Skip to main content
OpenTrials
Completed

NCT Number: NCT03576118

Moderate vs Deep Neuromuscular Block on Biotrauma During Laparoscopy

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

deep neuromuscular block

Drug

Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum

Other names: Deep neuromuscular block with rocumeron

Moderate neuromuscular block

Drug

Moderate neuromuscular block using moderate dose rocuronium and 12-15 mmHg pneumoperitoneum

Other names: Moderate neuromuscular block with rocumeron

Primary outcomes

  1. Change of Cytokine

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

    change of IL-6 (pg/ml)

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 3, 2018
Registry last updated
Jun 11, 2020

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.

Published trials that share one or more normalized conditions with this study.