An interventional study of Moderate NMB and Deep NMB in Neuromuscular Blockade, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2021-12-09.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Prevention
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.
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.
Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Exclusion Criteria:
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
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
Neuromuscular block was maintained at train of four count 1-2.
Neuromuscular block was maintained at train of four count 0 and post-tetanic count1-2.
Peak inspiratory pressure
measured through ventilator
Time frame: until 1 hour after pneumoperitoneum
plateau pressure
measured through ventilator
Time frame: until 1 hour after pneumoperitoneum
dynamic lung compliance
Tidal volume/(Peak inspiratory pressure - PEEP)
Time frame: until 1 hour after pneumoperitoneum
static lung compliance
Tidal volume/(Plateau pressure - PEEP)
Time frame: 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)
Time frame: 1 min at the end of surgery
Postoperative pulmonary complications
SpO2 \<90% or RR \< 8/min, atelectasis confirmed by Chest X ray
Time frame: postoperative 30 min
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital