<?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>IRCT2013012012203N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-11-09</date_registration>
      <primary_sponsor>Vice Chancellor For Research,Ghzvin University Of Medical Science</primary_sponsor>
      <public_title>Effects of Alfentanil on Hemodynamic Changes due to Endotracheal Intubation in Elective Cesarean Section under General Anesthesia</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Alfentanil on Hemodynamic Changes due to Endotracheal Intubation in Elective Cesarean Section under General Anesthesia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12303</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Elective cesearean  under general anesthesia.</hc_freetext>
      <i_freetext>Intervention 1: in interventional group  patint give 10 mic/kg alfentanil befor induction. Intervention 2: control group give the same volum of intervention group normal salin befor induction.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link>DOI: 10.4103/0019-5049.170033</results_url_link>
      <results_summary>	 	&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
Background and Aims: Endotracheal intubation can produce severe maternal haemodynamic changes during caesarean sections under general anaesthesia. However, administration of narcotics before endotracheal intubation to prevent these changes may affect the Apgar score in neonates. This study was designed to evaluate the effect of intravenous alfentanil on haemodynamic changes due to endotracheal intubation in elective caesarean sections performed under general anaesthesia. Methods: Fifty parturients were randomly divided into two equal groups. Patients in the first group received alfentanil 10 μg/kg and in the second group received placebo intravenously 1 min before induction of anaesthesia for elective caesarean section. Haemodynamic parameters and bispectral index system (BIS) in mothers, peripheral capillary oxygen saturation (SpO 2 ) and Apgar score in the newborn were assessed. Results: Changes in systolic blood pressure were significant at 1, 5 and 10 min after intubation between two groups. Changes in diastolic blood pressure were significantly less in alfentanil group, 1 min after induction of anaesthesia and 1 min after endotracheal intubation. Mean heart rate at 1 min after induction and at 1 and 5 min after intubation also reduced significantly in this group. Conclusion: Alfentanil use was associated with decreases or minimal increases in maternal systolic and diastolic blood pressures and heart rate after endotracheal intubation.           </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>Nilofar Masoudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghazvin University Of Medical Science,Navab Avenue,Ghazvin</address>
        <city>Ghazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3413996136</zip>
        <telephone>+98 28 1335 9557</telephone>
        <email>nmasoudi@qums.ac.ir</email>
        <affiliation>Ghazvin University Of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>nilofar masoudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghazvin University Of Medical Science Ghazvin,Navab avenue,Gazvin</address>
        <city>Ghazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3413996136</zip>
        <telephone>+98 28 1335 9557</telephone>
        <email>nmasoudi@qums.ac.ir</email>
        <affiliation>Gazvin University Of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusin criteria:patient age 20_40year; ASA 1 ; elective cesarean section.   &#13;
exclusin criteria:emergency ceserean; using antihypertensive drug; analgesic drug ;psychiatric drugs.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>in interventional group  patint give 10 mic/kg alfentanil befor induction</i_keyword>
      <i_keyword>control group give the same volum of intervention group normal salin befor induction</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Heart rate. Timepoint: evey 2 minute until delivery thenevery 5 minute to the end of surgery. Method of measurement: number of heart rate in one minute.</prim_outcome>
      <prim_outcome>Measuring systolic and diastolic blood pressur. Timepoint: evey 2 minute until delivery thenevery 5 minute to the end of surgery. Method of measurement: with cuff of blood pressure measuring.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Bispecteral Index. Timepoint: every 2 minute unti delivery and then every 5 minute to the end of surgery. Method of measurement: level of consciousness.</sec_outcome>
      <sec_outcome>Saturation of neonate. Timepoint: after birth of neonet measuring. Method of measurement: level of oxygen in arterial blood measurig with pulse oxymetry.</sec_outcome>
      <sec_outcome>Apgar scor. Timepoint: 1 minute and 5 after birth. Method of measurement: level of consciousness in 1and 5min after birth.</sec_outcome>
      <sec_outcome>Awarness. Timepoint: after awaking in recovery. Method of measurement: time of maternal recall.</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,Ghzvin University Of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-05-22</approval_date>
        <contact_name>Ghazvin University Of Medical Science</contact_name>
        <contact_address>Ghazvin University Of Medical Science, Navab Avenue ,Ghazvin Ghazvin  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-05-22</approval_date>
        <contact_name>Gzvin University Of Medical Science</contact_name>
        <contact_address>Gzvin University Of Medical Science,Navab avenue Gazvin  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
