The Effect of Deep Neuromuscular Blockade on Respiratory Mechanics

Neuromuscular Blockade Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04174222
• Other study ID #: RALP-PIP
• Status: Completed
• Phase: N/A
• Start date: November 22, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: December 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: June 30, 2021
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Other:
• Moderate NMB
Neuromuscular block was maintained at train of four count 1-2.
• Deep NMB
Neuromuscular block was maintained at train of four count 0 and post-tetanic count1-2.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak inspiratory pressure	measured through ventilator	until 1 hour after pneumoperitoneum
Secondary	plateau pressure	measured through ventilator	until 1 hour after pneumoperitoneum
Secondary	dynamic lung compliance	Tidal volume/(Peak inspiratory pressure - PEEP)	until 1 hour after pneumoperitoneum
Secondary	static lung compliance	Tidal volume/(Plateau pressure - PEEP)	until 1 hour after pneumoperitoneum
Secondary	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)	1 min at the end of surgery
Secondary	Postoperative pulmonary complications	SpO2 <90% or RR < 8/min, atelectasis confirmed by Chest X ray	postoperative 30 min