The Effect of Deep Neuromuscular Blockade on Respiratory Mechanics

Seoul National University

Status: Completed

Conditions: Neuromuscular Blockade

Treatments: Other: Moderate NMB; Other: Deep NMB

Study type: Interventional

Funder types: Other

Identifiers

NCT04174222

RALP-PIP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: Male

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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58 participants in 2 patient groups

Moderate block

Active Comparator group

Description:

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.

Treatment:

Other: Moderate NMB

Deep block

Experimental group

Description:

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

Treatment:

Other: Deep NMB