<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/NCT02968082</url>
  </required_header>
  <id_info>
    <org_study_id>MVD</org_study_id>
    <nct_id>NCT02968082</nct_id>
  </id_info>
  <brief_title>The Effects of Preoperative Scopolamine Patch Application on the Postoperative Nausea and Vomiting in MVD Surgery</brief_title>
  <official_title>The Effects of Preoperative Scopolamine Patch Application on the Postoperative Nausea and Vomiting in Microvascular Decompression Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Single-center, randomized, prospective, experimental, double-blind comparison study for&#xD;
      effects of preoperative scopolamine patch application on the postoperative nausea and&#xD;
      vomiting in microvascular decompression surgery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Study design and plan&#xD;
&#xD;
           1-1) Sixty envelopes will be prepared: Thirty envelopes of scopolamine patch for&#xD;
           experimental group and 30 of placebo patch for control group. Each envelope will be&#xD;
           tagged for QR code, randomly mixed and numbered from 1 to 60. QR code will be identified&#xD;
           after discontinuation of study, so both researchers and subjects would not know in which&#xD;
           group the envelope is belonged to.&#xD;
&#xD;
           1-2) Patch will be applied under the ear of the opposite side of operation, at 9 p.m. of&#xD;
           the day before the operation day.&#xD;
&#xD;
           1-3) Nausea will be assessed by Visual Analogue Scale (VAS) immediate after arrival at a&#xD;
           recovery room and the ward. After that, nausea will be continuously assessed every 4&#xD;
           hour (4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery) and a number of vomiting will&#xD;
           also be counted. Basic clinical characteristics and the number of antiemetic&#xD;
           administration will be identified through medical records.&#xD;
&#xD;
        2. Efficacy assessment&#xD;
&#xD;
           2-1) Degree of nausea: Visual Analogue Scale (VAS) Subjects will describe their subject&#xD;
           degree of nausea by VAS score, just immediate after arrival at a recovery room or the&#xD;
           ward and 4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery. Respondents specify their&#xD;
           degree of nausea by indicating a point along a continuous 10cm line between two&#xD;
           end-points; left one is for &quot;No nausea&quot; and the right one for &quot;Very severe nausea&quot;.&#xD;
           Scoring is based on the length from left point and higher score means more severe degree&#xD;
           of nausea.&#xD;
&#xD;
           2-2) Number of vomiting Number of vomiting is counted from immediate after arrival at&#xD;
           recovery room or the ward, 4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after operation and will&#xD;
           be recorded. If there is no vomiting, it will be recorded as &quot;0&quot;.&#xD;
&#xD;
           2-3) Number of antiemetic administration It will be recorded from immediate after&#xD;
           arrival at recovery room or the ward, 4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after&#xD;
           operation. The kind of antiemetic used and the dosage or number of administration can be&#xD;
           identified through medical records.&#xD;
&#xD;
           2-4) Type of antiemetic and time of administration 2-4-1) PRN) Meckool 10mg/2ml 1amp IVs&#xD;
           When VAS is more than 5 or when subjects want at minimum interval of 6hour and maximum&#xD;
           of three times. If there is no improvement, it will be noticed.&#xD;
&#xD;
           2-4-2) PRC) Nasea 0.3mg 1amp IVs&#xD;
&#xD;
        3. Statistical plans&#xD;
&#xD;
           3-1) General characteristics and clinical characteristics will be analyzed by frequency,&#xD;
           percentage, mean value and standard deviation.&#xD;
&#xD;
           3-2) Homogeneity of variances between experimental group and control group will be&#xD;
           analyzed by Chi-square test, t-test and Fisher's exact test 3-3) Degree of nausea&#xD;
           between experimental group and control group at recovery room or the ward, 4hr, 8hr,&#xD;
           12hr, 16hr, 20hr, and 24hr after operation will be analyzed by Student's t-test.&#xD;
&#xD;
           3-4) Number of vomiting and antiemetic administration between experimental group and&#xD;
           control group will be analyzed by Fisher's exact test.&#xD;
&#xD;
           3-5) Hospitalization period between experimental group and control group will be&#xD;
           analyzed by Student's t-test.&#xD;
&#xD;
        4. Experimental group of scopolamine patch application will be expected to have less&#xD;
           severity of nausea and fewer numbers of vomiting or antiemetic usages. Ultimately, this&#xD;
           may relate to hospitalization period and it will be decreased.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">October 2017</completion_date>
  <primary_completion_date type="Anticipated">October 2017</primary_completion_date>
  <phase>Phase 4</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Degree of nausea: Visual Analogue Scale (VAS)</measure>
    <time_frame>just immediate after arrival at a recovery room or the ward and 4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery</time_frame>
    <description>Subjects will describe their subject degree of nausea by VAS score, just immediate after arrival at a recovery room or the ward and 4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery. Respondents specify their degree of nausea by indicating a point along a continuous 10cm line between two end-points; left one is for &quot;No nausea&quot; and the right one for &quot;Very severe nausea&quot;. Scoring is based on the length from left point and higher score means more severe degree of nausea.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Patients</condition>
  <arm_group>
    <arm_group_label>Placebo group (P group)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The group that not existed scopolamine ingredient.&#xD;
dosage form: apply&#xD;
dosage: 1.5 mg&#xD;
frequency: 1 times (at 9 p.m. of the day before the operation day)&#xD;
duration: Until the 24hr after operation.&#xD;
Patients will be applied patch that not existed scopolamine ingredient.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Scopolamine group (S group)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>'Scopolamine (1.5mg) 1 patch'&#xD;
The group that existed scopolamine ingredient&#xD;
dosage form: apply&#xD;
dosage: 1.5 mg&#xD;
frequency: 1 times (at 9 p.m. of the day before the operation day)&#xD;
duration: Until the 24hr after operation.&#xD;
Patients will be applied patch that existed scopolamine ingredient.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Scopolamine</intervention_name>
    <description>Patch will be applied under the ear of the opposite side of operation, at 9 p.m. of the day before the operation day. Nausea will be assessed by Visual Analogue Scale (VAS) immediate after arrival at a recovery room and the ward. After that, nausea will be continuously assessed every 4 hour (4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery) and a number of vomiting will also be counted. Basic clinical characteristics and the number of antiemetic administration will be identified through medical records.</description>
    <arm_group_label>Scopolamine group (S group)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Patch will be applied under the ear of the opposite side of operation, at 9 p.m. of the day before the operation day. Nausea will be assessed by Visual Analogue Scale (VAS) immediate after arrival at a recovery room and the ward. After that, nausea will be continuously assessed every 4 hour (4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery) and a number of vomiting will also be counted. Basic clinical characteristics and the number of antiemetic administration will be identified through medical records.</description>
    <arm_group_label>Placebo group (P group)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Those of either hemi-facial spasm or trigeminal neuralgia, who undergo microvascular&#xD;
             decompression (MVD), understand study objectives and voluntarily consent with&#xD;
             participation.&#xD;
&#xD;
          2. Adequate communication ability enough to understand and answer the questionnaire.&#xD;
&#xD;
          3. Age ≥ 18 years, and ≤ 65 years.&#xD;
&#xD;
          4. ASA Physical Status Classification from 1 to 2. Class 1: A normal healthy patient&#xD;
             Class 2: A patient with mild systemic disease&#xD;
&#xD;
          5. Those who is discharged to general ward, not intensive care unit (ICU) after operation&#xD;
&#xD;
          6. Normal liver or kidney function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. More than one craniotomy in the same period of admission&#xD;
&#xD;
          2. Pregnant or lactating women&#xD;
&#xD;
          3. Narrow-angle glaucoma&#xD;
&#xD;
          4. Pyloric stenosis, intestinal obstruction, bladder obstruction&#xD;
&#xD;
          5. Bradycardia&#xD;
&#xD;
          6. Voiding difficulty such as benign prostate hypertrophy (BPH)&#xD;
&#xD;
          7. Any history of hypersensitivity to ointment base or scopolamine patch&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jung Ho Han, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jung Ho Han, PhD</last_name>
    <phone>+82-31-787-7172</phone>
    <email>nstaus29@snubh.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Eun-Jin Choi</last_name>
    <phone>+82-31-787-7165</phone>
    <email>r0415@snubh.org</email>
  </overall_contact_backup>
  <reference>
    <citation>Sato K, Sai S, Adachi T. Is microvascular decompression surgery a high risk for postoperative nausea and vomiting in patients undergoing craniotomy? J Anesth. 2013 Oct;27(5):725-30. doi: 10.1007/s00540-013-1621-9. Epub 2013 May 7.</citation>
    <PMID>23649917</PMID>
  </reference>
  <reference>
    <citation>Pergolizzi JV Jr, Philip BK, Leslie JB, Taylor R Jr, Raffa RB. Perspectives on transdermal scopolamine for the treatment of postoperative nausea and vomiting. J Clin Anesth. 2012 Jun;24(4):334-45. doi: 10.1016/j.jclinane.2011.07.019.</citation>
    <PMID>22608591</PMID>
  </reference>
  <reference>
    <citation>Einarsson JI, Audbergsson BO, Thorsteinsson A. Scopolamine for prevention of postoperative nausea in gynecologic laparoscopy, a randomized trial. J Minim Invasive Gynecol. 2008 Jan-Feb;15(1):26-31. doi: 10.1016/j.jmig.2007.08.616.</citation>
    <PMID>18262140</PMID>
  </reference>
  <reference>
    <citation>Apfel CC, Zhang K, George E, Shi S, Jalota L, Hornuss C, Fero KE, Heidrich F, Pergolizzi JV, Cakmakkaya OS, Kranke P. Transdermal scopolamine for the prevention of postoperative nausea and vomiting: a systematic review and meta-analysis. Clin Ther. 2010 Nov;32(12):1987-2002. doi: 10.1016/j.clinthera.2010.11.014. Erratum In: Clin Ther. 2010 Dec;32(14):2502.</citation>
    <PMID>21118734</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 19, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>November 16, 2016</last_update_submitted>
  <last_update_submitted_qc>November 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jung Ho Han</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>MVD</keyword>
  <keyword>Scopolamine</keyword>
  <keyword>Microvascular Decompression</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vomiting</mesh_term>
    <mesh_term>Postoperative Nausea and Vomiting</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scopolamine</mesh_term>
    <mesh_term>Butylscopolammonium Bromide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>March 10, 2020</submitted>
    <returned>March 24, 2020</returned>
  </pending_results>
  <!-- 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/NCT02968082
org study id: MVD
nct id: NCT02968082
lead sponsor: 
has dmc: Yes
A Single-center, randomized, prospective, experimental, double-blind comparison study for
      effects of preoperative scopolamine patch application on the postoperative nausea and
      vomiting in microvascular decompression surgery
1. Study design and plan

           1-1) Sixty envelopes will be prepared: Thirty envelopes of scopolamine patch for
           experimental group and 30 of placebo patch for control group. Each envelope will be
           tagged for QR code, randomly mixed and numbered from 1 to 60. QR code will be identified
           after discontinuation of study, so both researchers and subjects would not know in which
           group the envelope is belonged to.

           1-2) Patch will be applied under the ear of the opposite side of operation, at 9 p.m. of
           the day before the operation day.

           1-3) Nausea will be assessed by Visual Analogue Scale (VAS) immediate after arrival at a
           recovery room and the ward. After that, nausea will be continuously assessed every 4
           hour (4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery) and a number of vomiting will
           also be counted. Basic clinical characteristics and the number of antiemetic
           administration will be identified through medical records.

        2. Efficacy assessment

           2-1) Degree of nausea: Visual Analogue Scale (VAS) Subjects will describe their subject
           degree of nausea by VAS score, just immediate after arrival at a recovery room or the
           ward and 4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery. Respondents specify their
           degree of nausea by indicating a point along a continuous 10cm line between two
           end-points; left one is for "No nausea" and the right one for "Very severe nausea".
           Scoring is based on the length from left point and higher score means more severe degree
           of nausea.

           2-2) Number of vomiting Number of vomiting is counted from immediate after arrival at
           recovery room or the ward, 4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after operation and will
           be recorded. If there is no vomiting, it will be recorded as "0".

           2-3) Number of antiemetic administration It will be recorded from immediate after
           arrival at recovery room or the ward, 4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after
           operation. The kind of antiemetic used and the dosage or number of administration can be
           identified through medical records.

           2-4) Type of antiemetic and time of administration 2-4-1) PRN) Meckool 10mg/2ml 1amp IVs
           When VAS is more than 5 or when subjects want at minimum interval of 6hour and maximum
           of three times. If there is no improvement, it will be noticed.

           2-4-2) PRC) Nasea 0.3mg 1amp IVs

        3. Statistical plans

           3-1) General characteristics and clinical characteristics will be analyzed by frequency,
           percentage, mean value and standard deviation.

           3-2) Homogeneity of variances between experimental group and control group will be
           analyzed by Chi-square test, t-test and Fisher's exact test 3-3) Degree of nausea
           between experimental group and control group at recovery room or the ward, 4hr, 8hr,
           12hr, 16hr, 20hr, and 24hr after operation will be analyzed by Student's t-test.

           3-4) Number of vomiting and antiemetic administration between experimental group and
           control group will be analyzed by Fisher's exact test.

           3-5) Hospitalization period between experimental group and control group will be
           analyzed by Student's t-test.

        4. Experimental group of scopolamine patch application will be expected to have less
           severity of nausea and fewer numbers of vomiting or antiemetic usages. Ultimately, this
           may relate to hospitalization period and it will be decreased.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in Degree of nausea: Visual Analogue Scale (VAS)
time frame: just immediate after arrival at a recovery room or the ward and 4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery
description: Subjects will describe their subject degree of nausea by VAS score, just immediate after arrival at a recovery room or the ward and 4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery. Respondents specify their degree of nausea by indicating a point along a continuous 10cm line between two end-points; left one is for "No nausea" and the right one for "Very severe nausea". Scoring is based on the length from left point and higher score means more severe degree of nausea.
arm group label: Placebo group (P group)
arm group type: Placebo Comparator
description: The group that not existed scopolamine ingredient.
dosage form: apply
dosage: 1.5 mg
frequency: 1 times (at 9 p.m. of the day before the operation day)
duration: Until the 24hr after operation.
Patients will be applied patch that not existed scopolamine ingredient.
arm group label: Scopolamine group (S group)
arm group type: Experimental
description: 'Scopolamine (1.5mg) 1 patch'
The group that existed scopolamine ingredient
dosage form: apply
dosage: 1.5 mg
frequency: 1 times (at 9 p.m. of the day before the operation day)
duration: Until the 24hr after operation.
Patients will be applied patch that existed scopolamine ingredient.
intervention type: Drug
intervention name: Scopolamine
description: Patch will be applied under the ear of the opposite side of operation, at 9 p.m. of the day before the operation day. Nausea will be assessed by Visual Analogue Scale (VAS) immediate after arrival at a recovery room and the ward. After that, nausea will be continuously assessed every 4 hour (4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery) and a number of vomiting will also be counted. Basic clinical characteristics and the number of antiemetic administration will be identified through medical records.
arm group label: Scopolamine group (S group)
intervention type: Drug
intervention name: Placebo
description: Patch will be applied under the ear of the opposite side of operation, at 9 p.m. of the day before the operation day. Nausea will be assessed by Visual Analogue Scale (VAS) immediate after arrival at a recovery room and the ward. After that, nausea will be continuously assessed every 4 hour (4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery) and a number of vomiting will also be counted. Basic clinical characteristics and the number of antiemetic administration will be identified through medical records.
arm group label: Placebo group (P group)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jung Ho Han, PhD
role: Principal Investigator
affiliation: Seoul National University Bundang Hospital
last name: Jung Ho Han, PhD
phone: +82-31-787-7172
email: nstaus29@snubh.org
last name: Eun-Jin Choi
phone: +82-31-787-7165
email: r0415@snubh.org
citation: Sato K, Sai S, Adachi T. Is microvascular decompression surgery a high risk for postoperative nausea and vomiting in patients undergoing craniotomy? J Anesth. 2013 Oct;27(5):725-30. doi: 10.1007/s00540-013-1621-9. Epub 2013 May 7.
PMID: 23649917
citation: Pergolizzi JV Jr, Philip BK, Leslie JB, Taylor R Jr, Raffa RB. Perspectives on transdermal scopolamine for the treatment of postoperative nausea and vomiting. J Clin Anesth. 2012 Jun;24(4):334-45. doi: 10.1016/j.jclinane.2011.07.019.
PMID: 22608591
citation: Einarsson JI, Audbergsson BO, Thorsteinsson A. Scopolamine for prevention of postoperative nausea in gynecologic laparoscopy, a randomized trial. J Minim Invasive Gynecol. 2008 Jan-Feb;15(1):26-31. doi: 10.1016/j.jmig.2007.08.616.
PMID: 18262140
citation: Apfel CC, Zhang K, George E, Shi S, Jalota L, Hornuss C, Fero KE, Heidrich F, Pergolizzi JV, Cakmakkaya OS, Kranke P. Transdermal scopolamine for the prevention of postoperative nausea and vomiting: a systematic review and meta-analysis. Clin Ther. 2010 Nov;32(12):1987-2002. doi: 10.1016/j.clinthera.2010.11.014. Erratum In: Clin Ther. 2010 Dec;32(14):2502.
PMID: 21118734
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jung Ho Han
investigator title: Associate Professor
mesh term: Vomiting
mesh term: Postoperative Nausea and Vomiting
mesh term: Scopolamine
mesh term: Butylscopolammonium Bromide
sharing ipd: No
submitted: March 10, 2020
returned: March 24, 2020