<?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>IRCT20170314033069N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-12</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>The effect of lidocaine on wakefulness during general anesthesia in elective cesarean section</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of intravenous lidocaine on awareness during elective cesarean  section under general anesthesia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72498</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be randomized by a random sequence created in blocks of four by computer (Win Pepi 11.65 software). An anesthesiologist who has not participated in the project, through the list of eligible patients who gave informed consent and the sequence of randomization blocks in a ratio of 1:1  will assign patients to one of the two groups of lidocaine or placebo, Blinding description: This study is double-blind. The patient and the evaluator (trained medical student) who conducts the interview are unaware of the treatment groups. The drugs will be prepared in similar syringes by the anesthetist technician, who is not aware of the plan's goals and will be provided to the anesthesiologist so that the difference between the two cannot be identified. The responsible anesthetist technician present in the operating room is aware of the groups so that in case of complications, he will provide the necessary information for the anesthesiologist to perform the necessary intervention.</study_design>
      <phase>3</phase>
      <hc_freetext>Effect of intravenous lidocaine on awareness during general anesthesia for elective cesarean section.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the lidocaine group, before induction of anesthesia, 1 milligram per kilogram intravenous lidocaine 2% (100 milligram/5 milliliter, Aburaihan Pharmaceutical Company, Iran) will be injected. Intervention 2: Control group: In the placebo group, the same volume (1 milligram per kilogram) of normal saline will be injected.</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>Dr Gelareh Biazar</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 3332 9524</telephone>
        <email>gelarehbiazar1386@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Gelareh Biazar</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 3332 9524</telephone>
        <email>gelarehbiazar1386@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pregnant women candidates for caesarean section surgery under general anesthesia
American Society of Anesthesiologists (ASA) II, I
Hemodynamically stable condition</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Inability to communicate appropriately verbally to fill out the questionnaire
sensitivity to local amide acetic acid
Any contraindications to the use of ondansetron (heart problems, especially Long Q-T)
Contraindications to Apotel (liver failure)
Contraindications to propofol (including drug-food allergies)
Contraindications to lidocaine, including heart blocks (bradydysrhythmias)
The presence of any psychiatric disorder that interferes with answering the questions.
A history of malignant hyperthermia that prohibits the use of inhaled gases and succinylcholine.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R41.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other symptoms and signs involving cognitive functions and awareness</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the lidocaine group, before induction of anesthesia, 1 milligram per kilogram intravenous lidocaine 2% (100 milligram/5 milliliter, Aburaihan Pharmaceutical Company, Iran) will be injected.</i_keyword>
      <i_keyword>Control group: In the placebo group, the same volume (1 milligram per kilogram) of normal saline will be injected.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The effectiveness of lidocaine on the frequency of different states of the first memory after regaining consciousness. Timepoint: 24 hours after surgery. Method of measurement: Face-to-face interview.</prim_outcome>
      <prim_outcome>The effectiveness of lidocaine on the frequency of different states of the last memory before anesthesia of patients. Timepoint: 24 hours after surgery. Method of measurement: Face-to-face interview.</prim_outcome>
      <prim_outcome>The effectiveness of lidocaine on the frequency of different conditions related to awareness during anesthesia. Timepoint: 24 hours after surgery. Method of measurement: Face-to-face interview.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The effect of lidocaine on hemodynamic changes of patients (mean blood pressure and heart rate of the patient). Timepoint: 4 stations: base time (before injection of lidocaine), after intubation, end of operation, and after extubation. Method of measurement: Blood pressure and heart rate monitoring of patients.</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>2023-08-23</approval_date>
        <contact_name>Ethics committee 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>
