The Effect of Deep Neuromuscular Blockade on Respiratory Mechanics

Not Applicable

Completed

• Conditions: Neuromuscular Blockade
• Interventions: Other: Deep NMB; Other: Moderate NMB

• Registration Number: NCT04174222
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2019-11-21
• Study First Submitted QC: 2019-11-21
• Study Start: 2019-11-22
• Study First Posted: 2019-11-22
• Primary Completion: 2020-08-30
• Study Completion: 2021-06-30
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-07
• Last Update Posted: 2021-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deep block	Deep 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
Moderate block	Moderate NMB	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.

Primary Outcome Measures

Name	Time	Method
Peak inspiratory pressure	until 1 hour after pneumoperitoneum	measured through ventilator

Secondary Outcome Measures

Name	Time	Method
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
dynamic lung compliance	until 1 hour after pneumoperitoneum	Tidal volume/(Peak inspiratory pressure - PEEP)
plateau pressure	until 1 hour after pneumoperitoneum	measured through ventilator
static lung compliance	until 1 hour after pneumoperitoneum	Tidal volume/(Plateau pressure - PEEP)

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of