<?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>IRCT20110425006280N14</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-11</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy and safety of two muscle relaxants cisatracurium and succinylcholine in Electroconvulsive therapy</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of efficacy and safety of two muscle relaxants cisatracurium and succinylcholine in Electroconvulsive therapy; A randomized, single-blind clinical trial study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>62</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70281</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into two groups by an anesthesia technician who does not participate in the project, using four random blocks created by the computer (Win Pepi 11.65 software). This is done through a list of eligible patients who have given informed consent. They will be assigned to one of the two groups receiving succinylcholine or cisatracurium by a sequence of randomization blocks in a 1: 1 ratio.
The output of the software consists of letters and numbers. The letters A and B indicate the under-study treatments (succinylcholine and cisatracurium) and the indicated numbers indicate the patients who will be assigned to the treatments consecutively, Blinding description: This study is a single-blinded study. In this way, the patient is blind, but due to the nature of the relaxant drugs and their different pharmacodynamics, including obvious and generalized fasciculation of succinylcholine, the evaluator (resident of anesthesiology) who fills out the checklist is aware of the treatment groups. The responsible anesthesiologist present in the shock department is also aware of the groups in order to perform the necessary intervention in case of complications (bradycardia, master spasm, ECG changes in favor of hyperkalemia, hemodynamic changes, and arterial blood oxygenation).</study_design>
      <phase>3</phase>
      <hc_freetext>Investigation of using cisatracurium instead of succinylcholine for anesthesia in electroshock therapy in cases that there is a contraindication for succinylcholine.</hc_freetext>
      <i_freetext>Intervention 1: first intervention group: Before receiving anesthesia and electroshock therapy, standard monitoring of non-invasive blood pressure, pulse oximetry, electrocardiogram, and end-tidal carbon dioxide will be established and atropine 0.5 milligrams will be prescribed. After establishing a proper intravenous cateter size 20-18, induction of anesthesia with propofol 1 miligrams/kilograms and cisatracurium 0.1 miligrams/kilograms will be prescribed. Intervention 2: Second intervention group: After establishing a proper venous catheter, induction of anesthesia with propel 1 milligrams/kilograms and succinylcholine 0.5 milligrams/kilograms will be prescribed.</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 Not decided yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Haghighi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Anesthesiology Research Center, Alzahra Hospital, Namjoo Street, Rasht, Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4144654839</zip>
        <telephone>+98 13 3211 1319</telephone>
        <email>manesthesist@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Haghighi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Anesthesiology Research Center, Alzahra Hospital, Namjoo Street, Rasht, Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4144654839</zip>
        <telephone>+98 13 3211 1319</telephone>
        <email>manesthesist@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients 18 years and older
ASA I,II
Normal body mass index
No criteria for difficult mask ventilation
No contraindication for cisatracurium and succinylcholine</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>myasthenia gravis
History of malignant hyperthermia
History of burns
Kidney failure
Guillain-Barré syndrome
Any nerve denervation
Dangerous arrhythmias</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T88.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other complications of anesthesia</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>first intervention group: Before receiving anesthesia and electroshock therapy, standard monitoring of non-invasive blood pressure, pulse oximetry, electrocardiogram, and end-tidal carbon dioxide will be established and atropine 0.5 milligrams will be prescribed. After establishing a proper intravenous cateter size 20-18, induction of anesthesia with propofol 1 miligrams/kilograms and cisatracurium 0.1 miligrams/kilograms will be prescribed.</i_keyword>
      <i_keyword>Second intervention group: After establishing a proper venous catheter, induction of anesthesia with propel 1 milligrams/kilograms and succinylcholine 0.5 milligrams/kilograms will be prescribed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Seizure duration. Timepoint: Momentary monitoring of colonic movements in the organ from the beginning of the seizure. Method of measurement: chronometer.</prim_outcome>
      <prim_outcome>Time of returning of the effective breaths of the patient. Timepoint: Momentary monitoring from the beginning of the seizure. Method of measurement: chronometer.</prim_outcome>
      <prim_outcome>Time of recovery. Timepoint: recovery time. Method of measurement: Observation.</prim_outcome>
      <prim_outcome>Patient discharge from recovery. Timepoint: Momentary monitoring to score 9 or 10. Method of measurement: Aldret score.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mean arterial blood pressure (MAP). Timepoint: Before injection, 1 minute after seizure and 15 minutes after induction of anesthesia. Method of measurement: Blood pressure measurement.</sec_outcome>
      <sec_outcome>Heart rate (pulse/ minute). Timepoint: Before injection, 1 minute after seizure and 15 minutes after induction of anesthesia. Method of measurement: Heart rate monitor.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-03</approval_date>
        <contact_name>Ethical Comeetee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for research, Shahid Siadati Avenue, Namjoo Street,Rasht Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
