<?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>IRCT2016022126685N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-06-04</date_registration>
      <primary_sponsor>Ahvaz Jundishapur University Of Medical Sciences, Ahvaz, Iran</primary_sponsor>
      <public_title>The effect of intravenous Magnesium Sulfate versus an analgesic on the duration of Spinal anesthesia and post-operative pain in patients with leg fracture.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of intravenous Magnesium Sulfate versus intravenous Sufentanil on the duration of Spinal anesthesia and post-operative pain in patients with leg fracture.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-07-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Other</recruitment_status>
      <url>https://irct.ir/trial/22044</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>leg fracture.</hc_freetext>
      <i_freetext>Intervention 1: control group: In the second group, 8mg/kg/h Magnesium sulfate(10% Intravenous), in a quite similar way, should be diluted in 1liter of ringer and after an hour, after ensuring about the completion of anesthesia, Infusion will be done. All the patients were under spinal anesthesia, with 10 mg of Bupivacaine(10%), In a sitting position, with the needle no. 25 and  by Selecting the L4-L5 space and Nvragzyal block and failure to understand the sharpness of the needle in T10 dermatom, Patients are undergoing a  surgery. After the Spinal anesthesia and During the surgery with five minutes Intervals, Systolic and diastolic blood pressure, The percentage of arterial oxygen and heart rate are monitored and If blood pressure decreases by twenty percent or Systolic blood pressure decreases to less than 100mmHg, they will receive  Afrdyn (0.5mg), and If blood pressure decreases to less than 60, they will receive Atropine(0.5mg), The dose will be repeated, If needed.  As well, all the patients, during the surgery, will receive Oxygen 4 liters per minute. In this study, Onset of anesthesia will be evaluated with Pin Prick way and also, Patients  interview about heavy and tingling legs. Complete muscular weakness of lower extremity, following the Spinal Anesthesia, Is considered as a starting for point motor block and the duration of the anesthesia, will be evaluated with the Modified bromage scale. In this way, an hour after the start of operation, the sensory and motor block Condition will be evaluated by examining the normal feet and this evaluation will be continued and recorded an interval of every half an hour, by the end of the return of sensory and motor block recovery. Postoperative pain, will be evaluated by Visual Analog Scale(VAS). After the surgery, All the patients are transferred to recovery and until the end of returning from anesthesia, they will be monitored In terms of heart rate, breathing, the amount of oxygen saturation and also blood pressure. Patients' demographic characteristics are collected, such as; weight, age, gender, height and the length of surgery. Considering the end time of anesthesia in recovery, as the origin of Postoperative pain, after  0, 1, 4, 8, 16, 24 hours, compared to the end of anesthesia has been evaluated and registered and in the case of equal VAS (or more than 3), the patients will receive 30 mg/kg Pethidine intravenously. At the end, the first time of requesting analgesic and also, total analgesic consumption, will be recorded. Intervention 2: Intervention group: After embedding Peripheral venous cannula, we infused 10 cc/kg of Ringer crystalloid to the patients. All the patients were under spinal anesthesia, with 10 mg of Bupivacaine(10%), In a sitting position, with the needle no. 25 and  by Selecting the L4-L5 space and Nvragzyal block and failure to understand the sharpness of the needle in T10 dermatom, Patients are undergoing a surgery.&#13;
In the group which receives Sufentanil, in the group which receives sufentanil,  0.1 kg/h/µ of this Substance should be diluted in 1liter of ringer and after an hour, after ensuring about the completion of anesthesia, Infusion will be done.      &#13;
 In all participants, Serum levels of creatinine will be measured before the surgery and after the end of surgery, Patients are moved to the recovery room. &#13;
After the Spinal anesthesia and During the surgery with five minutes Intervals, Systolic and diastolic blood pressure, The percentage of arterial oxygen and heart rate are monitored and If blood pressure decreases by twenty percent or Systolic blood pressure decreases to less than 100mmHg, they will receive  Afrdyn (0.5mg), and If blood pressure decreases to less than 60, they will receive Atropine(0.5mg), The dose will be repeated, If needed.  As well, all the patients, during the surgery, will receive Oxygen 4 liters per minute. In this study, Onset of anesthesia will be evaluated with Pin Prick way and also, Patients  interview about heavy and tingling legs. Complete muscular weakness of lower extremity, following the Spinal Anesthesia, Is considered as a starting for point motor block and the duration of the anesthesia, will be evaluated with the Modified bromage scale. In this way, an hour after the start of operation, the sensory and motor block Condition will be evaluated by examining the normal feet and this evaluation will be continued and recorded an interval of every half an hour, by the end of the return of sensory and motor block recovery. Postoperative pain, will be evaluated by Visual Analog Scale(VAS). After the surgery, All the patients are transferred to recovery and until the end of returning from anesthesia, they  will be monitored In terms of heart rate, breathing, the amount of oxygen saturation and also blood pressure. Patients' demographic characteristics are collected, such as; weight, age, gender, height and the length of surgery. Considering the end time of anesthesia in recovery, as the origin of Postoperative pain, after  0, 1, 4, 8, 16, 24 hours, compared to the end of anesthesia has been evaluated and registered and in the case of equal VAS (or more than 3), the patients will receive 30 mg/kg Pethidine intravenously. At the end, the first time of requesting analgesic and also, total analgesic consumption, will be recorded.</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>Mahdis vakili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapur University Of Medical Sciences, Golestan Ave.</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 613367543</telephone>
        <email>mahdisvakili@yahoo.com</email>
        <affiliation>Ahvaz Jundishapur University Of Medical Sciences, Ahvaz, Iran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Jafari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Hospital, Sharif zadeh St,  Azadegan Ave.</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 914 104 2809</telephone>
        <email>mryamjafari59@yahoo.commahdisvakili@yahoo.com</email>
        <affiliation>Imam Khomeini Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Entry requirements; the age group of 18 to 58 years,  ASA I,II, BMI: 19-30 &#13;
&#13;
Exclusion criteria: Patient refusal; High ICP;  Coagulopathy; Skin infection, in the insertion of the needle; Peripheral neuropathy of the lower extremities; Drug and alcohol abuse; Using sedative and antipsychotic drugs and also psychotropic substances; Using calcium channel blockers; Having a history of mental illnesses and also Thyroid Disorders; A history of kidney disorders and cardiac arrhythmias.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>58 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S82.7</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple fractures of lower leg</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>control group: In the second group, 8mg/kg/h Magnesium sulfate(10% Intravenous), in a quite similar way, should be diluted in 1liter of ringer and after an hour, after ensuring about the completion of anesthesia, Infusion will be done. All the patients were under spinal anesthesia, with 10 mg of Bupivacaine(10%), In a sitting position, with the needle no. 25 and  by Selecting the L4-L5 space and Nvragzyal block and failure to understand the sharpness of the needle in T10 dermatom, Patients are undergoing a  surgery. After the Spinal anesthesia and During the surgery with five minutes Intervals, Systolic and diastolic blood pressure, The percentage of arterial oxygen and heart rate are monitored and If blood pressure decreases by twenty percent or Systolic blood pressure decreases to less than 100mmHg, they will receive  Afrdyn (0.5mg), and If blood pressure decreases to less than 60, they will receive Atropine(0.5mg), The dose will be repeated, If needed.  As well, all the patients, during the surgery, will receive Oxygen 4 liters per minute. In this study, Onset of anesthesia will be evaluated with Pin Prick way and also, Patients  interview about heavy and tingling legs. Complete muscular weakness of lower extremity, following the Spinal Anesthesia, Is considered as a starting for point motor block and the duration of the anesthesia, will be evaluated with the Modified bromage scale. In this way, an hour after the start of operation, the sensory and motor block Condition will be evaluated by examining the normal feet and this evaluation will be continued and recorded an interval of every half an hour, by the end of the return of sensory and motor block recovery. Postoperative pain, will be evaluated by Visual Analog Scale(VAS). After the surgery, All the patients are transferred to recovery and until the end of returning from anesthesia, they will be monitored In terms of heart rate, breathing, the amount of oxygen saturation and also blood pressure. Patients' demographic characteristics are collected, such as; weight, age, gender, height and the length of surgery. Considering the end time of anesthesia in recovery, as the origin of Postoperative pain, after  0, 1, 4, 8, 16, 24 hours, compared to the end of anesthesia has been evaluated and registered and in the case of equal VAS (or more than 3), the patients will receive 30 mg/kg Pethidine intravenously. At the end, the first time of requesting analgesic and also, total analgesic consumption, will be recorded.</i_keyword>
      <i_keyword>Intervention group: After embedding Peripheral venous cannula, we infused 10 cc/kg of Ringer crystalloid to the patients. All the patients were under spinal anesthesia, with 10 mg of Bupivacaine(10%), In a sitting position, with the needle no. 25 and  by Selecting the L4-L5 space and Nvragzyal block and failure to understand the sharpness of the needle in T10 dermatom, Patients are undergoing a surgery.&#13;
In the group which receives Sufentanil, in the group which receives sufentanil,  0.1 kg/h/µ of this Substance should be diluted in 1liter of ringer and after an hour, after ensuring about the completion of anesthesia, Infusion will be done.      &#13;
 In all participants, Serum levels of creatinine will be measured before the surgery and after the end of surgery, Patients are moved to the recovery room. &#13;
After the Spinal anesthesia and During the surgery with five minutes Intervals, Systolic and diastolic blood pressure, The percentage of arterial oxygen and heart rate are monitored and If blood pressure decreases by twenty percent or Systolic blood pressure decreases to less than 100mmHg, they will receive  Afrdyn (0.5mg), and If blood pressure decreases to less than 60, they will receive Atropine(0.5mg), The dose will be repeated, If needed.  As well, all the patients, during the surgery, will receive Oxygen 4 liters per minute. In this study, Onset of anesthesia will be evaluated with Pin Prick way and also, Patients  interview about heavy and tingling legs. Complete muscular weakness of lower extremity, following the Spinal Anesthesia, Is considered as a starting for point motor block and the duration of the anesthesia, will be evaluated with the Modified bromage scale. In this way, an hour after the start of operation, the sensory and motor block Condition will be evaluated by examining the normal feet and this evaluation will be continued and recorded an interval of every half an hour, by the end of the return of sensory and motor block recovery. Postoperative pain, will be evaluated by Visual Analog Scale(VAS). After the surgery, All the patients are transferred to recovery and until the end of returning from anesthesia, they  will be monitored In terms of heart rate, breathing, the amount of oxygen saturation and also blood pressure. Patients' demographic characteristics are collected, such as; weight, age, gender, height and the length of surgery. Considering the end time of anesthesia in recovery, as the origin of Postoperative pain, after  0, 1, 4, 8, 16, 24 hours, compared to the end of anesthesia has been evaluated and registered and in the case of equal VAS (or more than 3), the patients will receive 30 mg/kg Pethidine intravenously. At the end, the first time of requesting analgesic and also, total analgesic consumption, will be recorded.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sensory and motor block. Timepoint: An hour after the begining  the operation. Method of measurement: Modified Bromage Scale.</prim_outcome>
      <prim_outcome>Pain. Timepoint: After the  surgery. Method of measurement: Visual Analog Scale.</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 Jundishapur University Of Medical Sciences, Ahvaz, Iran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-02-13</approval_date>
        <contact_name>Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran</contact_name>
        <contact_address>Ahvaz Jondishapoor University of Medical Sciences, Golestan Ave. Ahvaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
