The Effect of Deep Neuromuscular Blockade on Respiratory Mechanics

The Effect of Deep Neuromuscular Blockade During Robotic Assisted Radical Prostatectomy on Intraoperative Respiratory Mechanics and Postoperative Pulmonary Complications : a Prospective Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Neuromuscular Blockade
• Intervention / Treatment: Other: Moderate NMB; Other: Deep NMB

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 Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Moderate block; 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.	Other: Moderate NMB; Neuromuscular block was maintained at train of four count 1-2.
Experimental: Deep block; 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	Other: Deep NMB; Neuromuscular block was maintained at train of four count 0 and post-tetanic count1-2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak inspiratory pressure	measured through ventilator	until 1 hour after pneumoperitoneum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
plateau pressure	measured through ventilator	until 1 hour after pneumoperitoneum
dynamic lung compliance	Tidal volume/(Peak inspiratory pressure - PEEP)	until 1 hour after pneumoperitoneum
static lung compliance	Tidal volume/(Plateau pressure - PEEP)	until 1 hour after pneumoperitoneum
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
Postoperative pulmonary complications	SpO2 <90% or RR < 8/min, atelectasis confirmed by Chest X ray	postoperative 30 min

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Chang-Hoon Koo, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2019
• Primary Completion (Actual): August 30, 2020
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (Actual): November 22, 2019

Study Record Updates

• Last Update Posted (Actual): December 9, 2021
• Last Update Submitted That Met QC Criteria: December 7, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: RALP-PIP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No