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Clinical Trials/NCT03576118
NCT03576118
Completed
Not Applicable

The Effects of Moderate Versus Deep Neuromuscular Block on Respiratory Mechanics and Biotrauma in Patients With Intraoperative Protective Lung Ventilation for Laparoscopy

Ajou University School of Medicine1 site in 1 country74 target enrollmentNovember 5, 2018

Overview

Phase
Not Applicable
Intervention
Deep neuromuscular block
Conditions
Pneumoperitoneum
Sponsor
Ajou University School of Medicine
Enrollment
74
Locations
1
Primary Endpoint
Change of Cytokine
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The purposes of this study is to investigate the effects of moderate vs. deep neuromuscular block on respiratory mechanics and biotrauma in patients with intraoperative protective lung ventilation for laparoscopy.

Detailed Description

Mechanical ventilation results in the disruption of the alveolar-capillary barrier and increased permeability, a hallmark of experimental ventilator-induced lung injury. These mechanical forces also induce an increase in the concentrations of inflammatory cytokines. The benefits of deep neuromuscular blocks for laparoscopic procedures are controversial and most of the studies undertaken have only sought to improve surgical conditions. Theoretically, deep neuromuscular block permits a lower abdominal insufflation pressure, which leads to better respiratory mechanics and gas exchange. The investigators examined the effects of moderate vs. deep neuromuscular block on respiratory mechanics and biotrauma in patients with intraoperative protective lung ventilation for laparoscopy. The investigators hypothesized that deep neuromuscular block (PTC 1 or 2) and low pressure pneumoperitoneum (8 mmHg) would improve respiratory mechanics and reduce inflammatory processes associated with biotrama during mechanical ventilation compared with moderate neuromuscular block (TOF count 1 or 2 ) and standard pressure pneumoperitoneum (12-15 mmHg).

Registry
clinicaltrials.gov
Start Date
November 5, 2018
End Date
September 19, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ajou University School of Medicine
Responsible Party
Principal Investigator
Principal Investigator

Jong Yeop Kim

Professor

Ajou University School of Medicine

Eligibility Criteria

Inclusion Criteria

  • ASA physical status I or II, aged 25 to 80 years, scheduled for laparoscopic surgery with trendelenburg position

Exclusion Criteria

  • cerebrovascular disease
  • uncontrolled hypertension, asthma, COPD
  • neuromuscular disorder
  • patients who have had abdominal surgery
  • morbid obesity (body mass index \> 35 kg/m2)

Arms & Interventions

Deep neuromuscular block

Deep neuromuscular relaxation and low pressure pneumoperitoneum

Intervention: Deep neuromuscular block

Moderate neuromuscular block

Moderate neuromuscular relaxation and standard pressure pneumoperitoneum

Intervention: Moderate neuromuscular block

Outcomes

Primary Outcomes

Change of Cytokine

Time Frame: baseline, end of pneumoperitoneum, 24 hr after surgery

change of IL-6 (pg/ml)

Study Sites (1)

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