.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Intraoperative requirement of propofol. Timepoint: Intraoperative. Method of measurement: Total dose guided by bispectral index.</sec_outcome>
      <sec_outcome>Sedation. Timepoint: Postoperative. Method of measurement: Ramsay score.</sec_outcome>
      <sec_outcome>Analgesia. Timepoint: Postoperative. Method of measurement: Visual Analogue Scale.</sec_outcome>
      <sec_outcome>Anesthesia duration. Timepoint: Intraoperative. Method of measurement: Time measurement.</sec_outcome>
      <sec_outcome>Recovery time. Timepoint: Postoperative. Method of measurement: Time measurement.</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>Magrabi Eye, ENT and Dental Center, Doha, Qatar</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-03-13</approval_date>
        <contact_name>Institutional Review Board (IRB) of Magrabi Eye &amp; ENT Center</contact_name>
        <contact_address>D ring road Doha Doha Qatar</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
