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Muscle Relax Affects Outcomes of Robotic Surgery (MORE)

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ClinicalTrials.gov Identifier: NCT03726372
Recruitment Status : Not yet recruiting
First Posted : October 31, 2018
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Zhihong LU, Fourth Military Medical University

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.

Condition or disease Intervention/treatment Phase
General Anesthesia Postoperative Complications Drug: Rocuronium Other: continuous infusion Other: intermittent injection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Muscle relaxant will be given by a specific investigator that is not involved in anesthesia and outcome assessment
Primary Purpose: Prevention
Official Title: Effect of Neuromuscular Blockade Protocol on Perioperative Outcomes of Robotic Laparoscopic Surgery
Estimated Study Start Date : November 10, 2018
Estimated Primary Completion Date : November 10, 2019
Estimated Study Completion Date : November 10, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: deep neuromuscular blockade
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
Drug: Rocuronium
rocuronium is a neuromuscular blocking agent with a duration of 40 minutes
Other Name: rocuronium bromide

Other: continuous infusion
rocuronium is continuously infused
Other Name: high dose

Experimental: moderate neuromuscular blockade
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
Drug: Rocuronium
rocuronium is a neuromuscular blocking agent with a duration of 40 minutes
Other Name: rocuronium bromide

Other: intermittent injection
rocuronium is intermittently given
Other Name: low dose




Primary Outcome Measures :
  1. incidence of postoperative major respiratory complications [ Time Frame: from end of surgery to discharge, at an average of 4 days ]
    incidence of pneumonia and atelectasis


Secondary Outcome Measures :
  1. maximal airway pressure [ Time Frame: from establishment of pneumoperitoneum to end of pneumoperitoneum, at an average of 3 hours ]
    airway pressure is titrated to as low as possible as long as the end tidal carbon dioxide partial pressure is lower than 40 mmHg

  2. minimal cerebral oxygen saturation [ Time Frame: from start of surgery to end of surgery, at an average of 3.5 hours ]
    cerebral oxygen saturation is continuously monitored during surgery

  3. maximal intraocular pressure [ Time Frame: from start of surgery to end of surgery, at an average of 3.5 hours ]
    intraocular pressure is monitored every 10 minutes during surgery

  4. number of surgeon asking for improving muscle relax [ Time Frame: from start of surgery to end of surgery, at an average of 3.5 hours ]
    when the surgeon is unsatisfied with the muscle relax, he can tell the anesthetist

  5. time to extubation [ Time Frame: from end of sevoflurane inhalation to extubation, at an average of 20 minutes ]
    criteria of extubation: spontaneous respiratory rate>10 per minute and end tidal carbon dioxide partial pressure<45mmHg

  6. 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 ]
  7. incidence of shoulder pain in 24 hours after surgery [ Time Frame: from end of surgery to 24 hours after surgery ]
  8. incidence of residual neuromuscular blockade in the post-anesthesia care unit [ Time Frame: from admittance to post-anesthesia care unit(PACU) to discharge from PACU, at an average of 30 minutes ]
    residual neuromuscular blockade is defined as time of head-lift or limb-lift<10 seconds

  9. visual analogue scale at 24 hours after surgery [ Time Frame: end of surgery to 24 hours after surgery ]
    the patients are asked to mark the score they feel, 0 is no pain,100 is untolerated pain

  10. expense after surgery [ Time Frame: end of the surgery to discharge,at an average of 4 days ]
    the expense from immediately after surgery to discharge

  11. satisfaction score of the patients [ Time Frame: from end of surgery to discharge,at an average of 4 days ]
    the patient is asked to give a score between 0 and 10, 0 means not satisfied,10 means totally satisfied.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726372


Contacts
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Contact: Zhihong Lu 86-13891975018 ext 13891975018 deerlu23@163.com
Contact: Hailong Dong 86-84775337 ext 8613891975018 hldong6@hotmail.com

Sponsors and Collaborators
Fourth Military Medical University
Investigators
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Principal Investigator: Zhihong Lu Xijing Hospital

Publications:
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Responsible Party: Zhihong LU, principle investigator, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT03726372     History of Changes
Other Study ID Numbers: XJH-A-20180701
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After publishing, data of the primary endpoint and second endpoints can be shared with other researchers
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhihong LU, Fourth Military Medical University:
robotic surgery
laparoscopic surgery
neuromuscular blockade
postoperative complication
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes
Rocuronium
Neuromuscular Blocking Agents
Neuromuscular Nondepolarizing Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs