The Effect of Deep Neuromuscular Blockade on Respiratory Mechanics

NCT ID: NCT04174222

Last Updated: 2021-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-22
• Study Completion Date: 2021-06-30

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.

Conditions

Neuromuscular Blockade

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Moderate NMB

Intervention Type: OTHER

Neuromuscular block was maintained at train of four count 1-2.

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

Group Type: EXPERIMENTAL

Deep NMB

Intervention Type: OTHER

Neuromuscular block was maintained at train of four count 0 and post-tetanic count1-2.

Interventions

Moderate NMB

Neuromuscular block was maintained at train of four count 1-2.

Intervention Type: OTHER

Deep NMB

Neuromuscular block was maintained at train of four count 0 and post-tetanic count1-2.

Intervention Type: OTHER

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chang-Hoon Koo

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chang-Hoon Koo

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

RALP-PIP

Identifier Type: -

Identifier Source: org_study_id