<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/NCT03016234</url>
  </required_header>
  <id_info>
    <org_study_id>VC16OISI0143</org_study_id>
    <nct_id>NCT03016234</nct_id>
  </id_info>
  <brief_title>IOP Changes With Different Anesthetic Agents During Laparoscopic Colorectal Surgery</brief_title>
  <official_title>Intraocular Pressure Changes During Laparoscopic Colorectal Surgery: Propofol Versus Desflurane Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saint Vincent's Hospital, Korea</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Saint Vincent's Hospital, Korea</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is aimed to evaluate how intraocular pressure (IOP) is changed depending on&#xD;
      surgical position (Trendelenburg versus reverse Trendelenburg) in the same patient and to&#xD;
      compare the effects of different anesthetics on IOP (desflurane versus propofol) in patients&#xD;
      undergoing laparoscopic colorectal surgery. The study design is a double-blind randomized&#xD;
      controlled trial. The patients were randomly assigned to desflurane or propofol administrated&#xD;
      groups and all patient are administered intravenous remifentanil continuously as adjuvant&#xD;
      analgesics during anesthesia. For this study 50 to 80-year-old patients undergoing&#xD;
      laparoscopic colorectal surgery without eye disease were enrolled. Mean arterial blood&#xD;
      pressure, peak airway pressure, end tidal carbon dioxide, and IOP (using a Tono-pen® Avia&#xD;
      tonometer) on both eyes were measured at defined intervals during the procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Perioperative visual loss is a rare but devastating complication associated with certain type&#xD;
      of operative procedures. Laparoscopic or robotic surgeries for colorectal cancer, prostate&#xD;
      cancer and diseases of the female genital organs in the pelvic cavity are performed in a&#xD;
      steep Trendelenburg position and pneumoperitoneum, which increases the intraocular pressure&#xD;
      (IOP) by 13-26 mmHg compared with the preoperative IOP value. High intraocular pressure is&#xD;
      believed to correlate with decreased perfusion to the optic nerve, and thus could lead to&#xD;
      ischemic optic neuropathy. The objective of the study is to test which anesthetic agent&#xD;
      (desflurane or propofol) can attenuate the changes in IOP during laparoscopic colorectal&#xD;
      surgery and identify correlated parameters. Fifty patients (30-80 years; American Society of&#xD;
      Anesthesiologists' physical status 1-2) scheduled for laparoscopic colorectal surgery will be&#xD;
      enrolled and allocated randomly into two groups (group D and group P). After measurement of&#xD;
      initial IOP with topical opthalmic anesthetics, general anesthesia will be induced with&#xD;
      pentothal sodium 5-6mg/kg (group D) or propofol (group P) 2-2.5mg/kg. After administration of&#xD;
      muscle relaxant and intubation, intraocular pressure will be measured and anesthesia will be&#xD;
      maintained with desflurane (group D) or propofol (group P) and all patients will be&#xD;
      administered intravenous remifentanil concurrently during anesthesia. During anesthesia, IOP&#xD;
      will be measured at different patient positions. At the time of each IOP measurements, the&#xD;
      following data set will be collected: mean arterial pressure (MAP), End tidal carbon dioxide&#xD;
      (EtCO2), peak inspiratory pressure (PIP).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 29, 2016</start_date>
  <completion_date type="Actual">March 8, 2017</completion_date>
  <primary_completion_date type="Actual">March 8, 2017</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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>changes in intraocular pressure (IOP) in different positions during laparoscopic colorectal surgery under desflurane or propofol anesthesia.</measure>
    <time_frame>before anesthesia induction, immediately after intubation, after pneumoperitoneum, 30 minutes after head down and right tilt position, 10 minutes after head up and right tilt, 30 minutes after head down and right tilt and 5 minutes before extubation</time_frame>
    <description>T1 (baseline: initial IOP before anesthesia induction), T2 (immediately after endotracheal intubation), T3(after pneumoperitoneum in supine position), T4 (30 minutes after position change to head down and right tilt), T5 (10 minutes after position change to head up and right tilt), T6 (30 minutes after position change to head down and right tilt) and T7 (5 minutes before endotracheal extubation)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes in mean arterial pressure (MAP) in different positions during laparoscopic colorectal surgery under desflurane or propofol anesthesia.</measure>
    <time_frame>before anesthesia induction, immediately after intubation, after pneumoperitoneum, 30 minutes after head down and right tilt position, 10 minutes after head up and right tilt, 30 minutes after head down and right tilt and 5 minutes before extubation</time_frame>
    <description>T1 (baseline: initial MAP before anesthesia induction), T2 (immediately after endotracheal intubation), T3(after pneumoperitoneum in supine position), T4 (30 minutes after position change to head down and right tilt), T5 (10 minutes after position change to head up and right tilt), T6 (30 minutes after position change to head down and right tilt) and T7 (5 minutes before endotracheal extubation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in end tidal carbon dioxide in different positions during laparoscopic colorectal surgery under desflurane or propofol anesthesia.</measure>
    <time_frame>immediately after intubation, after pneumoperitoneum, 30 minutes after head down and right tilt position, 10 minutes after head up and right tilt, 30 minutes after head down and right tilt and 5 minutes before extubation</time_frame>
    <description>T2 (immediately after endotracheal intubation), T3(after pneumoperitoneum in supine position), T4 (30 mins after position change to head down and right tilt), T5 (10 mins after position change to head up and right tilt), T6 (30 mins after position change to head down and right tilt) and T7 (5 minutes before endotracheal extubation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in peak airway pressure in different positions during laparoscopic colorectal surgery under desflurane or propofol anesthesia.</measure>
    <time_frame>immediately after intubation, after pneumoperitoneum, 30 minutes after head down and right tilt position, 10 minutes after head up and right tilt, 30 minutes after head down and right tilt and 5 minutes before extubation</time_frame>
    <description>T2 (immediately after endotracheal intubation), T3(after pneumoperitoneum in supine position), T4 (30 mins after position change to head down and right tilt), T5 (10 mins after position change to head up and right tilt), T6 (30 mins after position change to head down and right tilt) and T7 (5 minutes before endotracheal extubation)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Intraocular Pressure</condition>
  <arm_group>
    <arm_group_label>Desflurane</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>inhalation anesthesia administration for maintenance of anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Propofol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>intravenous anesthesia administration for maintenance of anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Desflurane</intervention_name>
    <description>On arrival in the operating room, initial intraocular pressure is measured after administration of alcaine 0.5% eye drop and routine monitoring and bispectral index(BIS) are applied. Anesthesia is induced with pentothal sodium inj (thiopental sodium 0.53g) 5-6mg/kg and esmeron inj (rocuronium bromide 50mg/5ml) 1mg/kg. Then endotracheal intubation is performed, anesthesia is maintained with 50% oxygen-air-4~7% desflurane inhalation and intravenous remifentanil continous infusion (effect site concentration 3-6ng/mL) during operation. Desflurane concentration is titrated to maintain BIS values within a target range 40-60 during operation. Mean arterial blood pressure, peak airway pressure, end tidal carbon dioxide, and IOP on both eyes are measured at defined intervals.</description>
    <arm_group_label>Desflurane</arm_group_label>
    <other_name>Suprane soln. 240ml/Bottle</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>On arrival in the operating room, initial intraocular pressure is measured after administration of alcaine 0.5% eye drop and routine monitoring and bispectral index(BIS) are applied. Anesthesia is induced with fresofol MCT 1% inj (1% propofol) 1.5-2.5mg/kg and esmeron inj (rocuronium bromide 50mg/5ml) 1mg/kg. Then endotracheal intubation is performed, anesthesia is maintained with intravenous fresofol MCT 2% inj (2% propofol, effect site concentration 2.5-5μg/mL) and remifentanil (effect site concentration 3-6ng/mL) continous infusion. Effect site concentration of propofol is titrated to maintain BIS values within a target range 40-60 during operation. Mean arterial blood pressure, peak airway pressure, end tidal carbon dioxide, and IOP on both eyes are measured at defined intervals.</description>
    <arm_group_label>Propofol</arm_group_label>
    <other_name>Fresofol medium-chain triglyceride (MCT) 2% inj. 50mL</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients undergoing laparoscopic colorectal surgery American society of&#xD;
             anesthesiologist physical status class I or II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  opthalmic disease or previously undergone opthalmic surgery, uncontrolled&#xD;
             hypertension, arrythmia, psychiatric disorder, uncontrolled obstructive lung disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kwon hui Seo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saint Vincent's Hospital, Korea</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saint Vincent's Hospital, Korea</name>
      <address>
        <city>Suwon</city>
        <state>Gyonggido</state>
        <zip>16247</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <results_reference>
    <citation>Joo J, Koh H, Lee K, Lee J. Effects of Systemic Administration of Dexmedetomidine on Intraocular Pressure and Ocular Perfusion Pressure during Laparoscopic Surgery in a Steep Trendelenburg Position: Prospective, Randomized, Double-Blinded Study. J Korean Med Sci. 2016 Jun;31(6):989-96. doi: 10.3346/jkms.2016.31.6.989. Epub 2016 Apr 6.</citation>
    <PMID>27247511</PMID>
  </results_reference>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>April 24, 2017</last_update_submitted>
  <last_update_submitted_qc>April 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Saint Vincent's Hospital, Korea</investigator_affiliation>
    <investigator_full_name>Seo, Kwon Hui</investigator_full_name>
    <investigator_title>Clinical Assistant Professor, Department of anesthesia and pain medicine, Saint Vincent's Hospital, Korea</investigator_title>
  </responsible_party>
  <keyword>intraocular pressure</keyword>
  <keyword>trendelenburg position</keyword>
  <keyword>pneumoperitoneum</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Desflurane</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03016234
org study id: VC16OISI0143
nct id: NCT03016234
lead sponsor: 
has dmc: No
This study is aimed to evaluate how intraocular pressure (IOP) is changed depending on
      surgical position (Trendelenburg versus reverse Trendelenburg) in the same patient and to
      compare the effects of different anesthetics on IOP (desflurane versus propofol) in patients
      undergoing laparoscopic colorectal surgery. The study design is a double-blind randomized
      controlled trial. The patients were randomly assigned to desflurane or propofol administrated
      groups and all patient are administered intravenous remifentanil continuously as adjuvant
      analgesics during anesthesia. For this study 50 to 80-year-old patients undergoing
      laparoscopic colorectal surgery without eye disease were enrolled. Mean arterial blood
      pressure, peak airway pressure, end tidal carbon dioxide, and IOP (using a Tono-pen® Avia
      tonometer) on both eyes were measured at defined intervals during the procedure.
Perioperative visual loss is a rare but devastating complication associated with certain type
      of operative procedures. Laparoscopic or robotic surgeries for colorectal cancer, prostate
      cancer and diseases of the female genital organs in the pelvic cavity are performed in a
      steep Trendelenburg position and pneumoperitoneum, which increases the intraocular pressure
      (IOP) by 13-26 mmHg compared with the preoperative IOP value. High intraocular pressure is
      believed to correlate with decreased perfusion to the optic nerve, and thus could lead to
      ischemic optic neuropathy. The objective of the study is to test which anesthetic agent
      (desflurane or propofol) can attenuate the changes in IOP during laparoscopic colorectal
      surgery and identify correlated parameters. Fifty patients (30-80 years; American Society of
      Anesthesiologists' physical status 1-2) scheduled for laparoscopic colorectal surgery will be
      enrolled and allocated randomly into two groups (group D and group P). After measurement of
      initial IOP with topical opthalmic anesthetics, general anesthesia will be induced with
      pentothal sodium 5-6mg/kg (group D) or propofol (group P) 2-2.5mg/kg. After administration of
      muscle relaxant and intubation, intraocular pressure will be measured and anesthesia will be
      maintained with desflurane (group D) or propofol (group P) and all patients will be
      administered intravenous remifentanil concurrently during anesthesia. During anesthesia, IOP
      will be measured at different patient positions. At the time of each IOP measurements, the
      following data set will be collected: mean arterial pressure (MAP), End tidal carbon dioxide
      (EtCO2), peak inspiratory pressure (PIP).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: changes in intraocular pressure (IOP) in different positions during laparoscopic colorectal surgery under desflurane or propofol anesthesia.
time frame: before anesthesia induction, immediately after intubation, after pneumoperitoneum, 30 minutes after head down and right tilt position, 10 minutes after head up and right tilt, 30 minutes after head down and right tilt and 5 minutes before extubation
description: T1 (baseline: initial IOP before anesthesia induction), T2 (immediately after endotracheal intubation), T3(after pneumoperitoneum in supine position), T4 (30 minutes after position change to head down and right tilt), T5 (10 minutes after position change to head up and right tilt), T6 (30 minutes after position change to head down and right tilt) and T7 (5 minutes before endotracheal extubation)
measure: changes in mean arterial pressure (MAP) in different positions during laparoscopic colorectal surgery under desflurane or propofol anesthesia.
time frame: before anesthesia induction, immediately after intubation, after pneumoperitoneum, 30 minutes after head down and right tilt position, 10 minutes after head up and right tilt, 30 minutes after head down and right tilt and 5 minutes before extubation
description: T1 (baseline: initial MAP before anesthesia induction), T2 (immediately after endotracheal intubation), T3(after pneumoperitoneum in supine position), T4 (30 minutes after position change to head down and right tilt), T5 (10 minutes after position change to head up and right tilt), T6 (30 minutes after position change to head down and right tilt) and T7 (5 minutes before endotracheal extubation)
measure: changes in end tidal carbon dioxide in different positions during laparoscopic colorectal surgery under desflurane or propofol anesthesia.
time frame: immediately after intubation, after pneumoperitoneum, 30 minutes after head down and right tilt position, 10 minutes after head up and right tilt, 30 minutes after head down and right tilt and 5 minutes before extubation
description: T2 (immediately after endotracheal intubation), T3(after pneumoperitoneum in supine position), T4 (30 mins after position change to head down and right tilt), T5 (10 mins after position change to head up and right tilt), T6 (30 mins after position change to head down and right tilt) and T7 (5 minutes before endotracheal extubation)
measure: changes in peak airway pressure in different positions during laparoscopic colorectal surgery under desflurane or propofol anesthesia.
time frame: immediately after intubation, after pneumoperitoneum, 30 minutes after head down and right tilt position, 10 minutes after head up and right tilt, 30 minutes after head down and right tilt and 5 minutes before extubation
description: T2 (immediately after endotracheal intubation), T3(after pneumoperitoneum in supine position), T4 (30 mins after position change to head down and right tilt), T5 (10 mins after position change to head up and right tilt), T6 (30 mins after position change to head down and right tilt) and T7 (5 minutes before endotracheal extubation)
arm group label: Desflurane
arm group type: Active Comparator
description: inhalation anesthesia administration for maintenance of anesthesia
arm group label: Propofol
arm group type: Active Comparator
description: intravenous anesthesia administration for maintenance of anesthesia
intervention type: Drug
intervention name: Desflurane
description: On arrival in the operating room, initial intraocular pressure is measured after administration of alcaine 0.5% eye drop and routine monitoring and bispectral index(BIS) are applied. Anesthesia is induced with pentothal sodium inj (thiopental sodium 0.53g) 5-6mg/kg and esmeron inj (rocuronium bromide 50mg/5ml) 1mg/kg. Then endotracheal intubation is performed, anesthesia is maintained with 50% oxygen-air-4~7% desflurane inhalation and intravenous remifentanil continous infusion (effect site concentration 3-6ng/mL) during operation. Desflurane concentration is titrated to maintain BIS values within a target range 40-60 during operation. Mean arterial blood pressure, peak airway pressure, end tidal carbon dioxide, and IOP on both eyes are measured at defined intervals.
arm group label: Desflurane
other name: Suprane soln. 240ml/Bottle
intervention type: Drug
intervention name: Propofol
description: On arrival in the operating room, initial intraocular pressure is measured after administration of alcaine 0.5% eye drop and routine monitoring and bispectral index(BIS) are applied. Anesthesia is induced with fresofol MCT 1% inj (1% propofol) 1.5-2.5mg/kg and esmeron inj (rocuronium bromide 50mg/5ml) 1mg/kg. Then endotracheal intubation is performed, anesthesia is maintained with intravenous fresofol MCT 2% inj (2% propofol, effect site concentration 2.5-5μg/mL) and remifentanil (effect site concentration 3-6ng/mL) continous infusion. Effect site concentration of propofol is titrated to maintain BIS values within a target range 40-60 during operation. Mean arterial blood pressure, peak airway pressure, end tidal carbon dioxide, and IOP on both eyes are measured at defined intervals.
arm group label: Propofol
other name: Fresofol medium-chain triglyceride (MCT) 2% inj. 50mL
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
last name: Kwon hui Seo, MD
role: Principal Investigator
affiliation: Saint Vincent's Hospital, Korea
facility: 
country: Korea, Republic of
citation: Joo J, Koh H, Lee K, Lee J. Effects of Systemic Administration of Dexmedetomidine on Intraocular Pressure and Ocular Perfusion Pressure during Laparoscopic Surgery in a Steep Trendelenburg Position: Prospective, Randomized, Double-Blinded Study. J Korean Med Sci. 2016 Jun;31(6):989-96. doi: 10.3346/jkms.2016.31.6.989. Epub 2016 Apr 6.
PMID: 27247511
responsible party type: Principal Investigator
investigator affiliation: Saint Vincent's Hospital, Korea
investigator full name: Seo, Kwon Hui
investigator title: Clinical Assistant Professor, Department of anesthesia and pain medicine, Saint Vincent's Hospital, Korea
mesh term: Propofol
mesh term: Desflurane
sharing ipd: No