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Muscle Relax Affects Outcomes of Robotic Surgery

Not Applicable
Conditions
Postoperative Complications
General Anesthesia
Interventions
Other: continuous infusion
Other: intermittent injection
Registration Number
NCT03726372
Lead Sponsor
Air Force Military Medical University, China
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
192
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
deep neuromuscular blockadeRocuroniumRocuronium, 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
deep neuromuscular blockadecontinuous infusionRocuronium, 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
moderate neuromuscular blockadeRocuroniumRocuronium, 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
moderate neuromuscular blockadeintermittent injectionRocuronium, 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
Primary Outcome Measures
NameTimeMethod
incidence of postoperative major respiratory complicationsfrom end of surgery to discharge, at an average of 4 days

incidence of pneumonia and atelectasis

Secondary Outcome Measures
NameTimeMethod
satisfaction score of the patientsfrom 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.

number of surgeon asking for improving muscle relaxfrom 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

incidence of shoulder pain in 24 hours after surgeryfrom end of surgery to 24 hours after surgery
time to extubationfrom 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

incidence of nausea and vomiting in post-anesthesia care unitfrom admittance to post-anesthesia care unit(PACU) to discharge from PACU, at an average of 30 minutes
incidence of residual neuromuscular blockade in the post-anesthesia care unitfrom 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

maximal airway pressurefrom 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

minimal cerebral oxygen saturationfrom start of surgery to end of surgery, at an average of 3.5 hours

cerebral oxygen saturation is continuously monitored during surgery

maximal intraocular pressurefrom start of surgery to end of surgery, at an average of 3.5 hours

intraocular pressure is monitored every 10 minutes during surgery

visual analogue scale at 24 hours after surgeryend 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

expense after surgeryend of the surgery to discharge,at an average of 4 days

the expense from immediately after surgery to discharge

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