<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01677351</url>
  </required_header>
  <id_info>
    <org_study_id>CEP 0609/01-clonidine</org_study_id>
    <nct_id>NCT01677351</nct_id>
  </id_info>
  <brief_title>Assessment of the Effect of Clonidine for Cataract Surgery</brief_title>
  <official_title>Assessment of the Effect of Clonidine on Pain, Arterial and Intraocular Pressure and Arrhythmias for Cataract Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of São Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of São Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clonidine, an agonist for alfa2 pre-synaptic, has been shown to be an effective adjuvant&#xD;
      therapy for acute postoperative pain and has been shown an effect in sedative, intra-ocular&#xD;
      and blood pressure and arrhythmias.The objective of this study is evaluating the analgesic&#xD;
      effect of clonidine and its repercussion on arterial and intraocular pressure and arrhythmias&#xD;
      for cataract surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After approved by the Ethical Committee and signed informed consent, 40 patients aged from 40&#xD;
      until 80 years undergoing cataract extraction will be randomized in two groups. Exclusion&#xD;
      criteria will be myocardial ischemia, psychiatric disease, chronic pain, drugs dependency,&#xD;
      chronic use of beta-blockage channel drugs. Group 2, patients will receive a single dose of&#xD;
      4mcg.kg-1 of clonidin2, 20 minutes before the surgical incision; group 1, patients will&#xD;
      receive a sterile saline solution dose. Pain intensity will be assessed with the numeric&#xD;
      rating scale. The antiarrythmic effect will be assessed with the continuous measure by&#xD;
      Holter. The number of patients was calculated by Instat Graph® program. To detect difference&#xD;
      in pain intensity of 3 between the groups by NRS, with 95% of power (estimated SD= 2.0), when&#xD;
      the alpha level is set at 0.05, the sample should be of 20. Statistical analyses will be&#xD;
      performed with parametric and nonparametric tests, considering the variety studied. The&#xD;
      statistical program that will be utilized is Instat Graph®.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2011</start_date>
  <completion_date type="Anticipated">December 2012</completion_date>
  <primary_completion_date type="Anticipated">September 2012</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>intensity of pain</measure>
    <time_frame>30 minutes before surgery, during the surgery</time_frame>
    <description>Pain intensity will be assessed by numeric rating scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>intraocular pressure</measure>
    <time_frame>30 minutes and during the surgery</time_frame>
    <description>Intra-ocular pressure will be assessed with a manual tonometer of perkins.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>antiarrythmic effect</measure>
    <time_frame>30 minutes before surgery and during the surgery</time_frame>
    <description>The antiarrythmic effect will be assessed with the continuous measure by Holter.</description>
  </other_outcome>
  <other_outcome>
    <measure>blood pressure</measure>
    <time_frame>30 minutes before and during the surgery</time_frame>
    <description>Blood pressure will be monitorized with a multiparameter monitor, a non-invasive measure.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Pain</condition>
  <condition>Arrythmia</condition>
  <arm_group>
    <arm_group_label>group 2: clonidine 4mcg.kg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>this group (group 2) will receive 4mcg.kg-1 of clonidine 20 minutes before surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 1: sterile saline solution</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>this group (Group 1) will receive a sample injection of sterile saline solution 20 minutes before surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clonidine</intervention_name>
    <description>4 mcg.kg-1, 20 minutes before cataract surgery</description>
    <arm_group_label>group 2: clonidine 4mcg.kg</arm_group_label>
    <other_name>cataract surgery</other_name>
    <other_name>anesthesic drugs</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>Group 1: sterile saline solution</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  cataract surgery&#xD;
&#xD;
          -  topical anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  myocardial ischemia&#xD;
&#xD;
          -  psychiatric disease&#xD;
&#xD;
          -  chronic pain&#xD;
&#xD;
          -  drugs dependency&#xD;
&#xD;
          -  use of beta-blockage channel drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rioko K Sakata, Study Chair</last_name>
    <role>Study Chair</role>
    <affiliation>Federal University of Sao Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Federal University of Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ana Ellen Santiago, investigator</last_name>
      <phone>55 1 69 9334 4747</phone>
      <email>ellensantiago@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Ana Ellen Santiago, investigator</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 1, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>August 31, 2012</last_update_submitted>
  <last_update_submitted_qc>August 31, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 3, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of São Paulo</investigator_affiliation>
    <investigator_full_name>Ana Ellen de Queiroz Santiago</investigator_full_name>
    <investigator_title>medical resident, principal investigator</investigator_title>
  </responsible_party>
  <keyword>clonidine</keyword>
  <keyword>cataract surgery</keyword>
  <keyword>arrythmia</keyword>
  <keyword>anesthesic medication</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clonidine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01677351
org study id: CEP 0609/01-clonidine
nct id: NCT01677351
lead sponsor: 
has dmc: Yes
Clonidine, an agonist for alfa2 pre-synaptic, has been shown to be an effective adjuvant
      therapy for acute postoperative pain and has been shown an effect in sedative, intra-ocular
      and blood pressure and arrhythmias.The objective of this study is evaluating the analgesic
      effect of clonidine and its repercussion on arterial and intraocular pressure and arrhythmias
      for cataract surgery.
After approved by the Ethical Committee and signed informed consent, 40 patients aged from 40
      until 80 years undergoing cataract extraction will be randomized in two groups. Exclusion
      criteria will be myocardial ischemia, psychiatric disease, chronic pain, drugs dependency,
      chronic use of beta-blockage channel drugs. Group 2, patients will receive a single dose of
      4mcg.kg-1 of clonidin2, 20 minutes before the surgical incision; group 1, patients will
      receive a sterile saline solution dose. Pain intensity will be assessed with the numeric
      rating scale. The antiarrythmic effect will be assessed with the continuous measure by
      Holter. The number of patients was calculated by Instat Graph® program. To detect difference
      in pain intensity of 3 between the groups by NRS, with 95% of power (estimated SD= 2.0), when
      the alpha level is set at 0.05, the sample should be of 20. Statistical analyses will be
      performed with parametric and nonparametric tests, considering the variety studied. The
      statistical program that will be utilized is Instat Graph®.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: intensity of pain
time frame: 30 minutes before surgery, during the surgery
description: Pain intensity will be assessed by numeric rating scale.
measure: intraocular pressure
time frame: 30 minutes and during the surgery
description: Intra-ocular pressure will be assessed with a manual tonometer of perkins.
measure: antiarrythmic effect
time frame: 30 minutes before surgery and during the surgery
description: The antiarrythmic effect will be assessed with the continuous measure by Holter.
measure: blood pressure
time frame: 30 minutes before and during the surgery
description: Blood pressure will be monitorized with a multiparameter monitor, a non-invasive measure.
arm group label: group 2: clonidine 4mcg.kg
arm group type: Active Comparator
description: this group (group 2) will receive 4mcg.kg-1 of clonidine 20 minutes before surgery.
arm group label: Group 1: sterile saline solution
arm group type: Placebo Comparator
description: this group (Group 1) will receive a sample injection of sterile saline solution 20 minutes before surgery
intervention type: Drug
intervention name: Clonidine
description: 4 mcg.kg-1, 20 minutes before cataract surgery
arm group label: group 2: clonidine 4mcg.kg
other name: cataract surgery
other name: anesthesic drugs
intervention type: Drug
intervention name: placebo
arm group label: Group 1: sterile saline solution
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Rioko K Sakata, Study Chair
role: Study Chair
affiliation: Federal University of Sao Paulo
facility: 
status: Recruiting
contact: 
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of São Paulo
investigator full name: Ana Ellen de Queiroz Santiago
investigator title: medical resident, principal investigator
mesh term: Cataract
mesh term: Arrhythmias, Cardiac
mesh term: Clonidine