<?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>IRCT20151107024909N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-11</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of muscle relaxant dose of cis-atracurium based on body fat mass (FFM), total body weight (TBW) and ideal body weight (IBW) in patients undergoing obesity surgery.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of muscle relaxant dose of cis-atracurium based on body fat mass (FFM), total body weight (TBW) and ideal body weight (IBW) in patients undergoing obesity surgery.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45892</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done using identical envelopes, each envelope containing the name of one of the groups under study. These envelopes are available to patients who are candidates for bariatric surgery. They fall into one of three study groups (FFM - TBW - IBW) based on their envelope. According to the inclusion and exclusion criteria, 60 patients were finally selected for the study, Blinding description: Patients are divided into study groups using the same prepared envelopes and none of the patients are aware of the assigned group.</study_design>
      <phase>3</phase>
      <hc_freetext>Obesity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1:In the first group, the dose of cis atracurium was injected based on body fat mass (FFM) and changed during the dose of the drug based on the patient's hemodynamic status. It is categorized as non-dollarized. It is used in the anesthesia process for intubation and relaxation of skeletal muscle to facilitate surgery as well as mechanical ventilation of the patient. Cis atracurium is categorized by time of action except for moderate to effective medications. Ampoule concentration is 2 mg / ml, 2.5 ml and manufactured by the Daruyab company. Intervention 2: Intervention group2: In the second group, the dose of cisatracurium is injected based on total body weight (TBW) and changes in the dose of the drug are based on the patient's hemodynamic status during surgery.It is categorized as non-dollarized. It is used in the anesthesia process for intubation and relaxation of skeletal muscle to facilitate surgery as well as mechanical ventilation of the patient. Cis atracurium is categorized by time of action except for moderate to effective medications. Ampoule concentration is 2 mg / ml, 2.5 ml and manufactured by the Daruyab company. Intervention 3: Intervention group: In the third group, the dose of cisatracurium is injected based on ideal body weight (IBW) and changes in the dose of the drug are based on the patient's hemodynamic status during surgery.It is categorized as non-dollarized. It is used in the anesthesia process for intubation and relaxation of skeletal muscle to facilitate surgery as well as mechanical ventilation of the patient. Cis atracurium is categorized by time of action except for moderate to effective medications. Ampoule concentration is 2 mg / ml, 2.5 ml and manufactured by the Daruyab company.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Faranak Rokhtabnak</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 14 , Dejamjo Ave., Kamranieh Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>553406080050</zip>
        <telephone>+98 21 8871 7272</telephone>
        <email>rolhtabnak.f@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Faranak Rokhtabnak</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 14 , Dejamjo Ave., Kamranieh Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>553406080050</zip>
        <telephone>+98 21 8871 7272</telephone>
        <email>rolhtabnak.f@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ages 18 to 60
Patients with physical level below 3 according to the American Society of Anesthesiologists classification
BMI greater than ²35 kg / m
Normal kidney and liver function confirmed by routine screening tests</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy                                                                           ,
Neuromuscular Disease
Treatment with Well-known Interventions in Muscle Neurotransmission
Psychological Disorder
Allergy to Cis-atracurium
Criteria for Difficult Intubation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Overweight and obesity</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>Intervention group1:In the first group, the dose of cis atracurium was injected based on body fat mass (FFM) and changed during the dose of the drug based on the patient's hemodynamic status. It is categorized as non-dollarized. It is used in the anesthesia process for intubation and relaxation of skeletal muscle to facilitate surgery as well as mechanical ventilation of the patient. Cis atracurium is categorized by time of action except for moderate to effective medications. Ampoule concentration is 2 mg / ml, 2.5 ml and manufactured by the Daruyab company.</i_keyword>
      <i_keyword>Intervention group2: In the second group, the dose of cisatracurium is injected based on total body weight (TBW) and changes in the dose of the drug are based on the patient's hemodynamic status during surgery.It is categorized as non-dollarized. It is used in the anesthesia process for intubation and relaxation of skeletal muscle to facilitate surgery as well as mechanical ventilation of the patient. Cis atracurium is categorized by time of action except for moderate to effective medications. Ampoule concentration is 2 mg / ml, 2.5 ml and manufactured by the Daruyab company.</i_keyword>
      <i_keyword>Intervention group: In the third group, the dose of cisatracurium is injected based on ideal body weight (IBW) and changes in the dose of the drug are based on the patient's hemodynamic status during surgery.It is categorized as non-dollarized. It is used in the anesthesia process for intubation and relaxation of skeletal muscle to facilitate surgery as well as mechanical ventilation of the patient. Cis atracurium is categorized by time of action except for moderate to effective medications. Ampoule concentration is 2 mg / ml, 2.5 ml and manufactured by the Daruyab company.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Duration of muscle relaxation. Timepoint: During surgery. Method of measurement: Minutes.</prim_outcome>
      <prim_outcome>Dose of Cisatracurium. Timepoint: During surgery. Method of measurement: Mg, syringe.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Need for antagonism. Timepoint: During surgery and after surgery. Method of measurement: Mg, syringe.</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 Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-21</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>No. 14 , Dejamjo Ave., Kamranieh Town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
