<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/NCT04461093</url>
  </required_header>
  <id_info>
    <org_study_id>PalanosetronUSM</org_study_id>
    <nct_id>NCT04461093</nct_id>
  </id_info>
  <brief_title>Comparison of the Efficacy of Acupressure P6 Point, Dexamethasone and Ondansetron Versus Palonosetron Monotherapy for Preventing Postoperative Nausea and Vomiting in Laparoscopic Surgery</brief_title>
  <official_title>Comparison of the Efficacy of Acupressure P6 Point, Dexamethasone and Ondansetron Versus Palonosetron Monotherapy for Preventing Postoperative Nausea and Vomiting in Laparoscopic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mohd Zulfakar Mazlan, MBBS</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universiti Sains Malaysia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Postoperative nausea and vomiting (PONV) is defined as nausea and/or vomiting occurring&#xD;
      within 24 hours after surgery, it commonly affects 20-30% patients but as high as 70-80%&#xD;
      patients who are deemed high risk for PONV may be affected. PONV may cause unpleasant&#xD;
      complications such as dehydration, electrolyte imbalance, suture dehiscence, aspiration of&#xD;
      gastric contents, delayed recovery and prolonged hospital stay. Standard guideline&#xD;
      recommended combination of anti-emetics to prevent PONV in high risk patients. The commonly&#xD;
      used agents are dexamethasone and ondansetron which are cheaper although they are proven to&#xD;
      be less effective as single agent when compared with newer agent such as palonosetron. As an&#xD;
      adjunct or alternative to pharmacological treatment, acupressure P6 point has gained&#xD;
      increasing attention for its possible value in preventing PONV. It is proven that acupressure&#xD;
      reduced the incidences of PONV when combined with pharmacological treatment. It is postulated&#xD;
      that acupressure active Aβ and Aδ fibres and stimulate the release of β-endorphine from&#xD;
      hypothalamus. In addition, it is believed that acupressure might act on dopaminergic,&#xD;
      serotonergic and norepinerphrinergic fibres which might has a role in PONV prevention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is designed to compare the efficacy of palonosetron monotherapy versus combination&#xD;
      of acupressure P6 point with dexamethasone and ondansetron in preventing PONV. It has been&#xD;
      proven that palonosetron is more superior as single agent when compared with acupressure,&#xD;
      dexamethasone and ondansetron separately. However, this might not be cost effective as&#xD;
      palonosetron is more expensive than the other agents. In addition, the combination therapy&#xD;
      has been reported better in preventing PONV when compared with monotherapy. The investigators&#xD;
      need to investigate whether the combination of acupressure with dexamethasone and ondansetron&#xD;
      exert an effect equal or even better than palonosetron monotherapy. The investigators&#xD;
      hypothesis is the combination of acupressure P6 point with dexamethasone and ondansetron&#xD;
      provide better prophylaxis againts PONV when compared with palonosetron. The requirement for&#xD;
      rescue anti-emetics for combination of acupressure P6 point with dexamethasone and&#xD;
      ondansetron group is lesser than palonosetron.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 6, 2020</start_date>
  <completion_date type="Anticipated">November 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2021</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>
    <intervention_model_description>Double blinded, Randomized Controlled Trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Potential patients are identified and consented for study during pre-operative assessment. Both patients and assessors are blinded in this trial.&#xD;
Participants and assessors are being blinded of the treatment or medications given intra-operatively. The acupressure wristband and anti-emetics will be given after general anaesthesia. The wristband will be removed prior to emergence, participants will not aware of the methods used to prevent nausea and vomiting. Postoperative participants will be assessed by independent nurses who are not involved in the study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of postoperative nausea and vomiting immediately, at</measure>
    <time_frame>Hours 6, postoperative.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The incidence of postoperative nausea and vomiting immediately, at</measure>
    <time_frame>Hours 12, postoperative</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The incidence of postoperative nausea and vomiting immediately, at</measure>
    <time_frame>Hours 24, postoperative</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The incidence of postoperative nausea and vomiting immediately, at</measure>
    <time_frame>Hours 48, postoperative</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients require rescue anti-emetics immediately,</measure>
    <time_frame>at Hours 6, postoperative.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients require rescue anti-emetics immediately,</measure>
    <time_frame>Hours 12, postoperative.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients require rescue anti-emetics immediately,</measure>
    <time_frame>Hours 24, postoperative.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients require rescue anti-emetics immediately,</measure>
    <time_frame>Hours 48, postoperative.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Palonosetron</condition>
  <arm_group>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group I (n=45)&#xD;
Acupressure wristband&#xD;
IV Dexamethasone 8mg&#xD;
IV Ondansetron 4mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group II (n=45)&#xD;
1. IV Palonosetron 0.075mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acupressure wristband and Palanosetron</intervention_name>
    <description>Group 1 Patients with odd numbers labelled form will be Group I patients. They will receive intravenous dexamethasone 8mg during induction. Acupressure P6 wristband is applied after induction and removed prior to emergence to maintain blinding. Intravenous ondansetron 4mg is given prior to skin closure.&#xD;
Group 11 Patients with even numbers labelled form will be Group II patients who will receive intravenous palonosetron 0.075mg during induction.</description>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_label>Group II</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ASA I or II female patients aged 18 - 65 years old in view female patients are at&#xD;
             higher risk of postoperative nausea and vomiting.&#xD;
&#xD;
          2. Patients undergoing laparoscopic surgery.&#xD;
&#xD;
          3. High risk for PONV (APFEL score 3-4).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with known allergic to dexamethasone, ondansetron and wristband.&#xD;
&#xD;
          2. Patients who take anti-emetic, emetogenic drugs and glucocorticoids within 24 hours&#xD;
             before surgery.&#xD;
&#xD;
          3. Patients with upper limb disability which affect the application of wristband.&#xD;
&#xD;
          4. Obese patients with BMI &gt; 35 in view acupressure P6 wristband might be too tight to&#xD;
             fit patient's wrist which might affect the correct placement of pressure point.&#xD;
&#xD;
          5. Pre-existing vertigo&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mohd Zulfakar Mazlan, MBBS</name>
      <address>
        <city>Kota Bharu</city>
        <state>Kelantan</state>
        <zip>16150</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Mohd Zulfakar Mazlan, MBBS</last_name>
      <phone>+6097673000</phone>
      <phone_ext>6104</phone_ext>
      <email>zulfakar@usm.my</email>
    </contact>
    <contact_backup>
      <phone>+60129091447</phone>
    </contact_backup>
    <investigator>
      <last_name>Woei Zhong Chiong, MBBS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mohd Zulfakar Mazlan</name>
      <address>
        <city>Kota Bharu</city>
        <state>Kelantan</state>
        <zip>16150</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohd Zulfakar Mazlan, MBBS</last_name>
      <phone>+60129091447</phone>
      <phone_ext>6104</phone_ext>
      <email>zulfakar@usm.my</email>
    </contact>
    <investigator>
      <last_name>Zhong Woei Chiong, MBBS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>April 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Universiti Sains Malaysia</investigator_affiliation>
    <investigator_full_name>Mohd Zulfakar Mazlan, MBBS</investigator_full_name>
    <investigator_title>Comparison of the efficacy of acupressure P6 point, dexamethasone and ondansetron versus palonosetron monotherapy for preventing postoperative nausea and vomiting in laparoscopic surgery</investigator_title>
  </responsible_party>
  <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>
  <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/NCT04461093
org study id: PalanosetronUSM
nct id: NCT04461093
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Postoperative nausea and vomiting (PONV) is defined as nausea and/or vomiting occurring
      within 24 hours after surgery, it commonly affects 20-30% patients but as high as 70-80%
      patients who are deemed high risk for PONV may be affected. PONV may cause unpleasant
      complications such as dehydration, electrolyte imbalance, suture dehiscence, aspiration of
      gastric contents, delayed recovery and prolonged hospital stay. Standard guideline
      recommended combination of anti-emetics to prevent PONV in high risk patients. The commonly
      used agents are dexamethasone and ondansetron which are cheaper although they are proven to
      be less effective as single agent when compared with newer agent such as palonosetron. As an
      adjunct or alternative to pharmacological treatment, acupressure P6 point has gained
      increasing attention for its possible value in preventing PONV. It is proven that acupressure
      reduced the incidences of PONV when combined with pharmacological treatment. It is postulated
      that acupressure active Aβ and Aδ fibres and stimulate the release of β-endorphine from
      hypothalamus. In addition, it is believed that acupressure might act on dopaminergic,
      serotonergic and norepinerphrinergic fibres which might has a role in PONV prevention.
This study is designed to compare the efficacy of palonosetron monotherapy versus combination
      of acupressure P6 point with dexamethasone and ondansetron in preventing PONV. It has been
      proven that palonosetron is more superior as single agent when compared with acupressure,
      dexamethasone and ondansetron separately. However, this might not be cost effective as
      palonosetron is more expensive than the other agents. In addition, the combination therapy
      has been reported better in preventing PONV when compared with monotherapy. The investigators
      need to investigate whether the combination of acupressure with dexamethasone and ondansetron
      exert an effect equal or even better than palonosetron monotherapy. The investigators
      hypothesis is the combination of acupressure P6 point with dexamethasone and ondansetron
      provide better prophylaxis againts PONV when compared with palonosetron. The requirement for
      rescue anti-emetics for combination of acupressure P6 point with dexamethasone and
      ondansetron group is lesser than palonosetron.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Double blinded, Randomized Controlled Trial
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Potential patients are identified and consented for study during pre-operative assessment. Both patients and assessors are blinded in this trial.
Participants and assessors are being blinded of the treatment or medications given intra-operatively. The acupressure wristband and anti-emetics will be given after general anaesthesia. The wristband will be removed prior to emergence, participants will not aware of the methods used to prevent nausea and vomiting. Postoperative participants will be assessed by independent nurses who are not involved in the study.
measure: The incidence of postoperative nausea and vomiting immediately, at
time frame: Hours 6, postoperative.
measure: The incidence of postoperative nausea and vomiting immediately, at
time frame: Hours 12, postoperative
measure: The incidence of postoperative nausea and vomiting immediately, at
time frame: Hours 24, postoperative
measure: The incidence of postoperative nausea and vomiting immediately, at
time frame: Hours 48, postoperative
measure: The proportion of patients require rescue anti-emetics immediately,
time frame: at Hours 6, postoperative.
measure: The proportion of patients require rescue anti-emetics immediately,
time frame: Hours 12, postoperative.
measure: The proportion of patients require rescue anti-emetics immediately,
time frame: Hours 24, postoperative.
measure: The proportion of patients require rescue anti-emetics immediately,
time frame: Hours 48, postoperative.
arm group label: Group I
arm group type: Experimental
description: Group I (n=45)
Acupressure wristband
IV Dexamethasone 8mg
IV Ondansetron 4mg
arm group label: Group II
arm group type: Active Comparator
description: Group II (n=45)
1. IV Palonosetron 0.075mg
intervention type: Other
intervention name: Acupressure wristband and Palanosetron
description: Group 1 Patients with odd numbers labelled form will be Group I patients. They will receive intravenous dexamethasone 8mg during induction. Acupressure P6 wristband is applied after induction and removed prior to emergence to maintain blinding. Intravenous ondansetron 4mg is given prior to skin closure.
Group 11 Patients with even numbers labelled form will be Group II patients who will receive intravenous palonosetron 0.075mg during induction.
arm group label: Group I
arm group label: Group II
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Not yet recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Malaysia
responsible party type: Sponsor-Investigator
investigator affiliation: Universiti Sains Malaysia
investigator full name: Mohd Zulfakar Mazlan, MBBS
investigator title: Comparison of the efficacy of acupressure P6 point, dexamethasone and ondansetron versus palonosetron monotherapy for preventing postoperative nausea and vomiting in laparoscopic surgery
mesh term: Vomiting
mesh term: Postoperative Nausea and Vomiting
sharing ipd: No