<?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>IRCT2014100719431N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-01-12</date_registration>
      <primary_sponsor>Iran University of Medical Science</primary_sponsor>
      <public_title>Effect of Hyoscine and Atropine on blood pressure ,heart rate in patient who treated by ECT</public_title>
      <acronym></acronym>
      <scientific_title>Comparisson of the effect of pretreatment with Hyoscine,Atropine and placebo on hemodynamic stability,recovery time,and ECT side effect</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17365</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Schizophrenia. Condition 2: Persistant delusional disorders. Condition 3: Acute and transient psychotic disorder. Condition 4: Manic disorder. Condition 5: Bipolar mood diorder. Condition 6: Depressive episode. Condition 7: Paranoid personality disorder.</hc_freetext>
      <i_freetext>Intervention 1: 20 patients accidentally are belong to first group.after initial monitoring and record of information,vital signs include systolic and diastolic blood pressure,pulse rate are recorded in data sheath.in this group all patient recive intravenous atropine 0.5mg (0.01 mg/kg) as pretreatment.induction of anesthesia is done with nesdonal 2mg/kg and succynil choline 0.5 mg/kg.&#13;
in all patients,blood pressure and pulse rate,time of consciousness ,recovery time, volume of respiratory secretions ,duration of convulsion will be record. Intervention 2: 20 patients accidentally are belong to second group.after initial monitoring and record of information,vital signs include systolic and diastolic blood pressure,pulse rate are recorded in data sheath.in this group all patient recive intravenous hyoscine 5-7mg (0.1 mg/kg) as pretreatment.induction of anesthesia is done with nesdonal 2mg/kg and succynil choline 0.5 mg/kg. in all patients,blood pressure and pulse rate ,time of consciousness ,recovery time, volume of respiratory secretions ,duration of convulsion  will be record. Intervention 3: 20 patients accidentally are belong to third group.after initial monitoring and record of information,vital signs include systolic and diastolic blood pressure,pulse rate are recorded in data sheath.in this group all patient recive intravenous sterile water 1 ml (0.01 ml/kg) as pretreatment.induction of anesthesia is done with nesdonal 2mg/kg and succynil choline 0.5 mg/kg. in all patients,blood pressure and pulse rate ,time of consciousness ,recovery time, volume of respiratory secretions ,duration of convulsion will be record.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Behnaz Karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Anesthesiology Department of Hazrat Rasool Akram Hospital, Niayesh street, Sattarkhan, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 4476 3217</telephone>
        <email>karimi.behnaz@gmail.com</email>
        <affiliation>Iran University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Ali Khatibi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Anesthesiology Department of Firoozgar Hospital, Vali asr street, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6650 9059</telephone>
        <email>alikhatibi2002@yahoo.com                                                                     khatibi</email>
        <affiliation>Iran University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patients according to psychological indication and psychologist confirmation are entered to study patients excep who are older than 70 and those have medical contraindication for atropine and hyoscine. patients have tachy cardia,bradycardia,arrythmia,hypotension and hypertension are excluded.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F20</hc_code>
      <hc_code>F22</hc_code>
      <hc_code>F23</hc_code>
      <hc_code>F30</hc_code>
      <hc_code>F31</hc_code>
      <hc_code>F32</hc_code>
      <hc_code>F60.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Schizophrenia</hc_keyword>
      <hc_keyword>Persistant delusional disorder</hc_keyword>
      <hc_keyword>Acute and transient psychotic disorder</hc_keyword>
      <hc_keyword>Manic episode</hc_keyword>
      <hc_keyword>Bipolar affective disorder</hc_keyword>
      <hc_keyword>Depressive episode</hc_keyword>
      <hc_keyword>Paranoid personality disorder</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>20 patients accidentally are belong to first group.after initial monitoring and record of information,vital signs include systolic and diastolic blood pressure,pulse rate are recorded in data sheath.in this group all patient recive intravenous atropine 0.5mg (0.01 mg/kg) as pretreatment.induction of anesthesia is done with nesdonal 2mg/kg and succynil choline 0.5 mg/kg.&#13;
in all patients,blood pressure and pulse rate,time of consciousness ,recovery time, volume of respiratory secretions ,duration of convulsion will be record.</i_keyword>
      <i_keyword>20 patients accidentally are belong to second group.after initial monitoring and record of information,vital signs include systolic and diastolic blood pressure,pulse rate are recorded in data sheath.in this group all patient recive intravenous hyoscine 5-7mg (0.1 mg/kg) as pretreatment.induction of anesthesia is done with nesdonal 2mg/kg and succynil choline 0.5 mg/kg. in all patients,blood pressure and pulse rate ,time of consciousness ,recovery time, volume of respiratory secretions ,duration of convulsion  will be record.</i_keyword>
      <i_keyword>20 patients accidentally are belong to third group.after initial monitoring and record of information,vital signs include systolic and diastolic blood pressure,pulse rate are recorded in data sheath.in this group all patient recive intravenous sterile water 1 ml (0.01 ml/kg) as pretreatment.induction of anesthesia is done with nesdonal 2mg/kg and succynil choline 0.5 mg/kg. in all patients,blood pressure and pulse rate ,time of consciousness ,recovery time, volume of respiratory secretions ,duration of convulsion will be record.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Heart rate. Timepoint: after and before pretreatment and after induction and immediately ,after 1,3 and 5 minutes from shock ,heart rate is measured in all patients. Method of measurement: heart rate is measuring by ECG monitoring.</prim_outcome>
      <prim_outcome>Duration of convulsion. Timepoint: after shock,from the firs movements of patientsto end of convulsion,time is recorded. Method of measurement: duration of convulsion is measured according to seconds.</prim_outcome>
      <prim_outcome>Time of recovery. Timepoint: from termination of convulsion to allertness of patient is called as recovery time.alertness means the ability of patients to obey orders. Method of measurement: time of recovery,allertness and obey is measuring according minutes.</prim_outcome>
      <prim_outcome>Volume of respiratory secretions. Timepoint: by convulsion termination ,respiratory secretions may ecceed normal amounts ,so we should suction them. Method of measurement: volume of secretions is measured according to how many times to sucction(1-3 times )1:dry  2:sialorrhea 3:huge amounts of secretions.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: after and before pretreatment and after induction and immediately ,after 1,3 and 5 minutes from shock ,blood pressure is measured in all patients. Method of measurement: blood pressure is measured by cuff around patients arm.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Cognition disorders. Timepoint: cognition disorders are recorded during recovery time. Method of measurement: cognition disorders according to diagnosis confirmation  by psychologist.</sec_outcome>
      <sec_outcome>Other complications. Timepoint: from the patients entrance to end of recovery. Method of measurement: every other complication occurs  is recorded by inspection and visualization.</sec_outcome>
      <sec_outcome>Primary diagnosis. Timepoint: at first after patients entrance, primary diagnosis  is recorded in data sheet. Method of measurement: at first  primary diagnosis is recorded from medical records.</sec_outcome>
      <sec_outcome>Age. Timepoint: at first after patients entrance, age is recorded. Method of measurement: age is recorded according to medical records.</sec_outcome>
      <sec_outcome>Sex. Timepoint: at first,after patients entrance, sex  is recorded. Method of measurement: at first sex  is recorded from medical records.</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>Iran University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-03-05</approval_date>
        <contact_name>Iran University  of Medical Science</contact_name>
        <contact_address>Hemmat High way Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
