<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/NCT03005665</url>
  </required_header>
  <id_info>
    <org_study_id>10055/PG-2Trg/2014/24258-59</org_study_id>
    <nct_id>NCT03005665</nct_id>
  </id_info>
  <brief_title>Effect of Acetazolamide on Optic Nerve Sheath Diameter in Laparoscopic Donor Nephrectomies</brief_title>
  <official_title>Effect of Orogastric Acetazolamide on Intraocular Pressure in Laparoscopic Donor Nephrectomies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Postgraduate Institute of Medical Education and Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Postgraduate Institute of Medical Education and Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the trial is to study the effect of acetazolamide administered via Ryle's tube&#xD;
      on optic nerve sheath diameter in laparoscopic live donor nephrectomy patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      this study was done on 40 American Society of Anaesthesiologist(ASA) I &amp; II live donors of&#xD;
      either sex in adult age group undergoing laparoscopic live donor nephrectomy. After getting&#xD;
      approval from institutes ethical committee and written informed consent, Donors were randomly&#xD;
      allocated to either of two group. Anaesthesia was induced with injection morphine 0.1 mg/kg,&#xD;
      injection propofol 1-2 mg/kg and vecuronium 0.1 mg/kg. Maintenance of anaesthesia was done&#xD;
      with isoflurane and oxygen. After induction donors were placed into modified flank position&#xD;
      with left side upward. Donors in Group A received Acetazolamide 5 mg/kg via orogastric tube&#xD;
      soon after the induction of anaesthesia. Group S received saline as a placebo. investigator&#xD;
      and subjects were blinded till the statistical analysis. Optic nerve sheath diameter was&#xD;
      measured six times during perioperative periods by using high frequency ultrasound probe.&#xD;
      Intra operative monitoring was done for Heart rate, Blood Pressure, pulse oximetry(Spo2), End&#xD;
      Tidal Carbon Dioxide(ETCO2), Train Of Four(TOF) and Bi spectral index(BIS). Post operatively&#xD;
      donors were reversed with injection neostigmine and glycopyrrolate.&#xD;
&#xD;
      once return of spontaneous ventilation was well established and patient becomes conscious&#xD;
      oriented trachea was extubated and donors were shifted to post anaesthetic care unit(PACU).&#xD;
      Postoperatively donors were monitored for Heart rate, Blood Pressure, Spo2, Comfort Score,&#xD;
      Visual analog score for incisional site pain and shoulder tip pain, and Post operative nausea&#xD;
      vomiting. Rescue analgesia was given to patients having comfort score less than 6.&#xD;
&#xD;
      After completion of study Optic nerve sheath diameter, pain scores and comfort scores was&#xD;
      compared between both groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Optic nerve sheath diameter being assessed</measure>
    <time_frame>baseline, 5 minutes, 10 minutes, 60 minutes, 120 minutes, 5 minutes post surgery</time_frame>
    <description>optic nerve sheath diameter measured during perioperative period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual analog score for incision site and shoulder pain</measure>
    <time_frame>baseline, 30 minutes, 60 minutes, 4 Hours, 12 hours, 24 Hours, 48 hours, 72 Hours.</time_frame>
    <description>visual analog score will be monitored postoperatively</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Intracranial Pressure Increase</condition>
  <arm_group>
    <arm_group_label>Group A - Acetazolamide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acetazolamide 5 mg/kg diluted in 10 ml normal saline through orogastric Ryle's Tube soon after the induction of anaesthesia followed by 10 ml normal saline flush.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group s - Normal saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>20 ml normal saline total volume.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetazolamide</intervention_name>
    <arm_group_label>Group A - Acetazolamide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal Saline</intervention_name>
    <arm_group_label>Group s - Normal saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of either gender&#xD;
&#xD;
          -  18-60 years of age&#xD;
&#xD;
          -  Hemodynamically stable patients.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient's refusal.&#xD;
&#xD;
          -  Ocular Defects/ Wounds /Previous ocular surgery.&#xD;
&#xD;
          -  H/O Hypertension&#xD;
&#xD;
          -  Patients having Double Renal Arteries.&#xD;
&#xD;
          -  Laparoscopic Nephrectomies converted to Open Surgeries&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ashish S Aditya, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>PGIMER, chandigarh, INDIA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>PGIMER</name>
      <address>
        <city>Chandigarh</city>
        <zip>160012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 24, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>December 24, 2016</last_update_submitted>
  <last_update_submitted_qc>December 24, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Postgraduate Institute of Medical Education and Research</investigator_affiliation>
    <investigator_full_name>Dr. Ashish Singh Aditya</investigator_full_name>
    <investigator_title>JUNIOR RESIDENT</investigator_title>
  </responsible_party>
  <keyword>optic nerve sheath diameter</keyword>
  <keyword>acetazolamide</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetazolamide</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/NCT03005665
org study id: 10055/PG-2Trg/2014/24258-59
nct id: NCT03005665
lead sponsor: 
has dmc: No
The purpose of the trial is to study the effect of acetazolamide administered via Ryle's tube
      on optic nerve sheath diameter in laparoscopic live donor nephrectomy patients.
this study was done on 40 American Society of Anaesthesiologist(ASA) I & II live donors of
      either sex in adult age group undergoing laparoscopic live donor nephrectomy. After getting
      approval from institutes ethical committee and written informed consent, Donors were randomly
      allocated to either of two group. Anaesthesia was induced with injection morphine 0.1 mg/kg,
      injection propofol 1-2 mg/kg and vecuronium 0.1 mg/kg. Maintenance of anaesthesia was done
      with isoflurane and oxygen. After induction donors were placed into modified flank position
      with left side upward. Donors in Group A received Acetazolamide 5 mg/kg via orogastric tube
      soon after the induction of anaesthesia. Group S received saline as a placebo. investigator
      and subjects were blinded till the statistical analysis. Optic nerve sheath diameter was
      measured six times during perioperative periods by using high frequency ultrasound probe.
      Intra operative monitoring was done for Heart rate, Blood Pressure, pulse oximetry(Spo2), End
      Tidal Carbon Dioxide(ETCO2), Train Of Four(TOF) and Bi spectral index(BIS). Post operatively
      donors were reversed with injection neostigmine and glycopyrrolate.

      once return of spontaneous ventilation was well established and patient becomes conscious
      oriented trachea was extubated and donors were shifted to post anaesthetic care unit(PACU).
      Postoperatively donors were monitored for Heart rate, Blood Pressure, Spo2, Comfort Score,
      Visual analog score for incisional site pain and shoulder tip pain, and Post operative nausea
      vomiting. Rescue analgesia was given to patients having comfort score less than 6.

      After completion of study Optic nerve sheath diameter, pain scores and comfort scores was
      compared between both groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Change in Optic nerve sheath diameter being assessed
time frame: baseline, 5 minutes, 10 minutes, 60 minutes, 120 minutes, 5 minutes post surgery
description: optic nerve sheath diameter measured during perioperative period
measure: Visual analog score for incision site and shoulder pain
time frame: baseline, 30 minutes, 60 minutes, 4 Hours, 12 hours, 24 Hours, 48 hours, 72 Hours.
description: visual analog score will be monitored postoperatively
arm group label: Group A - Acetazolamide
arm group type: Experimental
description: Acetazolamide 5 mg/kg diluted in 10 ml normal saline through orogastric Ryle's Tube soon after the induction of anaesthesia followed by 10 ml normal saline flush.
arm group label: Group s - Normal saline
arm group type: Placebo Comparator
description: 20 ml normal saline total volume.
intervention type: Drug
intervention name: Acetazolamide
arm group label: Group A - Acetazolamide
intervention type: Drug
intervention name: Normal Saline
arm group label: Group s - Normal saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ashish S Aditya, MD
role: Principal Investigator
affiliation: PGIMER, chandigarh, INDIA
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Postgraduate Institute of Medical Education and Research
investigator full name: Dr. Ashish Singh Aditya
investigator title: JUNIOR RESIDENT
mesh term: Intracranial Hypertension
mesh term: Acetazolamide