<?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>IRCT138905114492N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2009-04-04</date_registration>
      <primary_sponsor>Vice chancellor for research, Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison between drugs on hemodynamic changes during tacheal intubation for CABG</public_title>
      <acronym></acronym>
      <scientific_title>comparison between Remifenil, lidocaine and fentanil on hemodynamic changes on CABG during laryngoscopy and tracheal intubation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4792</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: routine group as a control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Hemodynamic change, Local anesthesia, tracheal intubation , CABG. Condition 2: Atherosclerotic heart disease.</hc_freetext>
      <i_freetext>Intervention 1: Remifentanil 0.5 microgram per kilogram , 3 min before laryngoscopy. Intervention 2: Spray of 10% lidocaine 2 puff to supraglotic 3 min before laryngoscopy. Intervention 3: Lidocaine IV 1.5 mg/kg 3 min before laryngoscopy. Intervention 4: Fentanyl 8 micro gram per kilogram 3 min prior Laryngoscopy. Intervention 5: Fentanyl 3-5 Micrograme per kilogram 3 min before laryngoscopy as routine or control group.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link>http://jmums.mazums.ac.ir/browse.php?a_id=610&amp;sid=1&amp;slc_lang=fa</results_url_link>
      <results_summary>           Background and purpose: Ït has been found that the use of different drugs for laryngoscopy preparation and tracheal intubation results in controversy. The aim of this study is to compare the haemodynamic effects of remifentanil with fentanyl for tracheal intubation in patients undergoing coronary artery bypass grafting (ÇÂBG). &lt;br /&gt;&#13;
Materials and methods: This is a randomized and double-blind study. We recruited 64 patients undergoing coronary artery bypass surgery. Subjects received in 3 separate groups: remifentanil, 5 microgram/kg, Fentanyl, 8 microgram/kg, and routine medication respectively. Systolic and diastolic blood pressure, heart rate and mean arterial pressure were measured during, before and after tracheal intubation and immediately, 1, 3, 5, 10, minutes after intubation. Patients were monitored for haemodynamic changes using electrocardiography. &lt;br /&gt;&#13;
Results: Sixty four patients were enrolled in the study. Twenty four patients age at 66 ± 5.7 (60-84) years, received remifentanil, 23 patients with mean age of 65.7 ± 6 (60-80) years made up the routin group, and 17 patients with mean age of 65 ± 4.8 (61-76) years received fentanyl. Blood pressure and heart rate decreased after induction of anaesthesia in all groups. SBP and DBP significantly decreased in remifentanil group in comparison with other groups (p= 0.01, 0.03). Ït was pssoble to control hemodynamic response to tracheal intubation in all groups, although it was better in remifentanil group than other groups. &lt;br /&gt;&#13;
Çonclusion: Âlthough the incidence of hypotension was higher, 0.5 microgram/kg of Remifentanil 8 microgram/kg of fentanyl and routine method (sufentanil) were all effective to attenuate patients’ blood pressure in response to tracheal intubation up to 3 minutes after intubation.  &lt;br /&gt;&#13;
 &lt;br /&gt;&#13;
Keywords: Remifentanil, fentanyl, hemodynamic responses, tracheal intubation, sufentanil, &lt;br /&gt;&#13;
</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Mohammad reza Haghshenas</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>moalem square, Deputy of research of Mazandaran University of Medical Sciences</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4817844718</zip>
        <telephone>+98 15 1325 7230</telephone>
        <email>mhaghshenas@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ebrahim Nasiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dept Anesthesia, operating room and Emergency Medicine, Mojtamehe Payambare Azam, Mazandaran University of Medical Sciences, Paramedical school.</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4818846693</zip>
        <telephone>+98 15 1354 3246</telephone>
        <email>rezanf2002@yahoo.com; enasiri@mazums.ac.ir; ebrahim.nasiri.f@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria are: CABG candidated patients, 50-85 years old, ASA III, IV&#13;
&#13;
Exclusion Criteria are : Difficult Intubation, laryngoscopy and tracheal intubation time more than 30 second, more than two time tried for intubation, Sensitivity to local anesthetic drugs</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>85 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>-</hc_code>
      <hc_code>I25.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>-</hc_keyword>
      <hc_keyword>Atherosclerotic heart disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Remifentanil 0.5 microgram per kilogram , 3 min before laryngoscopy</i_keyword>
      <i_keyword>Spray of 10% lidocaine 2 puff to supraglotic 3 min before laryngoscopy</i_keyword>
      <i_keyword>Lidocaine IV 1.5 mg/kg 3 min before laryngoscopy</i_keyword>
      <i_keyword>Fentanyl 8 micro gram per kilogram 3 min prior Laryngoscopy</i_keyword>
      <i_keyword>Fentanyl 3-5 Micrograme per kilogram 3 min before laryngoscopy as routine or control group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Systolic Blood pressure. Timepoint: from 2 to 5 minutes. Method of measurement: We used invasive arterial line blood pressure monitoring with datascope prouducted in USA.</prim_outcome>
      <prim_outcome>Diastolic Blood pressure. Timepoint: 2-5 min. Method of measurement: We used invasive arterial line blood pressure monitoring with datascope prouducted in USA.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: 2- 5 Min. Method of measurement: We used invasive arterial line blood pressure monitoring with datascope prouducted in USA.</prim_outcome>
      <prim_outcome>Premature ventricular contraction (PVC). Timepoint: Before intubation, continuous monitoring after intubation up to the 10th minute. Method of measurement: We used invasive arterial line blood pressure monitoring with datascope prouducted in USA.</prim_outcome>
      <prim_outcome>SPo2. Timepoint: 2- 5 minutes interval. Method of measurement: Pulse Oximetry instrument.</prim_outcome>
      <prim_outcome>Mean arterial pressure. Timepoint: 2-5 Min. Method of measurement: We used invasive arterial line blood pressure monitoring with datascope prouducted in USA.</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>Vice chancellor for research, Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2009-03-04</approval_date>
        <contact_name>Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Moalem Square, Chancelar of research of  Mazandaran University of Medical Sciences Sari  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
