Moderate vs Deep Neuromuscular Block on Biotrauma During Laparoscopy

Not Applicable

Completed

• Conditions: Pneumoperitoneum
• Interventions: Drug: Deep neuromuscular block; Drug: Moderate neuromuscular block

• Registration Number: NCT03576118
• Lead Sponsor: Ajou University School of Medicine

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).

Study Timeline

• Study First Submitted: 2018-06-14
• Study First Submitted QC: 2018-06-22
• Study First Posted: 2018-07-03
• Study Start: 2018-11-05
• Primary Completion: 2019-07-12
• Study Completion: 2019-09-19
• Results First Submitted: 2020-03-28
• Status Verified: 2020-05
• Results First Submitted QC: 2020-05-31
• Last Update Submitted: 2020-05-31
• Results First Posted: 2020-06-11
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deep neuromuscular block	Deep neuromuscular block	Deep neuromuscular relaxation and low pressure pneumoperitoneum
Moderate neuromuscular block	Moderate neuromuscular block	Moderate neuromuscular relaxation and standard pressure pneumoperitoneum

Primary Outcome Measures

Name	Time	Method
Change of Cytokine	baseline, end of pneumoperitoneum, 24 hr after surgery	change of IL-6 (pg/ml)

Trial Locations

Locations (1)

Ajou University Hospital; 🇰🇷 Suwon, Gyeonggi-do, Korea, Republic of