<?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>IRCT20120801010471N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-14</date_registration>
      <primary_sponsor>Sanandaj University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Dexmedetomidine on postoperative shivering after general anesthesia for  appendectomy</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Dexmedetomidine on postoperative shivering after general anesthesia for  appendectomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35341</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: Simple randomization, Blinding description: The personnel that fulfill the questionnaire , nurse,anesthesiologist, data analysand did not know the patients.</study_design>
      <phase>3</phase>
      <hc_freetext>Shivering after appendectomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Fentanyl 2µ/kg as a premedication, Thiopental sodium:5mg/kg and succinylcholin: 1.5mg/kg as induction of anesthesia were administered. Maintenance of anesthesia consists of Isoflurane 1.3 VOL% plus N2O and oxygen in the same concentration (3 L/min). The operation room was similar in all of our patients. The environment  and checked for similar  light, environmental temperature, drugs and  liquids were kept in same rooms with same temperature.Intra venous fluid was infused 7cc/kg Ringer 5-7 minutes before induction of anesthesia. Pre oxygenation by 5-6 liter oxygen by anesthetic mask were done in all patients. Intra venous maintenance was 4cc/kg/h plus 3cc/kg instead of every milliliter of bleeding. Bleeding calculated by gathering the gases in the operation field and the blood in the suction bottle. Temperature was measured base on tympanic membrane temperature in at minutes baseline time,5,15,30,60 after induction of anesthesia.We monitored non invasive blood pressure, puls oximetery, EKG monitoring (lead 2). We administered 1µ/kg dexmedtomedin intravenously 20 minutes before induction of anesthesia during 10 minutes and slowly (1µ/kg diluted in 10cc streel water)in intervention group. Intervention 2: Control group: Fentanyl 2µ/kg as a premedication, thiopental.sodium:5mg/kg and succinylcholin: 1.5mg/kg as induction of anesthesia were administered. Maintenance of anesthesia consists of Isoflurane 1.3 VOL% plus N2O and oxygen in the same concentration (3 L/min).The operation room was similar in all of our patients. The environment, and checked for similar light, environmental temperature, drugs and  liquids were kept in same rooms with same temperature.Intra venous fluid was infused 7cc/kg Ringer 5-7 minutes before induction of anesthesia.pre oxygenation by 5-6 liter oxygen by anesthetic mask were done in all patients. Intra venous maintenance was 4cc/kg/h plus 3cc/kg instead of every milliliter of bleeding. Bleeding calculated by gathering the gases in the operation field and the blood in the suction bottle.Temperature was measured base on tympanic membrane temperature in at minutes baseline time,5,15,30,60 after induction of anesthesia.We monitored non invasive blood pressure, puls oximetery, EKG monitoring (lead 2).</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:
All the information in the article will be presented

When:
2020

To whom:
All people related to health

Conditions:
All people related to health

Where to obtain:
Milad Masaeli

How to obtain:
Email to Milad Masaeli and get it

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Milad Masaeli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kowsar hospital, Pasdaran Ave, Azadi Square</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>66177-13446</zip>
        <telephone>+98 87 3361 1310</telephone>
        <email>drmilmas@yahoo.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Milad Masaeli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kowsar hospital,Pasdaran Ave,Azadi Square</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>66177-13446</zip>
        <telephone>+98 87 3361 1310</telephone>
        <email>drmilmas@yahoo.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Emergent appendectomy patients</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>25 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with peritonitis
Past medical history of malignant hyperthermia
Seizure
Anaphylaxis
Cardiovascular disease
Diabetes mellitus
Renal disease
Substance use
Liver disease
Alcohol use
Anti epileptic agent use
Psychological disorders
NSAIDs and usage of any other opioids or drugs for decreasing pain
ASA more 2</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>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Fentanyl 2µ/kg as a premedication, Thiopental sodium:5mg/kg and succinylcholin: 1.5mg/kg as induction of anesthesia were administered. Maintenance of anesthesia consists of Isoflurane 1.3 VOL% plus N2O and oxygen in the same concentration (3 L/min). The operation room was similar in all of our patients. The environment  and checked for similar  light, environmental temperature, drugs and  liquids were kept in same rooms with same temperature.Intra venous fluid was infused 7cc/kg Ringer 5-7 minutes before induction of anesthesia. Pre oxygenation by 5-6 liter oxygen by anesthetic mask were done in all patients. Intra venous maintenance was 4cc/kg/h plus 3cc/kg instead of every milliliter of bleeding. Bleeding calculated by gathering the gases in the operation field and the blood in the suction bottle. Temperature was measured base on tympanic membrane temperature in at minutes baseline time,5,15,30,60 after induction of anesthesia.We monitored non invasive blood pressure, puls oximetery, EKG monitoring (lead 2). We administered 1µ/kg dexmedtomedin intravenously 20 minutes before induction of anesthesia during 10 minutes and slowly (1µ/kg diluted in 10cc streel water)in intervention group.</i_keyword>
      <i_keyword>Control group: Fentanyl 2µ/kg as a premedication, thiopental.sodium:5mg/kg and succinylcholin: 1.5mg/kg as induction of anesthesia were administered. Maintenance of anesthesia consists of Isoflurane 1.3 VOL% plus N2O and oxygen in the same concentration (3 L/min).The operation room was similar in all of our patients. The environment, and checked for similar light, environmental temperature, drugs and  liquids were kept in same rooms with same temperature.Intra venous fluid was infused 7cc/kg Ringer 5-7 minutes before induction of anesthesia.pre oxygenation by 5-6 liter oxygen by anesthetic mask were done in all patients. Intra venous maintenance was 4cc/kg/h plus 3cc/kg instead of every milliliter of bleeding. Bleeding calculated by gathering the gases in the operation field and the blood in the suction bottle.Temperature was measured base on tympanic membrane temperature in at minutes baseline time,5,15,30,60 after induction of anesthesia.We monitored non invasive blood pressure, puls oximetery, EKG monitoring (lead 2).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Shivering scale. Timepoint: Immediately after general anesthesia, 5, 15, 30, and 60 minutes after general anesthesia. Method of measurement: Shivering was evaluated using a 5-point scale. The scale used was;0 = no shivering; 1 = observation of one or more of the following: piloerection, peripheral vasoconstriction, peripheral cyanosis without other causes, and/or no visible muscular activity; 2 = visible muscular activity confined to 1 muscle group; 3 = visible muscular activity in more than 1 muscle group; 4 = gross muscular activity involving the entire body.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain Scale. Timepoint: 5,10,15,20. Method of measurement: Visual Analogue Scale.</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>Sanandaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-03-06</approval_date>
        <contact_name>Ethics Committee of Kurdistan University of Medical Sciences</contact_name>
        <contact_address>Pardis of Kurdistan University of Medical scinece, Pasdaran Ave, Azadi Square Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
