Neuromuscular Blockade
Conditions
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.
Interventions
OTHERModerate NMB
Neuromuscular block was maintained at train of four count 1-2.
OTHERDeep NMB
Neuromuscular block was maintained at train of four count 0 and post-tetanic count1-2.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak inspiratory pressure | until 1 hour after pneumoperitoneum | measured through ventilator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| plateau pressure | until 1 hour after pneumoperitoneum | measured through ventilator |
| dynamic lung compliance | until 1 hour after pneumoperitoneum | Tidal volume/(Peak inspiratory pressure - PEEP) |
| static lung compliance | until 1 hour after pneumoperitoneum | Tidal volume/(Plateau pressure - PEEP) |
| 5-point surgical rating scale | 1 min at the end of surgery | 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) |
| Postoperative pulmonary complications | postoperative 30 min | SpO2 \<90% or RR \< 8/min, atelectasis confirmed by Chest X ray |
Countries
South Korea
Outcome results
None listed