<?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>IRCT201608086280N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-10-02</date_registration>
      <primary_sponsor>Vice chancellor for research, Guilan  University of Medical Sciences</primary_sponsor>
      <public_title>The  Effect  of  remifentanil on Mini-mental status examination   after electroconvulsive therapy in major depressive patients.</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the incidence and severity of cognitive impairment after electroconvulsive therapy under general anesthesia with remifentanil in patients referred to electroconvulsive therapy   shaft center , Rasht in 1395</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-09-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6727</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>The Patients With Major Depressive Disease.</hc_freetext>
      <i_freetext>Intervention 1: In intervention group , the patients will receive remifentanil  as  the sole agent anesthetic  with doses : 4-8  µg/kg    ,and  the suuccynilcholine will administerd  for relaxation.The patients will ventilate by bag and mask  with 100% of oxygen till the bi-temporal  electrode will insert. The patients will observe in recovery until to fully awake position. Time of seizure and time of awakening also will record. All the patients are visited by psychiatrist to evaluated the   minimental status examination  before and 5 and 24 hours  after electro convulsive therapy. Intervention 2: In control group the patients will receive thiopental  4 mg/kg  with equal volume of  that prepare by normal saline. The patients will ventilated by bag and mask  with 100% of oxygen till the bi-temporal  electrode will insert. The patients will observe in recovery until to fully awake position. Time of seizure and time of awakening also will record. All the patients are visited by psychiatrist to evaluated the   (Mini Mental Status Exam )   MMSE     before and 5 and 24 hours  after electro convulsive therapy.</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>DrMohammad Haghighi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Poursina Hospital , Parastar.  St, /Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 13133323970</telephone>
        <email>MANESTHESIST@GMAIL.COM</email>
        <affiliation>Anesthesiology Research Center, Guilan University Of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Mohammad  Haghighi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Poursina Hospital, Parastar,St , Rasht.</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 13133323970</telephone>
        <email>MANESTHESIST@GMAIL.COM</email>
        <affiliation>Anesthesiology Research Center, Guilan University Of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: 60 patients between 18-60y; major depression; meet the DSM-TR IV ;. elective electroconvulsive therapy will performed only in 1th.&#13;
 The exclusion criteria : the patients with ASA class IV ; mild to moderate cognitive disorder;  emergency condition;  history of cardiovascular disease; mental retardation ;  uncontrolled hypertension.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32-3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Severe depressive episode with psychotic symptoms</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>In intervention group , the patients will receive remifentanil  as  the sole agent anesthetic  with doses : 4-8  µg/kg    ,and  the suuccynilcholine will administerd  for relaxation.The patients will ventilate by bag and mask  with 100% of oxygen till the bi-temporal  electrode will insert. The patients will observe in recovery until to fully awake position. Time of seizure and time of awakening also will record. All the patients are visited by psychiatrist to evaluated the   minimental status examination  before and 5 and 24 hours  after electro convulsive therapy.</i_keyword>
      <i_keyword>In control group the patients will receive thiopental  4 mg/kg  with equal volume of  that prepare by normal saline. The patients will ventilated by bag and mask  with 100% of oxygen till the bi-temporal  electrode will insert. The patients will observe in recovery until to fully awake position. Time of seizure and time of awakening also will record. All the patients are visited by psychiatrist to evaluated the   (Mini Mental Status Exam )   MMSE     before and 5 and 24 hours  after electro convulsive therapy.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cognitive Disorder after ECT. Timepoint: Before the ElectroConvulsive Therapy and 5 and 24 hours after ECT procedure. Method of measurement: MMSE  Questionnaire 24-30, no cognitive problem 23-18mild cognitive problem 0-17,sever cognitive problem.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Heart Rate. Timepoint: before  electro convulsive therapy /5 and  24 hour after  ECT. Method of measurement: ECG.</sec_outcome>
      <sec_outcome>Blood Presssure. Timepoint: the  time  before  electro convulsive therapy /5 and  24 hour after  ECT. Method of measurement: NonInvasive Blood Pressure .</sec_outcome>
      <sec_outcome>Seizure Duration . Timepoint: before  electro convulsive therapy /5 and  24 hour after  ECT. Method of measurement: By chronometer.</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, Guilan  University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-06-21</approval_date>
        <contact_name>Ethics committee of Guilan  University of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshti Highway Rasht  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
