Moderate vs Deep Neuromuscular Block on Biotrauma During Laparoscopy

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Pneumoperitoneum

Intervention / Treatment
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* Drug: Deep neuromuscular block
* Drug: Moderate neuromuscular block


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep neuromuscular block<br>Deep neuromuscular relaxation and low pressure pneumoperitoneum | Drug: Deep neuromuscular block<br>* Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum<br>* Other names: Deep neuromuscular block with rocumeron;|
| Active Comparator: Moderate neuromuscular block<br>Moderate neuromuscular relaxation and standard pressure pneumoperitoneum | Drug: Moderate neuromuscular block<br>* Moderate neuromuscular block using moderate dose rocuronium and 12-15 mmHg pneumoperitoneum<br>* Other names: Moderate neuromuscular block with rocumeron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Cytokine | change of IL-6 (pg/ml) | baseline, end of pneumoperitoneum, 24 hr after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biotrauma, laparoscopic surgery, neuromuscular block, sugammadex