<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/NCT03803982</url>
  </required_header>
  <id_info>
    <org_study_id>low pressure pneumoperitoneum</org_study_id>
    <nct_id>NCT03803982</nct_id>
  </id_info>
  <brief_title>Deep Neuromuscular Relaxation Optimizing Low-Pressure Bariatric Surgery</brief_title>
  <official_title>Deep Neuromuscular Relaxation Optimizing Low-Pressure Bariatric Surgery: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McMaster University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study aims to evaluate the use of deep neuromuscular blockade and low-pressure&#xD;
      pneumoperitoneum in bariatric surgery. The investigators propose to conduct a double-blind&#xD;
      randomized controlled trial (RCT) comparing deep neuromuscular blockade versus standard&#xD;
      blockade, and its impact on operative conditions during bariatric surgery. This trial will be&#xD;
      conducted at one of the highest volume bariatric centers in Canada. This study also aims to&#xD;
      examine the effects of deep neuromuscular blockade on patient-relevant outcomes, including&#xD;
      postoperative pain and narcotic use. The investigators anticipate this study will facilitate&#xD;
      the continual improvement of care provided to a growing number of bariatric patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a double-blind randomized controlled trial comparing patients undergoing a deep&#xD;
      neuromuscular blockade with a paralytic reversal agent versus patients undergoing standard&#xD;
      anesthetic protocols in low-pressure pneumoperitoneum bariatric surgery. The study population&#xD;
      will include patients aged 18-65 referred to St. Joseph's Healthcare for Roux-en-Y Gastric&#xD;
      Bypass (RYGB) after completion of standard work-up for bariatric surgery through the Ontario&#xD;
      Bariatric Network (OBN). The investigators plan to recruit and randomize 100 patients in a&#xD;
      1:1 ratio between deep NMB and standard anesthetic in low-pressure pneumoperitoneum bariatric&#xD;
      surgery. Once enrolled in the study, patients will be assigned to one of the two groups using&#xD;
      computer-based randomization on REDCap software. Allocation will be concealed until the time&#xD;
      of the operation and will be provided directly to the anesthetist in opaque envelopes. The&#xD;
      anesthetist will be aware of the assigned group, but the patient, surgeon, PACU nurses, ward&#xD;
      nurses, research assistants and house staff will be blinded. The primary outcomes to be&#xD;
      examined will include maximum intra-abdominal pressure, Leiden-Surgical Rating Scale, and&#xD;
      postoperative pain scores. Secondary outcomes will include operative time, postoperative&#xD;
      nausea, postoperative narcotic use, and length of stay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>The investigators propose to conduct a double-blind RCT comparing deep neuromuscular blockade to standard blockade during bariatric surgery. Participants will be randomized to one of the two groups in a 1:1 ratio.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The patients, surgeons, ward and PACU nurses, research assistants, and surgical house-staff will be blinded to the randomization. The anesthesiologist will be aware of the randomization as this will directly impact the anesthetic delivered to the patients.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum IAP</measure>
    <time_frame>Intraoperatively</time_frame>
    <description>Maximum Intra-Abdominal Pressure, as assessed by the degree of pneumoperitoneum for each position (supine and reverse Trendelenburg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Leiden-Surgical Rating Scale</measure>
    <time_frame>Intraoperatively</time_frame>
    <description>Assessment of operating conditions, as assessed by the surgeon, assessed at the beginning of each position change (supine and reverse Trendelenburg). Scale ranges from 1 (extremely poor operating conditions) to 5 (optimal conditions).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative Pain</measure>
    <time_frame>Post Operative Day 1</time_frame>
    <description>Postoperative pain as reported by the patient. Pain will be assessed on post operative day 1 at 8 am, noon, and 8pm, and an average pain score will then be calculated for post operative day 1. Pain will be assessed on an 11-point scale ranging from 0 (no pain) to 10 (most pain imaginable)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Operative Time</measure>
    <time_frame>Intraoperative</time_frame>
    <description>Two operative times will be recorded. The first will be related strictly to the surgery, from time of Veress needle insertion to time of removal of the final port. In addition, total operative time will also be recorded which will include time of induction and reversal of anesthesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Nausea</measure>
    <time_frame>Postoperative nausea scores will be recorded at 8 am, 2 pm, and 8pm on post operative day 1. Nausea will be measured on an 11-point scale ranging from 0 (no nausea) to 10 (most nausea imaginable).</time_frame>
    <description>Postoperative nausea as reported by the patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Narcotic Use</measure>
    <time_frame>During index admission, up to one week.</time_frame>
    <description>Amount of narcotic used by the patient postoperative</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Stay</measure>
    <time_frame>During index admission; through study completion, an average of 5 days</time_frame>
    <description>Length of stay</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Bariatric Surgery</condition>
  <arm_group>
    <arm_group_label>Deep Neuromuscular Blockade, Sugammadex</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients will receive anesthetic induction and maintenance as per routine using a combination of propofol, opioids, dexamethasone, and 0.6 mg/kg of rocuronium for induction. Patients will also receive lidocaine 1 mg/kg/hour IV infusion, followed by 3-5 mg of morphine equivalents prior to extubation. Patient monitoring will be according to local practice and consist of electrocardiography, blood pressure, heart rate and bispectral index monitoring. Neuromuscular function will be monitored every 20 minutes using a standardized nerve monitor. After induction and intubation, patients in the Deep Neuromuscular Blockade group (experimental group) will receive additional rocuronium to achieve a NMB blockade of TOF of 0 twitch and maintained at this level until reversal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Anesthetic</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in the standard anesthetic (or control group) will also receive anesthetic induction as per routine using a combination of propofol, opioids, dexamethasone, and rocuronium, with a lidocaine infusion. Patient monitoring will be similar to the experimental group, with electrocardiography, blood pressure, heart rate, and bispectral index monitoring. Patients in the control group will receive rocuronium 30 mg intravenous prior to intubation, followed by repeated 10 mg doses to reach a TOF of 1-2 twitches.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Deep Neuromuscular Blockade</intervention_name>
    <description>The proposed intervention in this study is delivery of an anesthetic with Deep Neuromuscular Blockage (NMB), which will be defined as a TOF of 0 and 2-3 twitches in the post-tetanic count.</description>
    <arm_group_label>Deep Neuromuscular Blockade, Sugammadex</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sugammadex</intervention_name>
    <description>Sugammadex will be used to reverse the deep neuromuscular blockade in the experimental group.</description>
    <arm_group_label>Deep Neuromuscular Blockade, Sugammadex</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient meets NIH criteria for bariatric surgery and has not received a previous&#xD;
             bariatric surgical procedure&#xD;
&#xD;
          -  The patient is aged 18-65 years and has completed the screening and preparation&#xD;
             process prescribed by the Ontario Bariatric Network&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
&#xD;
          -  ASA &gt; 4&#xD;
&#xD;
          -  Planned procedure other than RYGB or contraindications to RYGB&#xD;
&#xD;
          -  BMI &gt; 55 kg/m2&#xD;
&#xD;
          -  Revisional procedure&#xD;
&#xD;
          -  Allergies or suspected allergies to anesthetic medications (rocuronium or sugammadex)&#xD;
&#xD;
          -  Renal insufficiency (GFR &lt; 30ml/min)&#xD;
&#xD;
          -  Family or personal history of malignant hyperthermia or personal history of&#xD;
             neuromuscular disease&#xD;
&#xD;
          -  History of chronic pain needing daily medications for the last &gt;3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dennis Hong, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre for Minimal Access Surgery</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dennis Hong, MD, MSc</last_name>
    <phone>905-522-1155</phone>
    <phone_ext>32938</phone_ext>
    <email>dennishong70@gmail.com</email>
  </overall_contact>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 11, 2019</last_update_submitted>
  <last_update_submitted_qc>January 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McMaster University</investigator_affiliation>
    <investigator_full_name>Dennis Hong MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual Participant Data will not be shared</ipd_description>
  </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/NCT03803982
org study id: low pressure pneumoperitoneum
nct id: NCT03803982
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate the use of deep neuromuscular blockade and low-pressure
      pneumoperitoneum in bariatric surgery. The investigators propose to conduct a double-blind
      randomized controlled trial (RCT) comparing deep neuromuscular blockade versus standard
      blockade, and its impact on operative conditions during bariatric surgery. This trial will be
      conducted at one of the highest volume bariatric centers in Canada. This study also aims to
      examine the effects of deep neuromuscular blockade on patient-relevant outcomes, including
      postoperative pain and narcotic use. The investigators anticipate this study will facilitate
      the continual improvement of care provided to a growing number of bariatric patients.
This will be a double-blind randomized controlled trial comparing patients undergoing a deep
      neuromuscular blockade with a paralytic reversal agent versus patients undergoing standard
      anesthetic protocols in low-pressure pneumoperitoneum bariatric surgery. The study population
      will include patients aged 18-65 referred to St. Joseph's Healthcare for Roux-en-Y Gastric
      Bypass (RYGB) after completion of standard work-up for bariatric surgery through the Ontario
      Bariatric Network (OBN). The investigators plan to recruit and randomize 100 patients in a
      1:1 ratio between deep NMB and standard anesthetic in low-pressure pneumoperitoneum bariatric
      surgery. Once enrolled in the study, patients will be assigned to one of the two groups using
      computer-based randomization on REDCap software. Allocation will be concealed until the time
      of the operation and will be provided directly to the anesthetist in opaque envelopes. The
      anesthetist will be aware of the assigned group, but the patient, surgeon, PACU nurses, ward
      nurses, research assistants and house staff will be blinded. The primary outcomes to be
      examined will include maximum intra-abdominal pressure, Leiden-Surgical Rating Scale, and
      postoperative pain scores. Secondary outcomes will include operative time, postoperative
      nausea, postoperative narcotic use, and length of stay.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The investigators propose to conduct a double-blind RCT comparing deep neuromuscular blockade to standard blockade during bariatric surgery. Participants will be randomized to one of the two groups in a 1:1 ratio.
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: The patients, surgeons, ward and PACU nurses, research assistants, and surgical house-staff will be blinded to the randomization. The anesthesiologist will be aware of the randomization as this will directly impact the anesthetic delivered to the patients.
measure: Maximum IAP
time frame: Intraoperatively
description: Maximum Intra-Abdominal Pressure, as assessed by the degree of pneumoperitoneum for each position (supine and reverse Trendelenburg)
measure: Leiden-Surgical Rating Scale
time frame: Intraoperatively
description: Assessment of operating conditions, as assessed by the surgeon, assessed at the beginning of each position change (supine and reverse Trendelenburg). Scale ranges from 1 (extremely poor operating conditions) to 5 (optimal conditions).
measure: Postoperative Pain
time frame: Post Operative Day 1
description: Postoperative pain as reported by the patient. Pain will be assessed on post operative day 1 at 8 am, noon, and 8pm, and an average pain score will then be calculated for post operative day 1. Pain will be assessed on an 11-point scale ranging from 0 (no pain) to 10 (most pain imaginable)
measure: Operative Time
time frame: Intraoperative
description: Two operative times will be recorded. The first will be related strictly to the surgery, from time of Veress needle insertion to time of removal of the final port. In addition, total operative time will also be recorded which will include time of induction and reversal of anesthesia
measure: Postoperative Nausea
time frame: Postoperative nausea scores will be recorded at 8 am, 2 pm, and 8pm on post operative day 1. Nausea will be measured on an 11-point scale ranging from 0 (no nausea) to 10 (most nausea imaginable).
description: Postoperative nausea as reported by the patient
measure: Postoperative Narcotic Use
time frame: During index admission, up to one week.
description: Amount of narcotic used by the patient postoperative
measure: Length of Stay
time frame: During index admission; through study completion, an average of 5 days
description: Length of stay
arm group label: Deep Neuromuscular Blockade, Sugammadex
arm group type: Experimental
description: All patients will receive anesthetic induction and maintenance as per routine using a combination of propofol, opioids, dexamethasone, and 0.6 mg/kg of rocuronium for induction. Patients will also receive lidocaine 1 mg/kg/hour IV infusion, followed by 3-5 mg of morphine equivalents prior to extubation. Patient monitoring will be according to local practice and consist of electrocardiography, blood pressure, heart rate and bispectral index monitoring. Neuromuscular function will be monitored every 20 minutes using a standardized nerve monitor. After induction and intubation, patients in the Deep Neuromuscular Blockade group (experimental group) will receive additional rocuronium to achieve a NMB blockade of TOF of 0 twitch and maintained at this level until reversal.
arm group label: Standard Anesthetic
arm group type: No Intervention
description: Patients in the standard anesthetic (or control group) will also receive anesthetic induction as per routine using a combination of propofol, opioids, dexamethasone, and rocuronium, with a lidocaine infusion. Patient monitoring will be similar to the experimental group, with electrocardiography, blood pressure, heart rate, and bispectral index monitoring. Patients in the control group will receive rocuronium 30 mg intravenous prior to intubation, followed by repeated 10 mg doses to reach a TOF of 1-2 twitches.
intervention type: Procedure
intervention name: Deep Neuromuscular Blockade
description: The proposed intervention in this study is delivery of an anesthetic with Deep Neuromuscular Blockage (NMB), which will be defined as a TOF of 0 and 2-3 twitches in the post-tetanic count.
arm group label: Deep Neuromuscular Blockade, Sugammadex
intervention type: Drug
intervention name: Sugammadex
description: Sugammadex will be used to reverse the deep neuromuscular blockade in the experimental group.
arm group label: Deep Neuromuscular Blockade, Sugammadex
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Dennis Hong, MD, MSc
role: Principal Investigator
affiliation: Centre for Minimal Access Surgery
last name: Dennis Hong, MD, MSc
phone: 905-522-1155
phone ext: 32938
email: dennishong70@gmail.com
responsible party type: Principal Investigator
investigator affiliation: McMaster University
investigator full name: Dennis Hong MD
investigator title: Principal Investigator
sharing ipd: No
ipd description: Individual Participant Data will not be shared