The Effect of Deep Neuromuscular Blockade on Respiratory Mechanics

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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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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