<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/NCT02984839</url>
  </required_header>
  <id_info>
    <org_study_id>16-0047</org_study_id>
    <nct_id>NCT02984839</nct_id>
  </id_info>
  <brief_title>Incidence of Residual Neuromuscular Blockade in Intra-abdominal Surgery: A Prospective, Observational Study</brief_title>
  <official_title>Incidence of Residual Neuromuscular Blockade in Intra-abdominal Surgery: A Prospective, Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OhioHealth</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>OhioHealth</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this prospective, observational study is to determine the incidence of&#xD;
      post-operative residual neuromuscular blockade (PRNB) in patients undergoing intra-abdominal&#xD;
      procedures compared to patients undergoing other noncardiac/non intra-thoracic procedures&#xD;
      that also require non-depolarizing neuromuscular blocking agents (NMBA) administration. As&#xD;
      intra-abdominal surgeries are independently associated with post-operative pulmonary&#xD;
      complications (PPCs), it is important to highlight other factors, such as PRNB, that could&#xD;
      contribute to these complications.Although it has been shown that the risk of adverse&#xD;
      respiratory events can be reduced by intra-operative quantitative neuromuscular monitoring,&#xD;
      such monitoring is not in widespread use.This study will incorporate quantitative monitoring&#xD;
      in the post-anesthesia care unit (PACU) setting by using the Stimpod NMS450® in an effort to&#xD;
      show a disparity in the incidence of residual paralysis between these two patient populations&#xD;
      and to emphasize the need to implement more accurate neuromuscular monitoring, especially for&#xD;
      those that are already at increased risk for respiratory complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Residual paralysis from non-depolarizing neuromuscular blocking agents (NMBAs) is a common&#xD;
      problem that contributes to adverse outcomes in the post-anesthesia care unit&#xD;
      (PACU).Unidentified residual neuromuscular blockade (defined as a train-of-four (TOF) ratio&#xD;
      &lt;0.9) has been reported in up to 30-42% of patients in the recovery room.Though current&#xD;
      literature supports the use of quantitative monitoring of neuromuscular blockade,&#xD;
      conventional qualitative TOF count monitoring and clinical signs (head lift, grip strength)&#xD;
      continue to be used.There is strong evidence that shows reduction of clinically significant&#xD;
      post-operative residual neuromuscular blockade (PRNB) after implementation of quantitative&#xD;
      monitoring. Post-operative pulmonary complications (PPCs) are notable adverse outcomes of&#xD;
      residual neuromuscular blockade. The implementation of quantitative monitoring may be&#xD;
      particularly beneficial to patients who are already predisposed to PPCs secondary to the site&#xD;
      of surgery.&#xD;
&#xD;
      The purpose of this study is to evaluate the incidence of PRNB with use of quantitative&#xD;
      neuromuscular monitoring in patients undergoing intra-abdominal procedures compared to&#xD;
      patients undergoing other surgical procedures that also require NMBA administration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">May 16, 2017</completion_date>
  <primary_completion_date type="Actual">March 21, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Train-of-four (TOF) ratio</measure>
    <time_frame>15 minutes post arrival in the post anesthesia care unit (PACU)</time_frame>
    <description>Average TOF ratio will be calculated from two consecutive readings using the Stimpod NMS450 within 15 minutes of arrival in the PACU</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Need for supplemental O2 therapy</measure>
    <time_frame>30 minutes post arrival in the PACU</time_frame>
    <description>Necessity for supplemental O2 therapy after 30 minutes in PACU will be recorded via chart review to determine post operative pulmonary complication</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">120</enrollment>
  <condition>Neuromuscular Blockade</condition>
  <condition>Pulmonary Complication</condition>
  <arm_group>
    <arm_group_label>Intra-abdominal surgery group</arm_group_label>
    <description>The study population will include patients presenting for elective or non-elective intra-abdominal surgery requiring general anesthesia with neuromuscular blockade at OhioHealth Doctors Hospital.&#xD;
Quantitative TOF will be recorded by Stimpod NMS450 in PACU.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-intra-abdominal surgery group</arm_group_label>
    <description>The study population will include patients presenting for elective or non-elective non intra-abdominal surgery requiring general anesthesia with neuromuscular blockade at OhioHealth Doctors Hospital.&#xD;
Quantitative TOF will be recorded by Stimpod NMS450 in PACU.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stimpod NMS450® Nerve Stimulator, by Xavant™ Technology</intervention_name>
    <description>Quantitative train-of-four (TOF) ratio will be recorded in the post anesthesia care unit (PACU) via Stimpod NMS450</description>
    <arm_group_label>Intra-abdominal surgery group</arm_group_label>
    <arm_group_label>Non-intra-abdominal surgery group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will include all patients age 18 or older with American Society of&#xD;
        Anesthesiologists (ASA) physical status I-IV presenting for elective or non-elective&#xD;
        surgery requiring general anesthesia with neuromuscular blockade.While previous studies&#xD;
        have found that up to 30-42% of patients experience PRNB in the PACU, no previous studies&#xD;
        have estimated the incidence of PRNB by surgical procedure (i.e., intra-abdominal versus&#xD;
        other surgical procedures).Therefore, this study will be more descriptive in nature.A&#xD;
        difference of at least 10% in the incidence of PRNB between the two groups will be&#xD;
        considered clinically significant.A maximum number of 120 (approximately 60 patients who&#xD;
        undergo intra-abdominal surgery and 60 patients who undergo non intra-abdominal surgical&#xD;
        procedures) will be enrolled during the course of the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  ASA physical status classification I-IV&#xD;
&#xD;
          -  Procedures requiring intubation and nondepolarizing NMBA administration&#xD;
&#xD;
               -  Laparoscopic surgery&#xD;
&#xD;
               -  Intra-abdominal surgery&#xD;
&#xD;
               -  Procedures using the Da Vinci surgical system&#xD;
&#xD;
               -  Tonsillectomy&#xD;
&#xD;
               -  Septoplasty&#xD;
&#xD;
               -  Shoulder surgery&#xD;
&#xD;
               -  Total hip arthroplasty&#xD;
&#xD;
               -  Carotid endarterectomy&#xD;
&#xD;
               -  Cervical spine surgery&#xD;
&#xD;
               -  Parotidectomy&#xD;
&#xD;
               -  Thyroidectomy&#xD;
&#xD;
               -  Aorto-bifemoral bypass&#xD;
&#xD;
               -  Micro laryngoscopy&#xD;
&#xD;
               -  Nasal or sinus surgery&#xD;
&#xD;
               -  Dental extraction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speaking population&#xD;
&#xD;
          -  ASA V and VI&#xD;
&#xD;
          -  Unable to give informed consent&#xD;
&#xD;
          -  Cardiac or intra-thoracic procedures performed&#xD;
&#xD;
          -  Severe renal insufficiency (Serum Creatinine &gt;2.0 mg/dL)&#xD;
&#xD;
          -  Severe hepatic dysfunction&#xD;
&#xD;
          -  Underlying neuromuscular disease&#xD;
&#xD;
          -  Currently enrolled in another therapeutic study&#xD;
&#xD;
          -  Pregnant patients at any stage of pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kayla Petersen, D.O.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Resident Physician</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OhioHealth Doctors Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>December 3, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>July 24, 2018</last_update_submitted>
  <last_update_submitted_qc>July 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>OhioHealth</investigator_affiliation>
    <investigator_full_name>Kayla Petersen</investigator_full_name>
    <investigator_title>Resident Physician</investigator_title>
  </responsible_party>
  <keyword>intra-abdominal surgery</keyword>
  <keyword>neuromuscular blocking agent</keyword>
  <keyword>post-anesthesia care unit</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delayed Emergence from Anesthesia</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/NCT02984839
org study id: 16-0047
nct id: NCT02984839
lead sponsor: 
has dmc: No
The aim of this prospective, observational study is to determine the incidence of
      post-operative residual neuromuscular blockade (PRNB) in patients undergoing intra-abdominal
      procedures compared to patients undergoing other noncardiac/non intra-thoracic procedures
      that also require non-depolarizing neuromuscular blocking agents (NMBA) administration. As
      intra-abdominal surgeries are independently associated with post-operative pulmonary
      complications (PPCs), it is important to highlight other factors, such as PRNB, that could
      contribute to these complications.Although it has been shown that the risk of adverse
      respiratory events can be reduced by intra-operative quantitative neuromuscular monitoring,
      such monitoring is not in widespread use.This study will incorporate quantitative monitoring
      in the post-anesthesia care unit (PACU) setting by using the Stimpod NMS450® in an effort to
      show a disparity in the incidence of residual paralysis between these two patient populations
      and to emphasize the need to implement more accurate neuromuscular monitoring, especially for
      those that are already at increased risk for respiratory complications.
Residual paralysis from non-depolarizing neuromuscular blocking agents (NMBAs) is a common
      problem that contributes to adverse outcomes in the post-anesthesia care unit
      (PACU).Unidentified residual neuromuscular blockade (defined as a train-of-four (TOF) ratio
      <0.9) has been reported in up to 30-42% of patients in the recovery room.Though current
      literature supports the use of quantitative monitoring of neuromuscular blockade,
      conventional qualitative TOF count monitoring and clinical signs (head lift, grip strength)
      continue to be used.There is strong evidence that shows reduction of clinically significant
      post-operative residual neuromuscular blockade (PRNB) after implementation of quantitative
      monitoring. Post-operative pulmonary complications (PPCs) are notable adverse outcomes of
      residual neuromuscular blockade. The implementation of quantitative monitoring may be
      particularly beneficial to patients who are already predisposed to PPCs secondary to the site
      of surgery.

      The purpose of this study is to evaluate the incidence of PRNB with use of quantitative
      neuromuscular monitoring in patients undergoing intra-abdominal procedures compared to
      patients undergoing other surgical procedures that also require NMBA administration.
observational model: Other
time perspective: Cross-Sectional
measure: Train-of-four (TOF) ratio
time frame: 15 minutes post arrival in the post anesthesia care unit (PACU)
description: Average TOF ratio will be calculated from two consecutive readings using the Stimpod NMS450 within 15 minutes of arrival in the PACU
measure: Need for supplemental O2 therapy
time frame: 30 minutes post arrival in the PACU
description: Necessity for supplemental O2 therapy after 30 minutes in PACU will be recorded via chart review to determine post operative pulmonary complication
arm group label: Intra-abdominal surgery group
description: The study population will include patients presenting for elective or non-elective intra-abdominal surgery requiring general anesthesia with neuromuscular blockade at OhioHealth Doctors Hospital.
Quantitative TOF will be recorded by Stimpod NMS450 in PACU.
arm group label: Non-intra-abdominal surgery group
description: The study population will include patients presenting for elective or non-elective non intra-abdominal surgery requiring general anesthesia with neuromuscular blockade at OhioHealth Doctors Hospital.
Quantitative TOF will be recorded by Stimpod NMS450 in PACU.
intervention type: Device
intervention name: Stimpod NMS450® Nerve Stimulator, by Xavant™ Technology
description: Quantitative train-of-four (TOF) ratio will be recorded in the post anesthesia care unit (PACU) via Stimpod NMS450
arm group label: Intra-abdominal surgery group
arm group label: Non-intra-abdominal surgery group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kayla Petersen, D.O.
role: Principal Investigator
affiliation: Resident Physician
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: OhioHealth
investigator full name: Kayla Petersen
investigator title: Resident Physician
mesh term: Delayed Emergence from Anesthesia
sharing ipd: No