<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/NCT03287388</url>
  </required_header>
  <id_info>
    <org_study_id>63227.091.17</org_study_id>
    <nct_id>NCT03287388</nct_id>
  </id_info>
  <brief_title>MRI Measurement of the Effects of Deep Neuromuscular Blockade on the Abdominal Working Space During Laparoscopy</brief_title>
  <acronym>RELAX-2</acronym>
  <official_title>MRI Measurement of the Effects of Moderate Versus Deep Neuromuscular Blockade on the Abdominal Working Space During Laparoscopic Surgery in a Prospective Cohort Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Radboud University Medical Center</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      During laparoscopy, a surgical working space is obtained by creation of a pneumoperitoneum.&#xD;
      Optimal surgical conditions are essential to ensure the patient's safety. A meta-analysis on&#xD;
      studies comparing the influence of deep and moderate neuromuscular blockade (NMB) on the&#xD;
      quality of the surgical space conditions during laparoscopy (1), showed that compared to&#xD;
      moderate NMB, deep neuromuscular blockade improves the surgical space conditions, assessed by&#xD;
      the Leiden-Surgical Rating scale, as reported by Martini and colleagues (2).&#xD;
&#xD;
      In this prospective cohort study, we will assess the influence of deep neuromuscular blockade&#xD;
      on the surgical space, measured by magnetic resonance imaging (MRI) in patients scheduled for&#xD;
      laparoscopic donor nephrectomy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: To establish the influence of deep neuromuscular blockade (NMB) on the abdominal&#xD;
      working space during laparoscopy.&#xD;
&#xD;
      Study design: A single center prospective cohort study&#xD;
&#xD;
      Study population: 10 adult patients (18 years or older), equally distributed by gender,&#xD;
      scheduled for laparoscopic donor nephrectomy&#xD;
&#xD;
      Study procedures:&#xD;
&#xD;
      Induction of general anesthesia followed by intubation and creation of a pneumoperitoneum (12&#xD;
      mmHg).&#xD;
&#xD;
      Each patient will have a MRI scan during 3 stages:&#xD;
&#xD;
      Phase 1: No neuromuscular blockade (TOF ratio 1) Phase 2: moderate neuromuscular blockade(TOF&#xD;
      1-3). Phase 3: deep neuromuscular blockade (PTC 0-1)&#xD;
&#xD;
      Primary outcome:&#xD;
&#xD;
      The abdominal space measured by MRI: Skin - sacral promontory distance&#xD;
&#xD;
      Secondary outcome:&#xD;
&#xD;
      3D volume measurement of the abdominal cavity by MRI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">May 2019</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">November 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Each patient wil serve as its own control:&#xD;
Each patient will start without neuromuscular blockade (phase 1), followed by moderate neuromuscular blockade (phase 2) and deep neuromuscular blockade (phase 3).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Abdominal working space</measure>
    <time_frame>3 times (phase 1 (no neuromuscular blockade, phase 2 moderate neuromuscular blockade, phase 3 deep neuromuscular blockade. From start of surgery until third scan, total duration of 30 minutes</time_frame>
    <description>Skin-sacral promontory distance, measured by MRI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Abdominal volume</measure>
    <time_frame>3 times (phase 1 no neuromuscular blockade, phase 2 moderate neuromuscular blockade, phase 3 deep neuromuscular blockade. From start of surgery until third scan, total duration of 30 minutes</time_frame>
    <description>3D volume abdominal cavity, measured by MRI</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">8</enrollment>
  <condition>Neuromuscular Block</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>No Rocuronium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phase 1: no neuromuscular blockade</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rocuronium (moderate NMB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phase 2: moderate neuromuscular blockade (TOF 1-3)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rocuronium (deep NMB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phase 3: deep neuromuscular blockade (PTC 0-1)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>No Rocuronium</intervention_name>
    <description>Phase 1: The patient will undergo a routine MRI-abdomen without neuromuscular blockade: TOF ratio =1.</description>
    <arm_group_label>No Rocuronium</arm_group_label>
    <other_name>No neuromuscular blockade</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rocuronium (moderate NMB)</intervention_name>
    <description>Phase 2: Rocuronium will be titrated to a moderate NMB (TOF 1-3), monitored by TOF-watch. When an adequate moderate NMB is achieved, the patient will undergo a second MRI-abdomen.</description>
    <arm_group_label>Rocuronium (moderate NMB)</arm_group_label>
    <other_name>Moderate neuromuscular blockade (Rocuronium)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rocuronium (deep NMB)</intervention_name>
    <description>Phase 3: The patient receives a bolus of 1.2 mg/kg rocuronium (adjusted to ideal body weight), to assure a deep or intense NMB (PTC 0-1). Then the patient will undergo the final, third MRI scan of the abdomen.</description>
    <arm_group_label>Rocuronium (deep NMB)</arm_group_label>
    <other_name>Deep neuromuscular blockade (Rocuronium)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  scheduled for laparoscopic donor nephrectomy&#xD;
&#xD;
          -  obtained informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
&#xD;
          -  known or suspect allergy to mivacurium, rocuronium or sugammadex&#xD;
&#xD;
          -  neuromuscular disease&#xD;
&#xD;
          -  indication for rapid sequence induction&#xD;
&#xD;
          -  Being unable to undergo MRI due to any reason (e.g. non MRI-compatible implants,&#xD;
             epilepsy)&#xD;
&#xD;
          -  BMI&gt;30 kg/m2&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) classification &gt;2&#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>Michiel C Warlé, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Radboud University Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Moira HD Bruintjes, Msc.</last_name>
    <phone>(+)31-24-3617612</phone>
    <email>Moira.Bruintjes@radboudumc.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Piet Krijtenburg, Drs.</last_name>
    <phone>(+)31-24-3619032</phone>
    <email>Piet.Krijtenburg@radboudumc.nl</email>
  </overall_contact_backup>
  <reference>
    <citation>Bruintjes MH, van Helden EV, Braat AE, Dahan A, Scheffer GJ, van Laarhoven CJ, Warle MC. Deep neuromuscular block to optimize surgical space conditions during laparoscopic surgery: a systematic review and meta-analysis. Br J Anaesth. 2017 Jun 1;118(6):834-842. doi: 10.1093/bja/aex116.</citation>
    <PMID>28575335</PMID>
  </reference>
  <reference>
    <citation>Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15.</citation>
    <PMID>24240315</PMID>
  </reference>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>April 1, 2019</last_update_submitted>
  <last_update_submitted_qc>April 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Laparoscopic surgery</keyword>
  <keyword>Abdominal working space</keyword>
  <keyword>Moderate neuromuscular blockade</keyword>
  <keyword>Deep neuromuscular blockade</keyword>
  <keyword>MRI measurement</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rocuronium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>February 6, 2023</submitted>
    <submission_canceled>July 17, 2023</submission_canceled>
    <submitted>July 24, 2023</submitted>
  </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/NCT03287388
org study id: 63227.091.17
nct id: NCT03287388
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
During laparoscopy, a surgical working space is obtained by creation of a pneumoperitoneum.
      Optimal surgical conditions are essential to ensure the patient's safety. A meta-analysis on
      studies comparing the influence of deep and moderate neuromuscular blockade (NMB) on the
      quality of the surgical space conditions during laparoscopy (1), showed that compared to
      moderate NMB, deep neuromuscular blockade improves the surgical space conditions, assessed by
      the Leiden-Surgical Rating scale, as reported by Martini and colleagues (2).

      In this prospective cohort study, we will assess the influence of deep neuromuscular blockade
      on the surgical space, measured by magnetic resonance imaging (MRI) in patients scheduled for
      laparoscopic donor nephrectomy
Objective: To establish the influence of deep neuromuscular blockade (NMB) on the abdominal
      working space during laparoscopy.

      Study design: A single center prospective cohort study

      Study population: 10 adult patients (18 years or older), equally distributed by gender,
      scheduled for laparoscopic donor nephrectomy

      Study procedures:

      Induction of general anesthesia followed by intubation and creation of a pneumoperitoneum (12
      mmHg).

      Each patient will have a MRI scan during 3 stages:

      Phase 1: No neuromuscular blockade (TOF ratio 1) Phase 2: moderate neuromuscular blockade(TOF
      1-3). Phase 3: deep neuromuscular blockade (PTC 0-1)

      Primary outcome:

      The abdominal space measured by MRI: Skin - sacral promontory distance

      Secondary outcome:

      3D volume measurement of the abdominal cavity by MRI.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: Each patient wil serve as its own control:
Each patient will start without neuromuscular blockade (phase 1), followed by moderate neuromuscular blockade (phase 2) and deep neuromuscular blockade (phase 3).
primary purpose: Treatment
masking: None (Open Label)
measure: Abdominal working space
time frame: 3 times (phase 1 (no neuromuscular blockade, phase 2 moderate neuromuscular blockade, phase 3 deep neuromuscular blockade. From start of surgery until third scan, total duration of 30 minutes
description: Skin-sacral promontory distance, measured by MRI
measure: Abdominal volume
time frame: 3 times (phase 1 no neuromuscular blockade, phase 2 moderate neuromuscular blockade, phase 3 deep neuromuscular blockade. From start of surgery until third scan, total duration of 30 minutes
description: 3D volume abdominal cavity, measured by MRI
arm group label: No Rocuronium
arm group type: Experimental
description: Phase 1: no neuromuscular blockade
arm group label: Rocuronium (moderate NMB)
arm group type: Experimental
description: Phase 2: moderate neuromuscular blockade (TOF 1-3)
arm group label: Rocuronium (deep NMB)
arm group type: Experimental
description: Phase 3: deep neuromuscular blockade (PTC 0-1)
intervention type: Procedure
intervention name: No Rocuronium
description: Phase 1: The patient will undergo a routine MRI-abdomen without neuromuscular blockade: TOF ratio =1.
arm group label: No Rocuronium
other name: No neuromuscular blockade
intervention type: Drug
intervention name: Rocuronium (moderate NMB)
description: Phase 2: Rocuronium will be titrated to a moderate NMB (TOF 1-3), monitored by TOF-watch. When an adequate moderate NMB is achieved, the patient will undergo a second MRI-abdomen.
arm group label: Rocuronium (moderate NMB)
other name: Moderate neuromuscular blockade (Rocuronium)
intervention type: Drug
intervention name: Rocuronium (deep NMB)
description: Phase 3: The patient receives a bolus of 1.2 mg/kg rocuronium (adjusted to ideal body weight), to assure a deep or intense NMB (PTC 0-1). Then the patient will undergo the final, third MRI scan of the abdomen.
arm group label: Rocuronium (deep NMB)
other name: Deep neuromuscular blockade (Rocuronium)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michiel C Warlé, Dr.
role: Principal Investigator
affiliation: Radboud University Medical Center
last name: Moira HD Bruintjes, Msc.
phone: (+)31-24-3617612
email: Moira.Bruintjes@radboudumc.nl
last name: Piet Krijtenburg, Drs.
phone: (+)31-24-3619032
email: Piet.Krijtenburg@radboudumc.nl
citation: Bruintjes MH, van Helden EV, Braat AE, Dahan A, Scheffer GJ, van Laarhoven CJ, Warle MC. Deep neuromuscular block to optimize surgical space conditions during laparoscopic surgery: a systematic review and meta-analysis. Br J Anaesth. 2017 Jun 1;118(6):834-842. doi: 10.1093/bja/aex116.
PMID: 28575335
citation: Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15.
PMID: 24240315
responsible party type: Sponsor
mesh term: Rocuronium
sharing ipd: Undecided
submitted: February 6, 2023
submission canceled: July 17, 2023
submitted: July 24, 2023