Clinical trial NCT04174222: The Effect of Deep Neuromuscular Blockade on Respiratory Mechanics
Official title: The Effect of Deep Neuromuscular Blockade During Robotic Assisted Radical Prostatectomy on Intraoperative Respiratory Mechanics and Postoperative Pulmonary Complications : a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuromuscular Blockade
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 58
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Peak inspiratory pressure
timeFrame: until 1 hour after pneumoperitoneum
Secondary outcomes:
measure: plateau pressure
timeFrame: until 1 hour after pneumoperitoneum
measure: dynamic lung compliance
timeFrame: until 1 hour after pneumoperitoneum
measure: static lung compliance
timeFrame: until 1 hour after pneumoperitoneum
measure: 5-point surgical rating scale
timeFrame: 1 min at the end of surgery
measure: Postoperative pulmonary complications
timeFrame: postoperative 30 min
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Chang-Hoon Koo
role: PRINCIPAL_INVESTIGATOR
References: