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
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
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
NCT ID
NCT03726372
First Posted
October 28, 2018
Last Updated
October 29, 2018
Sponsor
Air Force Military Medical University, China
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
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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
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Muscle Relax Affects Outcomes of Robotic Surgery
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