<?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>IRCT20151219025600N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-07-24</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>Bolus dose of dexmedetomidine effect on hemodynamic  response to laryngoscopy</public_title>
      <acronym>SBP,DBP,MAP,HR</acronym>
      <scientific_title>Studying the bolus dose of Dexmedetomidine effect in attenuating hemodynamic stress response to laryngoscopy and tracheal intubation in hypertensive patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-07-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77780</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Other design features: no more explanation, Randomization description: The patients by block randomization will be allocated to equal groups of study and placebo using "random allocation" software providing computerized numbers. The numbers will be written on envelopes containing the drug or placebo notes and will be delivered to the anesthesia nurse as sealed, Blinding description: The patient and the researcher who evaluates the outcomes will not informed of patients allocation to the study and control groups. Both drug and placebo will be colorless prepared and injected in 50 cc syringes at equal volumes. Each patient will allocate a number using randomization allocation software in sealed envelopes containing the drug or placebo delivered to the anesthesia nurse. The researcher will not be informed of syringe content.</study_design>
      <phase>3</phase>
      <hc_freetext>Arterial Blood Pressure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Patients without or with hypertension class I-II at age 40-70. Intervention 2: Control group: Patients without or with hypertension class I-II at age 40-70 receiving placebo (normal saline infusion).</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Demographic and primary outcome data without identification can be shared.

When:
Research data will be available until April 2025 and there after.

To whom:
Only medical academic researchers have access to data.

Conditions:
No other condition is necessary for access.

Where to obtain:
Correspondent researcher
Shahram Shokoohi shokohi.sh@umsu.ac.ir

How to obtain:
Write to the corresponding researcher
Shahram Shokoohi shokohi.sh@umsu.ac.ir

Comments:
no more explanation</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shahram Shokohi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ersahd street, Modarres boulvard, Imam Khomeini University hospital</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5715789397</zip>
        <telephone>+98 44 3346 9931</telephone>
        <email>shokohi.sh@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahram Shokohi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam khomeini Univerity hospital,Ershad street, Modarres boulvard ,</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5715789397</zip>
        <telephone>00484433469931</telephone>
        <email>shokohi.sh@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>normotensive Patients
Stage I-II hypertensive patients
patients at age 40-70</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Difficult intubation
BMI more than 30
Patient receiving Clonidine
Pregnancy
Laryngoscopy more than 20 seconds
Emergency surgery
Patients with heart blocks
ASA class III and more
Patients with pheochromocytoma
Patients with thyroid disorders
Patients with neuropathy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hypertension (arterial)(benign)(essential)(malignant)(primary)(systemic)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Patients without or with hypertension class I-II at age 40-70</i_keyword>
      <i_keyword>Control group: Patients without or with hypertension class I-II at age 40-70 receiving placebo (normal saline infusion)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: At time zero(basic hemodynamics),T1(5 minutes after drug or placebo injection),T2(after induction of general anesthesia) T3(one minute after tracheal intubation),T4(3 minutes after intubation) T5(5 minutes after intubation) T6( 10 minutes after intubation). Method of measurement: Measuring using electronic cardiovascular monitoring device.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: At time zero(basic hemodynamics),T1(5 minutes after drug or placebo injection),T2(after induction of general anesthesia) T3(one minute after tracheal intubation),T4(3 minutes after intubation) T5(5 minutes after intubation) T6( 10 minutes after intubation). Method of measurement: Measuring using electronic cardiovascular monitoring device.</prim_outcome>
      <prim_outcome>Mean arterial pressure. Timepoint: At time zero(basic hemodynamics),T1(5 minutes after drug or placebo injection),T2(after induction of general anesthesia) T3(one minute after tracheal intubation),T4(3 minutes after intubation) T5(5 minutes after intubation) T6( 10 minutes after intubation). Method of measurement: Measuring using electronic cardiovascular monitoring device.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: At time zero(basic hemodynamics),T1(5 minutes after drug or placebo injection),T2(after induction of general anesthesia) T3(one minute after tracheal intubation),T4(3 minutes after intubation) T5(5 minutes after intubation) T6( 10 minutes after intubation). Method of measurement: Measuring using electronic cardiovascular monitoring device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hypnotic drug(propofol) induction dose in patients with hypertensive disease. Timepoint: At the end of anesthesia induction. Method of measurement: Propofol dose  needed for induction of anesthesia as milligram.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-02-28</approval_date>
        <contact_name>Research Ethics Committees of Urmia Univerity of Medical Scineces-Imam Khomeini University Hospital</contact_name>
        <contact_address>Imam Khomein teaching hospitalT Ershad street Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
