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Muscle Relax Affects Outcomes of Robotic Surgery (MORE)

Primary Purpose

General Anesthesia, Postoperative Complications

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rocuronium
continuous infusion
intermittent injection
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for General Anesthesia focused on measuring robotic surgery, laparoscopic surgery, neuromuscular blockade, postoperative complication

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients scheduled for elective robotic laparoscopic surgery under general anesthesia
  • American Society of Anesthesiologists status 1-2
  • Body mass index of 18-30kg/m2
  • Patients scheduled to be positioned in trendelenburg position during surgery

Exclusion Criteria:

  • Patients allergic to rocuronium
  • Patients with neuromuscular dysfunction
  • Patients with existed pulmonary diseases
  • Patients with hepatic or renal dysfunction

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    deep neuromuscular blockade

    moderate neuromuscular blockade

    Arm Description

    Rocuronium, a neuromuscular blocking agent will be given by continuous infusion at a dose that reaction to train of four (TOF) stimulation is depressed to zero

    Rocuronium, a neuromuscular blocking agent will be given at a dose by intermittent injection that reaction to train of four (TOF) stimulation is kept 1 to 2

    Outcomes

    Primary Outcome Measures

    incidence of postoperative major respiratory complications
    incidence of pneumonia and atelectasis

    Secondary Outcome Measures

    maximal airway pressure
    airway pressure is titrated to as low as possible as long as the end tidal carbon dioxide partial pressure is lower than 40 mmHg
    minimal cerebral oxygen saturation
    cerebral oxygen saturation is continuously monitored during surgery
    maximal intraocular pressure
    intraocular pressure is monitored every 10 minutes during surgery
    number of surgeon asking for improving muscle relax
    when the surgeon is unsatisfied with the muscle relax, he can tell the anesthetist
    time to extubation
    criteria of extubation: spontaneous respiratory rate>10 per minute and end tidal carbon dioxide partial pressure<45mmHg
    incidence of nausea and vomiting in post-anesthesia care unit
    incidence of shoulder pain in 24 hours after surgery
    incidence of residual neuromuscular blockade in the post-anesthesia care unit
    residual neuromuscular blockade is defined as time of head-lift or limb-lift<10 seconds
    visual analogue scale at 24 hours after surgery
    the patients are asked to mark the score they feel, 0 is no pain,100 is untolerated pain
    expense after surgery
    the expense from immediately after surgery to discharge
    satisfaction score of the patients
    the patient is asked to give a score between 0 and 10, 0 means not satisfied,10 means totally satisfied.

    Full Information

    First Posted
    October 28, 2018
    Last Updated
    October 29, 2018
    Sponsor
    Air Force Military Medical University, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03726372
    Brief Title
    Muscle Relax Affects Outcomes of Robotic Surgery
    Acronym
    MORE
    Official Title
    Effect of Neuromuscular Blockade Protocol on Perioperative Outcomes of Robotic Laparoscopic Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 10, 2018 (Anticipated)
    Primary Completion Date
    November 10, 2019 (Anticipated)
    Study Completion Date
    November 10, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Air Force Military Medical University, China

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    During robotic laparoscopic surgery, a high intraperitoneal pressure may result in high airway pressure and inadequate perfusion of the abdominal organs, and as a result the postoperative outcomes. Degree of neuromuscular blockade (NMB) can affect the intraperitoneal pressure. In this study, the patients undergoing robotic laparoscopic surgery will be assigned to deep NMB group and moderate NMB group. Perioperative outcomes including maximal intraperitoneal pressure, maximal intraoptic pressure, quality of emergence, postoperative pain, and incidence of postoperative respiratory complication will be compared. The results of this study will provide evidence for optimizing NMB protocol of robotic laparoscopic surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    General Anesthesia, Postoperative Complications
    Keywords
    robotic surgery, laparoscopic surgery, neuromuscular blockade, postoperative complication

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Masking Description
    Muscle relaxant will be given by a specific investigator that is not involved in anesthesia and outcome assessment
    Allocation
    Randomized
    Enrollment
    192 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    deep neuromuscular blockade
    Arm Type
    Experimental
    Arm Description
    Rocuronium, a neuromuscular blocking agent will be given by continuous infusion at a dose that reaction to train of four (TOF) stimulation is depressed to zero
    Arm Title
    moderate neuromuscular blockade
    Arm Type
    Experimental
    Arm Description
    Rocuronium, a neuromuscular blocking agent will be given at a dose by intermittent injection that reaction to train of four (TOF) stimulation is kept 1 to 2
    Intervention Type
    Drug
    Intervention Name(s)
    Rocuronium
    Other Intervention Name(s)
    rocuronium bromide
    Intervention Description
    rocuronium is a neuromuscular blocking agent with a duration of 40 minutes
    Intervention Type
    Other
    Intervention Name(s)
    continuous infusion
    Other Intervention Name(s)
    high dose
    Intervention Description
    rocuronium is continuously infused
    Intervention Type
    Other
    Intervention Name(s)
    intermittent injection
    Other Intervention Name(s)
    low dose
    Intervention Description
    rocuronium is intermittently given
    Primary Outcome Measure Information:
    Title
    incidence of postoperative major respiratory complications
    Description
    incidence of pneumonia and atelectasis
    Time Frame
    from end of surgery to discharge, at an average of 4 days
    Secondary Outcome Measure Information:
    Title
    maximal airway pressure
    Description
    airway pressure is titrated to as low as possible as long as the end tidal carbon dioxide partial pressure is lower than 40 mmHg
    Time Frame
    from establishment of pneumoperitoneum to end of pneumoperitoneum, at an average of 3 hours
    Title
    minimal cerebral oxygen saturation
    Description
    cerebral oxygen saturation is continuously monitored during surgery
    Time Frame
    from start of surgery to end of surgery, at an average of 3.5 hours
    Title
    maximal intraocular pressure
    Description
    intraocular pressure is monitored every 10 minutes during surgery
    Time Frame
    from start of surgery to end of surgery, at an average of 3.5 hours
    Title
    number of surgeon asking for improving muscle relax
    Description
    when the surgeon is unsatisfied with the muscle relax, he can tell the anesthetist
    Time Frame
    from start of surgery to end of surgery, at an average of 3.5 hours
    Title
    time to extubation
    Description
    criteria of extubation: spontaneous respiratory rate>10 per minute and end tidal carbon dioxide partial pressure<45mmHg
    Time Frame
    from end of sevoflurane inhalation to extubation, at an average of 20 minutes
    Title
    incidence of nausea and vomiting in post-anesthesia care unit
    Time Frame
    from admittance to post-anesthesia care unit(PACU) to discharge from PACU, at an average of 30 minutes
    Title
    incidence of shoulder pain in 24 hours after surgery
    Time Frame
    from end of surgery to 24 hours after surgery
    Title
    incidence of residual neuromuscular blockade in the post-anesthesia care unit
    Description
    residual neuromuscular blockade is defined as time of head-lift or limb-lift<10 seconds
    Time Frame
    from admittance to post-anesthesia care unit(PACU) to discharge from PACU, at an average of 30 minutes
    Title
    visual analogue scale at 24 hours after surgery
    Description
    the patients are asked to mark the score they feel, 0 is no pain,100 is untolerated pain
    Time Frame
    end of surgery to 24 hours after surgery
    Title
    expense after surgery
    Description
    the expense from immediately after surgery to discharge
    Time Frame
    end of the surgery to discharge,at an average of 4 days
    Title
    satisfaction score of the patients
    Description
    the patient is asked to give a score between 0 and 10, 0 means not satisfied,10 means totally satisfied.
    Time Frame
    from end of surgery to discharge,at an average of 4 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients scheduled for elective robotic laparoscopic surgery under general anesthesia American Society of Anesthesiologists status 1-2 Body mass index of 18-30kg/m2 Patients scheduled to be positioned in trendelenburg position during surgery Exclusion Criteria: Patients allergic to rocuronium Patients with neuromuscular dysfunction Patients with existed pulmonary diseases Patients with hepatic or renal dysfunction
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhihong Lu
    Phone
    86-13891975018
    Ext
    13891975018
    Email
    deerlu23@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hailong Dong
    Phone
    86-84775337
    Ext
    8613891975018
    Email
    hldong6@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zhihong Lu
    Organizational Affiliation
    Xijing Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    After publishing, data of the primary endpoint and second endpoints can be shared with other researchers
    IPD Sharing Time Frame
    When the results have been published in peer-reviewed journals, the data will be available. The planned time frame will be 5 years.
    Citations:
    PubMed Identifier
    25684372
    Citation
    Van Wijk RM, Watts RW, Ledowski T, Trochsler M, Moran JL, Arenas GW. Deep neuromuscular block reduces intra-abdominal pressure requirements during laparoscopic cholecystectomy: a prospective observational study. Acta Anaesthesiol Scand. 2015 Apr;59(4):434-40. doi: 10.1111/aas.12491. Epub 2015 Feb 13.
    Results Reference
    background
    PubMed Identifier
    24240315
    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.
    Results Reference
    background
    PubMed Identifier
    28803124
    Citation
    Barrio J, Errando CL, Garcia-Ramon J, Selles R, San Miguel G, Gallego J. Influence of depth of neuromuscular blockade on surgical conditions during low-pressure pneumoperitoneum laparoscopic cholecystectomy: A randomized blinded study. J Clin Anesth. 2017 Nov;42:26-30. doi: 10.1016/j.jclinane.2017.08.005. Epub 2017 Aug 30.
    Results Reference
    background
    PubMed Identifier
    27936214
    Citation
    Torensma B, Martini CH, Boon M, Olofsen E, In 't Veld B, Liem RS, Knook MT, Swank DJ, Dahan A. Deep Neuromuscular Block Improves Surgical Conditions during Bariatric Surgery and Reduces Postoperative Pain: A Randomized Double Blind Controlled Trial. PLoS One. 2016 Dec 9;11(12):e0167907. doi: 10.1371/journal.pone.0167907. eCollection 2016.
    Results Reference
    background

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