<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/NCT01718860</url>
  </required_header>
  <id_info>
    <org_study_id>2016P002695</org_study_id>
    <secondary_id>IISP#39443</secondary_id>
    <nct_id>NCT01718860</nct_id>
  </id_info>
  <brief_title>Effects of Postoperative Residual Paralysis on Hospital Costs</brief_title>
  <official_title>Effects of Postoperative Residual Paralysis on Costs of Hospital Care, Length of Hospitalization and Intensive Care Unit Admission Rate</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a secondary analysis of a previously performed prospective, observer-blinded,&#xD;
      observational study at Massachusetts General Hospital. The primary aim of this study is to&#xD;
      evaluate the effects of residual paralysis at admission to the post-anesthesia care unit&#xD;
      (PACU) on total costs of hospital care.&#xD;
&#xD;
      Secondary analyses will be conducted to evaluate the effects of postoperative residual&#xD;
      paralysis on potential cost-influencing factors, i.e. incidence of minor and major&#xD;
      postoperative respiratory complications, hospital length of stay (LOS), unplanned intensive&#xD;
      care unit (ICU) admission rate, as well as length of stay in the PACU.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>April 2011</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Actual">February 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hospital costs</measure>
    <time_frame>Patients will be followed from date of admission to date of hospital discharge, an expected 2 days to 4 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital Length of Stay</measure>
    <time_frame>within 100 days after surgery</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence of postoperative respiratory complications</measure>
    <time_frame>Within one month after surgery</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of unplanned postoperative intensive care unit admission</measure>
    <time_frame>Within one week after surgery</time_frame>
    <description>Incidence of unplanned postoperative intensive care unit admission due to respiratory failure, pulmonary edema and arrhythmia.</description>
  </other_outcome>
  <other_outcome>
    <measure>Length of stay in the post-anesthesia care unit (PACU)</measure>
    <time_frame>Patients will be followed until PACU discharge, an expected 2 days to 2 weeks</time_frame>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Residual Paralysis, Post-Anesthesia</condition>
  <arm_group>
    <arm_group_label>Postoperative Residual Paralysis</arm_group_label>
    <description>Patients with train-of-four ratio less than 0.9 measured in the postanesthesia care unit</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Postoperative Residual Paralysis</arm_group_label>
    <description>Patients with train-of-four ratio greater than 0.9 measured in the postanesthesia care unit</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Quantitative measurement of neuromuscular transmission</intervention_name>
    <description>Quantitative measurement of neuromuscular transmission with train-of-four watches.</description>
    <arm_group_label>No Postoperative Residual Paralysis</arm_group_label>
    <arm_group_label>Postoperative Residual Paralysis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients who arrived at the post-anesthesia care unit after receiving neuromuscular&#xD;
        blocking agents as part of their surgical anaesthesia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Each subject has been given non-depolarizing neuromuscular blocking agents as part of&#xD;
             general anesthesia.&#xD;
&#xD;
          -  Each subject must be at least 18 years of age&#xD;
&#xD;
          -  Train-of-four monitoring in the post-anesthesia care unit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject is scheduled to be transferred to an intensive care unit after surgery.&#xD;
&#xD;
          -  Children and pregnant women&#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>Matthias Eikermann, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Partners</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Butterly A, Bittner EA, George E, Sandberg WS, Eikermann M, Schmidt U. Postoperative residual curarization from intermediate-acting neuromuscular blocking agents delays recovery room discharge. Br J Anaesth. 2010 Sep;105(3):304-9. doi: 10.1093/bja/aeq157. Epub 2010 Jun 24.</citation>
    <PMID>20576632</PMID>
  </reference>
  <reference>
    <citation>Herbstreit F, Zigrahn D, Ochterbeck C, Peters J, Eikermann M. Neostigmine/glycopyrrolate administered after recovery from neuromuscular block increases upper airway collapsibility by decreasing genioglossus muscle activity in response to negative pharyngeal pressure. Anesthesiology. 2010 Dec;113(6):1280-8. doi: 10.1097/ALN.0b013e3181f70f3d.</citation>
    <PMID>20980910</PMID>
  </reference>
  <reference>
    <citation>Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Residual neuromuscular blockade and critical respiratory events in the postanesthesia care unit. Anesth Analg. 2008 Jul;107(1):130-7. doi: 10.1213/ane.0b013e31816d1268.</citation>
    <PMID>18635478</PMID>
  </reference>
  <reference>
    <citation>Berg H, Roed J, Viby-Mogensen J, Mortensen CR, Engbaek J, Skovgaard LT, Krintel JJ. Residual neuromuscular block is a risk factor for postoperative pulmonary complications. A prospective, randomised, and blinded study of postoperative pulmonary complications after atracurium, vecuronium and pancuronium. Acta Anaesthesiol Scand. 1997 Oct;41(9):1095-1103. doi: 10.1111/j.1399-6576.1997.tb04851.x.</citation>
    <PMID>9366929</PMID>
  </reference>
  <reference>
    <citation>Grosse-Sundrup M, Henneman JP, Sandberg WS, Bateman BT, Uribe JV, Nguyen NT, Ehrenfeld JM, Martinez EA, Kurth T, Eikermann M. Intermediate acting non-depolarizing neuromuscular blocking agents and risk of postoperative respiratory complications: prospective propensity score matched cohort study. BMJ. 2012 Oct 15;345:e6329. doi: 10.1136/bmj.e6329.</citation>
    <PMID>23077290</PMID>
  </reference>
  <reference>
    <citation>Sasaki N, Meyer MJ, Malviya SA, Stanislaus AB, MacDonald T, Doran ME, Igumenshcheva A, Hoang AH, Eikermann M. Effects of neostigmine reversal of nondepolarizing neuromuscular blocking agents on postoperative respiratory outcomes: a prospective study. Anesthesiology. 2014 Nov;121(5):959-68. doi: 10.1097/ALN.0000000000000440.</citation>
    <PMID>25225821</PMID>
  </reference>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>May 1, 2017</last_update_submitted>
  <last_update_submitted_qc>May 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Matthias Eikermann</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>Cost Analysis</keyword>
  <keyword>Postoperative Complications</keyword>
  <keyword>Length of Stay</keyword>
  <keyword>Intensive Care Units</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paralysis</mesh_term>
    <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/NCT01718860
org study id: 2016P002695
secondary id: IISP#39443
nct id: NCT01718860
lead sponsor: 
collaborator: 
has dmc: No
This is a secondary analysis of a previously performed prospective, observer-blinded,
      observational study at Massachusetts General Hospital. The primary aim of this study is to
      evaluate the effects of residual paralysis at admission to the post-anesthesia care unit
      (PACU) on total costs of hospital care.

      Secondary analyses will be conducted to evaluate the effects of postoperative residual
      paralysis on potential cost-influencing factors, i.e. incidence of minor and major
      postoperative respiratory complications, hospital length of stay (LOS), unplanned intensive
      care unit (ICU) admission rate, as well as length of stay in the PACU.
observational model: Cohort
time perspective: Prospective
measure: Hospital costs
time frame: Patients will be followed from date of admission to date of hospital discharge, an expected 2 days to 4 weeks
measure: Hospital Length of Stay
time frame: within 100 days after surgery
measure: Incidence of postoperative respiratory complications
time frame: Within one month after surgery
measure: Incidence of unplanned postoperative intensive care unit admission
time frame: Within one week after surgery
description: Incidence of unplanned postoperative intensive care unit admission due to respiratory failure, pulmonary edema and arrhythmia.
measure: Length of stay in the post-anesthesia care unit (PACU)
time frame: Patients will be followed until PACU discharge, an expected 2 days to 2 weeks
arm group label: Postoperative Residual Paralysis
description: Patients with train-of-four ratio less than 0.9 measured in the postanesthesia care unit
arm group label: No Postoperative Residual Paralysis
description: Patients with train-of-four ratio greater than 0.9 measured in the postanesthesia care unit
intervention type: Procedure
intervention name: Quantitative measurement of neuromuscular transmission
description: Quantitative measurement of neuromuscular transmission with train-of-four watches.
arm group label: No Postoperative Residual Paralysis
arm group label: Postoperative Residual Paralysis
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthias Eikermann, MD, PhD
role: Principal Investigator
affiliation: Partners
facility: 
country: United States
citation: Butterly A, Bittner EA, George E, Sandberg WS, Eikermann M, Schmidt U. Postoperative residual curarization from intermediate-acting neuromuscular blocking agents delays recovery room discharge. Br J Anaesth. 2010 Sep;105(3):304-9. doi: 10.1093/bja/aeq157. Epub 2010 Jun 24.
PMID: 20576632
citation: Herbstreit F, Zigrahn D, Ochterbeck C, Peters J, Eikermann M. Neostigmine/glycopyrrolate administered after recovery from neuromuscular block increases upper airway collapsibility by decreasing genioglossus muscle activity in response to negative pharyngeal pressure. Anesthesiology. 2010 Dec;113(6):1280-8. doi: 10.1097/ALN.0b013e3181f70f3d.
PMID: 20980910
citation: Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Residual neuromuscular blockade and critical respiratory events in the postanesthesia care unit. Anesth Analg. 2008 Jul;107(1):130-7. doi: 10.1213/ane.0b013e31816d1268.
PMID: 18635478
citation: Berg H, Roed J, Viby-Mogensen J, Mortensen CR, Engbaek J, Skovgaard LT, Krintel JJ. Residual neuromuscular block is a risk factor for postoperative pulmonary complications. A prospective, randomised, and blinded study of postoperative pulmonary complications after atracurium, vecuronium and pancuronium. Acta Anaesthesiol Scand. 1997 Oct;41(9):1095-1103. doi: 10.1111/j.1399-6576.1997.tb04851.x.
PMID: 9366929
citation: Grosse-Sundrup M, Henneman JP, Sandberg WS, Bateman BT, Uribe JV, Nguyen NT, Ehrenfeld JM, Martinez EA, Kurth T, Eikermann M. Intermediate acting non-depolarizing neuromuscular blocking agents and risk of postoperative respiratory complications: prospective propensity score matched cohort study. BMJ. 2012 Oct 15;345:e6329. doi: 10.1136/bmj.e6329.
PMID: 23077290
citation: Sasaki N, Meyer MJ, Malviya SA, Stanislaus AB, MacDonald T, Doran ME, Igumenshcheva A, Hoang AH, Eikermann M. Effects of neostigmine reversal of nondepolarizing neuromuscular blocking agents on postoperative respiratory outcomes: a prospective study. Anesthesiology. 2014 Nov;121(5):959-68. doi: 10.1097/ALN.0000000000000440.
PMID: 25225821
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Matthias Eikermann
investigator title: Dr.
mesh term: Paralysis
mesh term: Delayed Emergence from Anesthesia
sharing ipd: No