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Clinical Trials/NCT04174222
NCT04174222
Completed
Not Applicable

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

Seoul National University Hospital1 site in 1 country58 target enrollmentNovember 22, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neuromuscular Blockade
Sponsor
Seoul National University Hospital
Enrollment
58
Locations
1
Primary Endpoint
Peak inspiratory pressure
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 22, 2019
End Date
June 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chang-Hoon Koo

Assistant professor

Seoul National University Hospital

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

Outcomes

Primary Outcomes

Peak inspiratory pressure

Time Frame: until 1 hour after pneumoperitoneum

measured through ventilator

Secondary Outcomes

  • 5-point surgical rating scale(1 min at the end of surgery)
  • Postoperative pulmonary complications(postoperative 30 min)
  • dynamic lung compliance(until 1 hour after pneumoperitoneum)
  • plateau pressure(until 1 hour after pneumoperitoneum)
  • static lung compliance(until 1 hour after pneumoperitoneum)

Study Sites (1)

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