<?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>IRCT20210222050463N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-26</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effects of melatonin, vitamin C and oral clonidine on the patient's hemodynamic response during anesthesia and afterwards to pain in septorhinoplasty surgery.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effect of Oral Melatonin, Vitamin C and Clonidine on the Hemodynamic Response to Endotracheal Intubation, Anesthetic Requirements and Pain after Septorhinoplasty</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70843</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: . Using a table of random numbers generated by the computer, eligible patients will be randomly divided into three groups: melatonin (M group), vitamin C (C group) and clonidine (Cl group) and allocation concealment using envelopes. sealed matte will be done. Both the patient and the researcher will be unaware of the type of drug. The patients in the melatonin group received two tablets (3 mg each), the patients in the vitamin C group received two tablets (1 g each), and the patients in the clonidine group also received two tablets (0.1 mg each) 120 minutes before induction of anesthesia. will do The study drugs in all three groups will be the same in terms of size and color and will be given to the patient by the nursing staff in the ward.</study_design>
      <phase>3</phase>
      <hc_freetext>Determining the effect of oral melatonin, vitamin C and clonidine on the hemodynamic response to laryngoscopy and endotracheal intubation, the need for anesthetics and pain after septorhinoplasty..</hc_freetext>
      <i_freetext>Intervention group:.</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 Undecided - It is not yet known if there will be a plan to make this available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Noushin Sarvi Sarmeidani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahwaz University of Medical Sciences</address>
        <city>ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6143975617</zip>
        <telephone>+98 61 3390 6395</telephone>
        <email>nooshinsarvi9192@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Noushin Sarvi Sarmeidani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahwaz University of Medical Sciences</address>
        <city>ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6143975617</zip>
        <telephone>+98 61 3390 6395</telephone>
        <email>nooshinsarvi9192@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The age group is 18-40 years
Physical status I-II American Society of Anesthesiology
Candidate for general anesthesia and endotracheal intubationCommunity Verified icon</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Physical status III and above American Society of Anesthesiology
History of cognitive and mental disorders (dementia, severe depression)Community Verified icon
Patients who take anti-anxiety, sedative, anti-psychotic or anti-epileptic drugs.
History of circadian rhythm disorders such as chronic fatigue syndrome and sleepiness
History of chronic pain syndromes
Body mass index more than 30 kg/m²
History of difficult airway (Cormack Lehan grade [1] 2 or higher) or more than one intubation attemptCommunity Verified icon
History of obstructive sleep apnea and severe asthmaCommunity Verified icon
History of drug or alcohol abuse
History of congestive heart failure, heart block or bradycardia
History of liver or kidney failure
History of allergic reaction to studied drugsCommunity Verified icon
Patients who have difficulty communicating.Community Verified icon
If the patient moves during laryngoscopy or intubation.Community Verified icon</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Determining the effect of melatonin, vitamin C and oral clonidine on hemodynamic response. Timepoint: Continuously at baseline (T0), 120 minutes after study drug administration, upon entering the operating room (T1), after induction of anesthesia (T2), just before laryngoscopy and endotracheal intubation (T3), after Intubation at intervals of 1 minute (T4), 3 minutes (T5), 5 minutes (T6), 10 minutes (T7) and 15 minutes (T8). Method of measurement: Operating room monitoring device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Reducing the use of anesthetics and postoperative painCommunity Verified icon. Timepoint: During and after the operation. Method of measurement: VAS.</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>Research committee of Ahvaz Jundishapur university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-13</approval_date>
        <contact_name>Ethics Committee of Ahwaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Ahwaz Jundishapur University of Medical Sciences ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
