Moderate vs Deep Neuromuscular Block on Biotrauma During Laparoscopy

Ajou University School of Medicine

Status: Completed

Conditions: Pneumoperitoneum

Treatments: Drug: Deep neuromuscular block; Drug: Moderate neuromuscular block

Study type: Interventional

Funder types: Other

Identifiers

NCT03576118

AJIRB-MED-OBS-18-115

Details and patient eligibility

About

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.

Full 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).

Enrollment: 74 patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 2 patient groups

Deep neuromuscular block

Experimental group

Description:

Deep neuromuscular relaxation and low pressure pneumoperitoneum

Treatment:

Drug: Deep neuromuscular block

Moderate neuromuscular block

Active Comparator group

Description:

Moderate neuromuscular relaxation and standard pressure pneumoperitoneum

Treatment:

Drug: Moderate neuromuscular block