<?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>IRCT2013091414656N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-10-15</date_registration>
      <primary_sponsor>Kurdistan University of Medical Sciences</primary_sponsor>
      <public_title>Influence of drugs pethidine and morphine in prevention of shivering after anesthesia in women undergoing cesarean section</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of preventive effects of intrathecal  pethidine and morphine on post spinal anesthesia shivering in patients undergoing elective cesarean section</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14222</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Inclusion criteria for patients who have 60 patients in two groups of 30 each in a randomized block (Block 6 persons) are located. The 25% incidence of shivering in patients undergoing spinal anesthesia are, and taking into account the 80% of power. Alpha equal to 05/0 for a sample size of 28 patients per group was calculated to increase the accuracy of the results of 30 patients in each group (n = 60) was promoted.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Shivering after spinal anesthesia.</hc_freetext>
      <i_freetext>Intervention 1: First, all persons entering the operating room for elective caesarean section in a registration form are numbered. Then, based on the criteria of inclusion and exclusion criteria of inclusion and exclusion criteria and if give informed consent to participate in research, are filed in Form No. 2.If you have exclusion criteria, number one, because it will be mentioned in the same form.Randvmyzyshn and referred to by the same anesthetic technicians will perform their work and involvement in the assessment will not only prepare the drug.The participants will be divided into two groups of 30 patients by the statistical and methodological consultant to anesthesia technician.Essential drugs list based on a statistical consultant to the technicians, producers and labels on individual numbers are labeled. The drug is administered by an anesthesiologist.Group A and Group B pethidine to morphine 10 mg of 2/0 mg with 5/12 mg bupivacaine Hyprbar 5/0%, spinal needle is injected into the subarachnoid space,Site of needle insertion, number of attempts to find the subarachnoid space is recorded by an anesthesiologist then supine status of the patient has been injected fluid variables, spinal anesthetic is injected with the drug.Any complications during the surgery and recovery if it is administered. Measurements will be performed by an anesthesiologist. Intervention 2: The control group consisted of 30 people who are either on the same criteria entry and exit in the intervention group had been selected.The difference between the control group and the drug pethidine and morphine as the prevention of spinal anesthesia shivering are not used just the patient undergo spinal anesthesia by bupivacaine then all variables were recorded in the forum like 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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Erfan Khezripour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>plaque75- lane ansar7- kurdistan avenue- sanandaj</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6616733463</zip>
        <telephone>+98 87 1324 0787</telephone>
        <email>erfan.khezripour@muk.ac.ir</email>
        <affiliation>Kurdistan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Karim Naseri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>, Opposite the hotel Shadi,  Pasdaran avenue -</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6617713446</zip>
        <telephone>+98 87 1666 4646</telephone>
        <email>bihoshi@gmail.com</email>
        <affiliation>Kurdistan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The study population consisted of patients for elective cesarean section is referring to the operating room Besat Hospital in Sanandaj city.&#13;
Inclusion criteria: - candidate for elective caesarean section - fill the consent form to participate in the study - physical status class I or II according to the American Society of Anesthesia&#13;
Exclusion Criteria: - contraindications to spinal anesthesia - patients with valvular heart disease - pulmonary hypertension - diabetes - preeclampsia - eclampsia - Sepsis - Emergency situations - Lumbar Spine Disorders</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>074.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other complications of spinal and epidural anaesthesia during labour and delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First, all persons entering the operating room for elective caesarean section in a registration form are numbered. Then, based on the criteria of inclusion and exclusion criteria of inclusion and exclusion criteria and if give informed consent to participate in research, are filed in Form No. 2.If you have exclusion criteria, number one, because it will be mentioned in the same form.Randvmyzyshn and referred to by the same anesthetic technicians will perform their work and involvement in the assessment will not only prepare the drug.The participants will be divided into two groups of 30 patients by the statistical and methodological consultant to anesthesia technician.Essential drugs list based on a statistical consultant to the technicians, producers and labels on individual numbers are labeled. The drug is administered by an anesthesiologist.Group A and Group B pethidine to morphine 10 mg of 2/0 mg with 5/12 mg bupivacaine Hyprbar 5/0%, spinal needle is injected into the subarachnoid space,Site of needle insertion, number of attempts to find the subarachnoid space is recorded by an anesthesiologist then supine status of the patient has been injected fluid variables, spinal anesthetic is injected with the drug.Any complications during the surgery and recovery if it is administered. Measurements will be performed by an anesthesiologist.</i_keyword>
      <i_keyword>The control group consisted of 30 people who are either on the same criteria entry and exit in the intervention group had been selected.The difference between the control group and the drug pethidine and morphine as the prevention of spinal anesthesia shivering are not used just the patient undergo spinal anesthesia by bupivacaine then all variables were recorded in the forum like intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intensity of shivering after spinal anesthesia. Timepoint: After the intervention, the patient was awake in the recovery room to the exit from the operating room. Method of measurement: Evaluation standards for patient access time of discharge from chill out and chill duration and intensity based segmentation is based on 4 minutes scores is madeZero: no chills. Grade: mild fasciculation in the face and neck. Grade: trembling visible muscle groups in more than one category. Grade III: the major muscular activity involving the entire body.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Medication side effects (nausea, vomiting, nystagmus, hypotension requiring treatment, bradycardia requiring medication). Timepoint: Immediately after the surgical intervention. Method of measurement: based on observation of Anesthesiologists in the operating room and recovery room based on the observation of Anesthesia Technician.</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>Kurdistan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-09-22</approval_date>
        <contact_name>Kurdistan University of Medical Sciences</contact_name>
        <contact_address>, Opposite the hotel Shadi,  Pasdaran avenue - Sanandaj  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
