The Effect of Deep Neuromuscular Blockade on Respiratory Mechanics

Study Overview
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Brief Summary
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This study is a randomized, controlled, double-blinded, and parallel design study. A total 58 patients were randomized to receive a deep block or a moderate block scheduled for elective robot assisted laparoscopic radical prostatectomy. Intraoperative peak inspiratory pressure and plateau pressure are assessed.

Detailed Description
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Patients >18 years of age with an america society of anesthesiologist classification of I or II who are scheduled to undergo elective robot assisted laparoscopic radical prostatectomy are included. The exclusion criteria are a history of neuromuscular, renal, or hepatic disease, known allergy to rocuronium or sugammadex. Patients are randomized to either the moderate or deep neuromuscular blockade group using Random Allocation Software (version 1.0). In the operating room, routine monitoring is performed, including electrocardiography, non-invasive arterial pressure measurements, and pulse oximetry. Additionally, acceleromyography are applied to monitor the response of the adductor pollicis muscle. After the induction of anesthesia with propofol and before rocuronium administration, the TOF-Watch-SX is calibrated and stabilised, and a series of train-of-four (TOF) measurements are documented every 1 min. Next, intravenous rocuronium at 0.6 mg/kg was administered, and tracheal intubation was performed after confirmation of relaxation. Anesthesia is maintained with desflurane and target-controlled infusion of remifentanil while monitoring the bispectral index. Intravenous rocuronium (5-10 mg) is used to maintain moderate (TOF count of 1 or 2) or deep (post-tetanic count [PTC] of 1 or 2) neuromuscular blockade. Peak inspiratory pressure and plateau pressure are recorded until 1 hour after pneumoperitoneum. At the end of the operation, the surgeon rated the surgical condition on a 5-point scale. Patients are reversed with intravenous sugammadex at 2 or 4 mg/kg. Postoperative pulmonary complications (SpO2 <100%, RR<8, atelectasis) are assessed and recorded.

Official Title
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The Effect of Deep Neuromuscular Blockade During Robotic Assisted Radical Prostatectomy on Intraoperative Respiratory Mechanics and Postoperative Pulmonary Complications : a Prospective Randomized Controlled Trial

Conditions
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Neuromuscular Blockade

Intervention / Treatment
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* Other: Moderate NMB
* Other: Deep NMB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who undergo elective robot assisted radical prostatectomy, American Society of Anesthesiologists grade 1 or 2 Exclusion Criteria: Refuse to participate to the study history of neuromuscular diseases known allergy to rocuronium, sugammadex patients scheduled for intensive care unit transfer Body Mass Index > 30 kg/m2 Severe renal function impairment Moderete or severe obstructive/restrictive lung disease

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Male

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 |
| --- | --- |
| Active Comparator: Moderate block<br>5-10mg rocuronium is administered to maintain train-of-four count 1-2. At the end of surgery, sugammadex 2mg/kg is administered IV for reversal of neuromuscular block. | Other: Moderate NMB<br>* Neuromuscular block was maintained at train of four count 1-2.<br>|
| Experimental: Deep block<br>5-10mg rocuronium is administered to maintain train-of-four count 0, and post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block | Other: Deep NMB<br>* Neuromuscular block was maintained at train of four count 0 and post-tetanic count1-2.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak inspiratory pressure | measured through ventilator | until 1 hour after pneumoperitoneum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plateau pressure | measured through ventilator | until 1 hour after pneumoperitoneum | 
| dynamic lung compliance | Tidal volume/(Peak inspiratory pressure - PEEP) | until 1 hour after pneumoperitoneum | 
| static lung compliance | Tidal volume/(Plateau pressure - PEEP) | until 1 hour after pneumoperitoneum | 
| 5-point surgical rating scale | Rated by the surgeon who is in charge of the patient's operation and is blind to the patient's group assignment. (1 = excellent, 2 = good, 3 = acceptable, 4 = poor, 5 = extremely poor) | 1 min at the end of surgery | 
| Postoperative pulmonary complications | SpO2 <90% or RR < 8/min, atelectasis confirmed by Chest X ray | postoperative 30 min |