Muscle Relax Affects Outcomes of Robotic Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Neuromuscular Blockade Protocol on Perioperative Outcomes of Robotic Laparoscopic Surgery

Conditions
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General Anesthesia, Postoperative Complications

Intervention / Treatment
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* Drug: Rocuronium
* Other: continuous infusion
* Other: intermittent injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: deep neuromuscular blockade<br>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<br>* rocuronium is a neuromuscular blocking agent with a duration of 40 minutes<br>* Other names: rocuronium bromide;Other: continuous infusion<br>* rocuronium is continuously infused<br>* Other names: high dose;|
| Experimental: moderate neuromuscular blockade<br>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<br>* rocuronium is a neuromuscular blocking agent with a duration of 40 minutes<br>* Other names: rocuronium bromide;Other: intermittent injection<br>* rocuronium is intermittently given<br>* Other names: low dose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of postoperative major respiratory complications | incidence of pneumonia and atelectasis | from end of surgery to discharge, at an average of 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | from establishment of pneumoperitoneum to end of pneumoperitoneum, at an average of 3 hours | 
| minimal cerebral oxygen saturation | cerebral oxygen saturation is continuously monitored during surgery | from start of surgery to end of surgery, at an average of 3.5 hours | 
| maximal intraocular pressure | intraocular pressure is monitored every 10 minutes during surgery | from start of surgery to end of surgery, at an average of 3.5 hours | 
| number of surgeon asking for improving muscle relax | when the surgeon is unsatisfied with the muscle relax, he can tell the anesthetist | from start of surgery to end of surgery, at an average of 3.5 hours | 
| time to extubation | criteria of extubation: spontaneous respiratory rate>10 per minute and end tidal carbon dioxide partial pressure<45mmHg | from end of sevoflurane inhalation to extubation, at an average of 20 minutes | 
| incidence of nausea and vomiting in post-anesthesia care unit |  | from admittance to post-anesthesia care unit(PACU) to discharge from PACU, at an average of 30 minutes | 
| incidence of shoulder pain in 24 hours after surgery |  | from end of surgery to 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 | from admittance to post-anesthesia care unit(PACU) to discharge from PACU, at an average of 30 minutes | 
| 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 | end of surgery to 24 hours after surgery | 
| expense after surgery | the expense from immediately after surgery to discharge | end of the surgery to discharge,at an average of 4 days | 
| 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. | from end of surgery to discharge,at an average of 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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robotic surgery, laparoscopic surgery, neuromuscular blockade, postoperative complication