The Effect of Deep Neuromuscular Blockade During Robotic Assisted Radical Prostatectomy on Intraoperative Respiratory Mechanics and Postoperative Pulmonary Complications : a Prospective Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neuromuscular Blockade
- Sponsor
- Seoul National University Hospital
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Peak inspiratory pressure
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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
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.
Investigators
Chang-Hoon Koo
Assistant professor
Seoul National University Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Peak inspiratory pressure
Time Frame: until 1 hour after pneumoperitoneum
measured through ventilator
Secondary Outcomes
- 5-point surgical rating scale(1 min at the end of surgery)
- Postoperative pulmonary complications(postoperative 30 min)
- dynamic lung compliance(until 1 hour after pneumoperitoneum)
- plateau pressure(until 1 hour after pneumoperitoneum)
- static lung compliance(until 1 hour after pneumoperitoneum)