<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/NCT04466943</url>
  </required_header>
  <id_info>
    <org_study_id>E-19-3960</org_study_id>
    <nct_id>NCT04466943</nct_id>
  </id_info>
  <brief_title>The Impact of Moderate Versus Deep Neuromuscular Blockade on Enhanced Recovery After Bariatric Anesthesia</brief_title>
  <official_title>The Impact of Moderate Versus Deep Neuromuscular Blockade on Enhanced Recovery After Bariatric Anesthesia: A Randomized Double Blinded Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Saud University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Saud University</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>
      Most published articles suggest that deep neuromuscular blockade is required for bariatric&#xD;
      surgery. However, the evidence for such practice is still inconclusive. From the clinical&#xD;
      experience at a major bariatric center of volume exceeding six hundred procedures annually,&#xD;
      the investigators believe that moderate neuromuscular blockade will provide an adequate&#xD;
      surgical condition and significantly facilitate enhanced recovery after bariatric procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Muscle relaxation is paramount for successful laparoscopic surgery. However the optimal&#xD;
      degree of neuromuscular blockade (NMB) is not identified yet. Previous studies showed&#xD;
      conflicting results on the outcomes of laparoscopic surgical conditions when moderate NMB was&#xD;
      compared to deep blockade .The evidence for the use of either modalities is rather limited .&#xD;
      In the recent literature, there is insufficient evidence to conclude that deep NMB improves&#xD;
      surgical conditions during laparoscopic bariatric surgery.&#xD;
&#xD;
      In the recent literature, there is insufficient evidence to conclude that deep NMB improves&#xD;
      surgical conditions during laparoscopic bariatric surgery. However postoperative pulmonary&#xD;
      function was decreased independently of the depth of NMB regime. There are limited data on&#xD;
      the effect of such practices on postoperative outcomes especially in enhanced recovery after&#xD;
      bariatric anesthesia (ERABA) .A previous study by Unterbuchner C has showed deep NMB may&#xD;
      improve surgical conditions during low-pressure capnoperitoneium , However ,it has also been&#xD;
      reported by M.H. Bruintjes and his colleagues showed that the routine capnoperitoneium&#xD;
      insufflation pressure improved surgical conditions independent of the level of muscular&#xD;
      relaxation. Torensma B and his colleagues have reported that the previous pregnancy can&#xD;
      affects the abdominal wall strength and eventually the degree of relaxation Therefore, the&#xD;
      investigators have decided to exclude any females with previous history of pregnancy in the&#xD;
      study design and also report interaction between inhalation anesthetics and NMB, through&#xD;
      augmentation of the effect of NMB.&#xD;
&#xD;
      Martini and his colleagues showed that , rating of the quality of surgical conditions&#xD;
      considerably varies between different surgeons when assessed through&#xD;
      Leiden-Surgical-Rating-scale . Therefor in this study, the Lieden-surgical-score is going to&#xD;
      be used by the bariatric surgeon who is going to be the operating consultant in this study&#xD;
      population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2020</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>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Only the attending anesthesiologist and anesthesia assistant are going to be aware of the allocation in order to administer the required level of NMB</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Complete recovery in post anesthesia care unit (PACU) without residual curarization</measure>
    <time_frame>immediate postoperative in the PACU</time_frame>
    <description>clinical signs of recovery are met in the PACU</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complete recovery in the ward</measure>
    <time_frame>first postoperative day</time_frame>
    <description>clinical signs of recovery are met in the ward</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Bariatric Surgery Candidate</condition>
  <arm_group>
    <arm_group_label>group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Moderate neuromuscular blockade (NMB) , defined as a 1±2 twitch response to the train-of four (TOF) by stimulation of the ulnar nerve. The device which will be used is neuromuscular transmission monitor (NMT) to test the depth of muscle relaxation after giving rocuronium which is a muscle relaxant during general anesthesia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Deep NMB, defined by (0 twitch count in the TOF, 1±2 twitch responses in the post-tetanic count. The device which will be used is neuromuscular transmission monitor (NMT) to test the depth of muscle relaxation after giving rocuronium which is a muscle relaxant during general anesthesia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Neuromuscular transmission monitoring (NMT)</intervention_name>
    <description>NMT is to monitor the depth of neuromuscular blockade intensity</description>
    <arm_group_label>group A</arm_group_label>
    <arm_group_label>group B</arm_group_label>
    <other_name>NMT monitor the depth of muscle relaxation and based upon its reading Rocuronium which is muscle relaxant to be given to the patient under general anesthesia</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age older than 18 years.&#xD;
&#xD;
          2. Obese or morbidly obese as defined by a BMI &gt; 35 (kg/m2).&#xD;
&#xD;
          3. American Society of Anesthesiologists physical status class II, or III.&#xD;
&#xD;
          4. Presenting of Laparoscopic sleeve gastrectomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of allergy to Rocuronium or Sugammadex.&#xD;
&#xD;
          2. History of allergy to Dexamethasone, Ondansetron, Paracetamol, Fentanyl, Propofol,&#xD;
             Morphine or Tramadol.&#xD;
&#xD;
          3. Current or previous pregnancy.&#xD;
&#xD;
          4. History of renal impairment, (We are going to use the Cockcroft-Gault equation is the&#xD;
             gold standard for estimating renal function for the purposes of drug dosing cut off&#xD;
             point: CrCl/GFR=30ml/min) The GFR calculator is available at:&#xD;
             http://clincalc.com/Kinetics/CrCl.aspx?example&#xD;
&#xD;
          5. Patient on oxygen therapy , e,g CPAP&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ALHARBI</last_name>
    <role>Principal Investigator</role>
    <affiliation>KindSaudU</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>King Saud University College of Medicine and King Khalid University Hospital</name>
      <address>
        <city>Riyadh</city>
        <zip>11472</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King Saud University</investigator_affiliation>
    <investigator_full_name>Narjes Sultan AL-Otaibi</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rocuronium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>to be submit</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>i year</ipd_time_frame>
    <ipd_access_criteria>to be submit</ipd_access_criteria>
  </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/NCT04466943
org study id: E-19-3960
nct id: NCT04466943
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Most published articles suggest that deep neuromuscular blockade is required for bariatric
      surgery. However, the evidence for such practice is still inconclusive. From the clinical
      experience at a major bariatric center of volume exceeding six hundred procedures annually,
      the investigators believe that moderate neuromuscular blockade will provide an adequate
      surgical condition and significantly facilitate enhanced recovery after bariatric procedures.
Muscle relaxation is paramount for successful laparoscopic surgery. However the optimal
      degree of neuromuscular blockade (NMB) is not identified yet. Previous studies showed
      conflicting results on the outcomes of laparoscopic surgical conditions when moderate NMB was
      compared to deep blockade .The evidence for the use of either modalities is rather limited .
      In the recent literature, there is insufficient evidence to conclude that deep NMB improves
      surgical conditions during laparoscopic bariatric surgery.

      In the recent literature, there is insufficient evidence to conclude that deep NMB improves
      surgical conditions during laparoscopic bariatric surgery. However postoperative pulmonary
      function was decreased independently of the depth of NMB regime. There are limited data on
      the effect of such practices on postoperative outcomes especially in enhanced recovery after
      bariatric anesthesia (ERABA) .A previous study by Unterbuchner C has showed deep NMB may
      improve surgical conditions during low-pressure capnoperitoneium , However ,it has also been
      reported by M.H. Bruintjes and his colleagues showed that the routine capnoperitoneium
      insufflation pressure improved surgical conditions independent of the level of muscular
      relaxation. Torensma B and his colleagues have reported that the previous pregnancy can
      affects the abdominal wall strength and eventually the degree of relaxation Therefore, the
      investigators have decided to exclude any females with previous history of pregnancy in the
      study design and also report interaction between inhalation anesthetics and NMB, through
      augmentation of the effect of NMB.

      Martini and his colleagues showed that , rating of the quality of surgical conditions
      considerably varies between different surgeons when assessed through
      Leiden-Surgical-Rating-scale . Therefor in this study, the Lieden-surgical-score is going to
      be used by the bariatric surgeon who is going to be the operating consultant in this study
      population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Only the attending anesthesiologist and anesthesia assistant are going to be aware of the allocation in order to administer the required level of NMB
measure: Complete recovery in post anesthesia care unit (PACU) without residual curarization
time frame: immediate postoperative in the PACU
description: clinical signs of recovery are met in the PACU
measure: Complete recovery in the ward
time frame: first postoperative day
description: clinical signs of recovery are met in the ward
arm group label: group A
arm group type: Experimental
description: Moderate neuromuscular blockade (NMB) , defined as a 1±2 twitch response to the train-of four (TOF) by stimulation of the ulnar nerve. The device which will be used is neuromuscular transmission monitor (NMT) to test the depth of muscle relaxation after giving rocuronium which is a muscle relaxant during general anesthesia.
arm group label: group B
arm group type: Experimental
description: Deep NMB, defined by (0 twitch count in the TOF, 1±2 twitch responses in the post-tetanic count. The device which will be used is neuromuscular transmission monitor (NMT) to test the depth of muscle relaxation after giving rocuronium which is a muscle relaxant during general anesthesia.
intervention type: Device
intervention name: Neuromuscular transmission monitoring (NMT)
description: NMT is to monitor the depth of neuromuscular blockade intensity
arm group label: group A
arm group label: group B
other name: NMT monitor the depth of muscle relaxation and based upon its reading Rocuronium which is muscle relaxant to be given to the patient under general anesthesia
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: ALHARBI
role: Principal Investigator
affiliation: KindSaudU
facility: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: King Saud University
investigator full name: Narjes Sultan AL-Otaibi
investigator title: Principal Investigator
mesh term: Rocuronium
sharing ipd: Yes
ipd description: to be submit
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: i year
ipd access criteria: to be submit