<?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>IRCT20191025045235N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-13</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Comparative study effect of Dexmedetomidine and Ketamine on post operative analgesia after laparoscopic cholecystectomy</public_title>
      <acronym></acronym>
      <scientific_title>the Comparative study effect of Dexmedetomidine and Ketamine on post operative analgesia after laparoscopic cholecystectomy surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>252</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74152</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: People were divided into two groups completely randomly based on the random block permutation method. For example, for blocks of four, we imagined 6 blocks ABBA, AABB, ABAB, BABA, BBAA, BAAB, which should be n/4 We sampled from these blocks in the form of placement. The random sequence was obtained from the website www.sealedenevelope.com.
Patients are entered in the order of entry.Patients are randomly divided into three groups (ketamine, dexmedetomidine and control).Group: K In this group, 0.5 mg/kg/h of ketamine (Panpharma, Germany) is injected intravenously 15 minutes before surgical incision.
Group: D In this group, 0.6 µ/kg/min dexmedetomidine (Exir Company, Iran) is injected intravenously 15 minutes before surgical incision, Blinding description: the patient and the anesthesia technician are unware of the type of injected drug.the medicine is already prepare and given to the technician.</study_design>
      <phase>3</phase>
      <hc_freetext>cholesystit.</hc_freetext>
      <i_freetext>Intervention group:Patients are randomly divided into three groups (ketamine, dexmedetomidine and control). Group K: In this group, 0.5 mg/kg/h of ketamine (Panpharma, Germany) is injected intravenously 15 minutes before surgical incision. Group D: In this group, 0.6 µ/kg/min of dexmedetomidine (Exir Company, Iran) is injected intravenously 15 minutes before surgical incision. Group C: In this group, normal saline is injected intravenously..</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Only part of the data, such as information about the main outcome or the like, can be shared.

When:
The access period starts 6 months after the results are published

To whom:
It will be available only to researchers working in academic and scientific institutions.

Conditions:
Researcher's request to conduct similar studies

Where to obtain:
Request by sending an email to the responsible administrator

How to obtain:
Sending an email to the responsible executive and explaining the procedure, then sending the data to her

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyedeh Fatemeh Hosseininejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Hospital,Azadegan Ave,Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135913441</zip>
        <telephone>+98 916 615 2270</telephone>
        <email>drhosseininejad@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyedeh Fatemeh Hosseininejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Hospital,Azadegan Ave,Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135913441</zip>
        <telephone>+98 916 615 2270</telephone>
        <email>drhosseininejad@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patients with ASA class I and II
patients age between 18 and 50 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>emergency surgery
sensitivity to the drugs used in the study
abuse or alcohol
lack of consent to participate in the study
sychiatric disorder
patients who, for some reason, changed their operation from laparoscopic during surgery. The surgery is open.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G89.18</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other acute postprocedural pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Patients are randomly divided into three groups (ketamine, dexmedetomidine and control). Group K: In this group, 0.5 mg/kg/h of ketamine (Panpharma, Germany) is injected intravenously 15 minutes before surgical incision. Group D: In this group, 0.6 µ/kg/min of dexmedetomidine (Exir Company, Iran) is injected intravenously 15 minutes before surgical incision. Group C: In this group, normal saline is injected intravenously.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: 1-2-4-6 hours after the surgery. Method of measurement: After visiting the operating room and initial examinations, all patients will have an intravenous line with an 18 size angioket. Initial monitoring will include pulse oximetry, non-invasive sphygmomanometer, and electrocardiography. Initial symptoms will be recorded and treated with midazolam 0.03 drugs. mg/kg, fentanyl 2 µgr/kg, sodium thiopental 5 mg/kg and atracurium 0.5 mg/kg are placed under anesthesia induction and then intubated,They are connected to a ventilator and are anesthetized with isoflurane 1 ml during the operation and 0.1 mg/kg morphine is given to reduce pain during the operation. The patients are randomly divided into three groups (ketamine, dexmedetomidine and control). Group K: 15 minutes before surgical incision, 0.5 mg/kg/h of ketamine (Panpharma, Germany) is injected intravenously. Group D: In this group, 15 minutes before surgical incision, 0.6 µ/kg/min of dexmedetomidine (Exir, Iran) is injected into It is injected intravenously.Group C: In this group, normal saline is injected intravenously. Primary hemodynamic parameters such as heart rate and blood pressure are recorded upon arrival, immediately after receiving the study drugs, every 5 minutes to 15 minutes, and every 15 minutes until the end of the procedure. Next, the hemodynamic parameters and duration of painlessness, VAS score will be recorded at 24, 12, 6, 1 hours after the operation. 0 no pain), up to (VAS=10, the worst type of pain after surgery). If the score is higher than 3 after the surgery, painkillers will be prepared and injected (morphine 2-3 mg).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure and heart rate changes. Timepoint: Every 15 minutes during operation. Method of measurement: With pressure gauge and monitoring device.</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 Jundishapur University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-12</approval_date>
        <contact_name>Ethics committee of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Imam Khomeini Hospital,Azadegan Ave,Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
