<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/NCT01676064</url>
  </required_header>
  <id_info>
    <org_study_id>0003-12-ZIV</org_study_id>
    <nct_id>NCT01676064</nct_id>
  </id_info>
  <brief_title>Influence of Perioperative Fluid Management on Intraocular Pressure During Hynecologic Laparoscopic Pelvic Surgery</brief_title>
  <official_title>Influence of Perioperative Fluid Management on Intraocular Pressure During Hynecologic Laparoscopic Pelvic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ziv Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ziv Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to quantify the Intraocular Pressure (IOP) changes in patients&#xD;
      undergoing laparoscopic hysterectomy at different time points and body positions throughout&#xD;
      the procedure, and to explore the influence of perioperative fluid management on the&#xD;
      fluctuations of IOP during perioperative period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <primary_completion_date type="Anticipated">August 2013</primary_completion_date>
  <phase>N/A</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>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>measurements of intraocular pressure during laparoscopic gynecologic surgery a sa function of diffrent perioperative fluid regimes.</measure>
    <time_frame>24 hr</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>IOP will be measured using a Tono-pen® XL by an ophthalmologist who will be unaware of the perioperative fluid administration regimen.</measure>
    <time_frame>24 hr</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Influence of Perioperative Fluid Regime on Intraocular Pressure During Laparoscopic Gynecologic Surgery</condition>
  <arm_group>
    <arm_group_label>liberal fluid group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>during surgery 7 ml/kg/hr RL during first intraoperative hr, 5 ml/kg/hr for the subsequent hours.After surgery ( PACU) 1,5 ml/kg/hr;After operation ward on the day of surgery 1,5 ml/kg/hr; Postoperative day 1- 1,5 ml/kg/hr RL, oral fluids;Postoperative day 2-oral fluids and solid food according to surgical allowance.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>restrictive fluid group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>during surgery-RL according to &quot;4-2-1&quot; 4 ml/kg/hr for first 10 kg (=40ml/hr) then 2 ml/kg/hr for next 10 kg (=20ml/hr)then 1 ml/kg/hr for any kg over 20 kg of weight. This always gives 60ml/hr for first 20 kg then you add 1 ml/kg/hr for each kg over 20 kg.&#xD;
After surgery (PACU):&quot;4-2-1&quot; rule. After operation ward on the day of surgery 1,5 ml/kg/hr.Postoperative day 1:1,5 ml/kg/hr RL, oral fluids. Postoperative day 2:oral fluids and solid food according to surgical allowance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ringer lactate solution</intervention_name>
    <arm_group_label>liberal fluid group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>restrictive fluid regime</intervention_name>
    <arm_group_label>restrictive fluid group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  50-60 adult female patients,&#xD;
&#xD;
          -  ASA physical status I or II,&#xD;
&#xD;
          -  scheduled for elective hynecologic laparoscopic pelvic surgery will be included in the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients will be excluded if they are &gt; 70 and &lt; 18 yr of age,&#xD;
&#xD;
          -  had have a body weight &gt; 150% of their ideal body weight,&#xD;
&#xD;
          -  have acute or chronic eye disease,&#xD;
&#xD;
          -  receive any medication known to alter IOP, or&#xD;
&#xD;
          -  have any mental illnesses.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sieff Medical Center</name>
      <address>
        <city>Zafed</city>
        <zip>13300</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 12, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>August 27, 2012</last_update_submitted>
  <last_update_submitted_qc>August 27, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 30, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>intraocular pressure</keyword>
  <keyword>perioperative fluid</keyword>
  <keyword>trendelenburg position</keyword>
  <keyword>laparoscopic gynecologic surgery</keyword>
  <!-- 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/NCT01676064
org study id: 0003-12-ZIV
nct id: NCT01676064
lead sponsor: 
has dmc: Yes
The aim of this study was to quantify the Intraocular Pressure (IOP) changes in patients
      undergoing laparoscopic hysterectomy at different time points and body positions throughout
      the procedure, and to explore the influence of perioperative fluid management on the
      fluctuations of IOP during perioperative period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: measurements of intraocular pressure during laparoscopic gynecologic surgery a sa function of diffrent perioperative fluid regimes.
time frame: 24 hr
measure: IOP will be measured using a Tono-pen® XL by an ophthalmologist who will be unaware of the perioperative fluid administration regimen.
time frame: 24 hr
arm group label: liberal fluid group
arm group type: Active Comparator
description: during surgery 7 ml/kg/hr RL during first intraoperative hr, 5 ml/kg/hr for the subsequent hours.After surgery ( PACU) 1,5 ml/kg/hr;After operation ward on the day of surgery 1,5 ml/kg/hr; Postoperative day 1- 1,5 ml/kg/hr RL, oral fluids;Postoperative day 2-oral fluids and solid food according to surgical allowance.
arm group label: restrictive fluid group
arm group type: Active Comparator
description: during surgery-RL according to "4-2-1" 4 ml/kg/hr for first 10 kg (=40ml/hr) then 2 ml/kg/hr for next 10 kg (=20ml/hr)then 1 ml/kg/hr for any kg over 20 kg of weight. This always gives 60ml/hr for first 20 kg then you add 1 ml/kg/hr for each kg over 20 kg.
After surgery (PACU):"4-2-1" rule. After operation ward on the day of surgery 1,5 ml/kg/hr.Postoperative day 1:1,5 ml/kg/hr RL, oral fluids. Postoperative day 2:oral fluids and solid food according to surgical allowance.
intervention type: Drug
intervention name: ringer lactate solution
arm group label: liberal fluid group
intervention type: Other
intervention name: restrictive fluid regime
arm group label: restrictive fluid group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Israel
responsible party type: Sponsor