<?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>IRCT20210415050976N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-22</date_registration>
      <primary_sponsor>Jahrom University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of ketamine and dexmedetomidine in maintenance anesthesia</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Ketamine and Dexmedetomidine in Maintenance of Anesthesia with Bispectral Index Scale during General Anesthesia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56167</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization method is used. With the help of the online site (www.sealedenvelope.com/simple-randomiser/v1/lists) randomization, 8 blocks of 15 are created. In each block, randomly classified, 5 patients are assigned to the ketamine group, 5 patients to the dexmedetomidine group, and 5 patients to the control group, Blinding description: For blinding, in the present study, the double-blind method is used so that the person reviewing the results and the person performing the injections do not know which patient received dexmethomedin and ketamine.</study_design>
      <phase>3</phase>
      <hc_freetext>General anesthesia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Dexmedetomidine infusion dose of 0.5 to 1 macro / kg body weight per hour will be administered during general anesthesia. The drug dexmedetomidine is used under the brand name Seddox, owned by Themis Medicare, and the vial of NDCC contains 200 micrograms of dexmedetomidine. Intervention 2: Intervention group 2: Ketamine infusion dose of 25. Up to 0.5 macro / kg body weight per hour will be administered during general anesthesia. Ketamine used is made by Pfizer company in Germany and its ampoule contains 10 cc of 500mg solution. Intervention 3: Control group: Simultaneously with anesthesia, a bolus dose of distilled water will be given as a placebo.</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 There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Navid Kalani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jahrom, Shahid Motahari Boulevard</address>
        <city>Jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7167758256</zip>
        <telephone>+98 71 2536 5231</telephone>
        <email>k.navid@jums.ac.ir</email>
        <affiliation>Jahrom University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Navid Kalani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jahrom, Shahid Motahari Boulevard 7167758256</address>
        <city>Jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7167758256</zip>
        <telephone>+98 71 2536 5231</telephone>
        <email>k.navid@jums.ac.ir</email>
        <affiliation>Jahrom University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being an NPO for 8 hours
ASA class one or two
Satisfaction with general anesthesia</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>High blood pressure
Severe cardiovascular disease
Severe dysfunction of the liver and kidneys</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>A21.7</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Generalized tularemia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Dexmedetomidine infusion dose of 0.5 to 1 macro / kg body weight per hour will be administered during general anesthesia. The drug dexmedetomidine is used under the brand name Seddox, owned by Themis Medicare, and the vial of NDCC contains 200 micrograms of dexmedetomidine.</i_keyword>
      <i_keyword>Intervention group 2: Ketamine infusion dose of 25. Up to 0.5 macro / kg body weight per hour will be administered during general anesthesia. Ketamine used is made by Pfizer company in Germany and its ampoule contains 10 cc of 500mg solution.</i_keyword>
      <i_keyword>Control group: Simultaneously with anesthesia, a bolus dose of distilled water will be given as a placebo.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depth of anesthesia. Timepoint: After induction of anesthesia by an observer until the end of anesthesia will continue every 15 minutes. Method of measurement: Cerebral State Monitor device made by Donmeter.dk company from Denmark and electrocardiographic electrodes will be used.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The pain. Timepoint: After surgery in recovery. Method of measurement: Pain is assessed according to the ruler criteria.</sec_outcome>
      <sec_outcome>Frequent nausea and vomiting. Timepoint: In recovery. Method of measurement: Based on the frequency of nausea and vomiting.</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>Jahrom University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-09</approval_date>
        <contact_name>Ethics Committee of Jahrom University of Medical Sciences</contact_name>
        <contact_address>Jahrom, Shahid Motahari Boulevard, Jahrom University of Medical Sciences, Vice Chancellor for Research Jahrom Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
