<?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>IRCT20220706055402N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-01</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>dexmedetomidine in colonoscopy</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of hemodynamic changes of dexmedetomidine in comparison with ketamine in patients undergoing colonoscopy under sedation with propofol</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64746</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the classification of the subjects is done by the four-point permutation block method.In this method, A represents the person who receives the intervention and B represents the person who is placed in the control group. Code 1, abba code 2, BAAB code 3, BBAA code 4 and BABA code 5 to 9. 21 Numbers are considered as rows or columns. 138 people will be divided into two groups, Blinding description: After selecting the samples, the participants in the study, the endoscopic physician and the principal investigator are not aware of the allocation method and the drugs are injected by an anesthesiologist who is aware of the allocation and the data collection is done by them.</study_design>
      <phase>3</phase>
      <hc_freetext>colonoscopy,sedation.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group will use propofol with a dose of 0.5 mg per kg and dexmedetomidine with a dose of 1 mg per kg and at a rate of 0.5 mg per kg per hour manufactured by Daro Farah Iran Company. Intervention 2: Intervention group: Propofol is given at a dose of 0.5 mg per kg and ketamine at a dose of 0.5 mg per kg.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is After the study will be determined</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Moftakhar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Hospital,Azadegan St,Ahwaz</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6193673111</zip>
        <telephone>+98 61 3338 3372</telephone>
        <email>moftakhar-f@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Moftakhar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Hospital,Azadegan St,Ahwaz</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6193673111</zip>
        <telephone>+98 61 3338 3372</telephone>
        <email>moftakhar-f@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The absence of cardiovascular diseases
The absence of kidney or liver failure diseases
absence of drug addiction
absence of contraindications to the use of dexmedetomidine, propofol
people which are classified in class 1 and 2 of the American Society of Anesthesiology (II, I class ASA) are selected.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness of the patient to participate in the study
intestinal perforation during procedure
bleeding of the esophagus or stomach or intestine during the procedure
changing the type of procedure during colonoscopy or requiring surgery during the procedure</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T88.52</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Failed moderate sedation during procedure</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>The intervention group will use propofol with a dose of 0.5 mg per kg and dexmedetomidine with a dose of 1 mg per kg and at a rate of 0.5 mg per kg per hour manufactured by Daro Farah Iran Company</i_keyword>
      <i_keyword>Intervention group: Propofol is given at a dose of 0.5 mg per kg and ketamine at a dose of 0.5 mg per kg.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Total amount of Propofol consumed. Timepoint: From start to end of colonoscopy. Method of measurement: Dose of drug.</prim_outcome>
      <prim_outcome>Level of sedation. Timepoint: From start to end of colonoscopy. Method of measurement: Ramsay Sedation Scale.</prim_outcome>
      <prim_outcome>Amount of pain. Timepoint: From start to one hour after colonoscopy. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Amount of Nausea and Vomiting. Timepoint: From start to end of colonoscopy. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Time of recovery. Timepoint: From start to end of colonoscopy. Method of measurement: From end of colonoscopy to full consciousness.</prim_outcome>
      <prim_outcome>Hemodynamic instability. Timepoint: From start to end of colonoscopy. Method of measurement: Amount of Heart rate, mean arterial pressure and blood oxygen saturation changes.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-21</approval_date>
        <contact_name>Ethics Committee of Golestan Educational-Research and Treatment Center of Ahvaz Jundishapur Universi</contact_name>
        <contact_address>Golestan hospital,Golestan Ave,Golestan town Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
