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Completed

NCT Number: NCT04174222

The Effect of Deep Neuromuscular Blockade on Respiratory Mechanics

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.

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Key information

Age range

19 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moderate NMB

Other

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

Deep NMB

Other

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

Primary outcomes

  1. Peak inspiratory pressure

    Time frame: until 1 hour after pneumoperitoneum

    measured through ventilator

Secondary outcomes

  1. plateau pressure

    Time frame: until 1 hour after pneumoperitoneum

    measured through ventilator

  2. dynamic lung compliance

    Time frame: until 1 hour after pneumoperitoneum

    Tidal volume/(Peak inspiratory pressure - PEEP)

  3. static lung compliance

    Time frame: until 1 hour after pneumoperitoneum

    Tidal volume/(Plateau pressure - PEEP)

  4. 5-point surgical rating scale

    Time frame: 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)

  5. Postoperative pulmonary complications

    Time frame: postoperative 30 min

    SpO2 <90% or RR < 8/min, atelectasis confirmed by Chest X ray

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Nov 22, 2019
Registry last updated
Dec 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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