Pressure Support Ventilation During Laparoscopic and Abdominal Robotic Surgery.

Study Overview
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Brief Summary
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This study is a single-center, blind, prospective, randomized, controlled trial of pressure support ventilation (PSVpro) versus pressure control ventilation - volume guaranteed (PCV - VG) during laparoscopic and robotic abdominal surgery.

Detailed Description
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The objective of the study to evaluate the possibility and feasibility of using PSVpro during anesthesia during long-term laparoscopic and robot-assisted abdominal operations at different levels of neuromuscular block. Intervention: We plan to include 100 patients who will undergo elective long (more 2 hours) laparoscopic or abdominal robotic surgery. All patients will be randomly assigned in two groups in ratio 1:1. 1 group- deep neuromuscular block and mandatory ventilation; 2 group- partial neuromuscular block and pressure support ventilation. Expected Results. PSV may reduce the systemic inflammatory response compared to the mandatory ventilation during laparoscopic and abdominal robotic surgery.

Official Title
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Pressure Support Ventilation During Laparoscopic and Abdominal Robotic Surgery.

Conditions
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Ventilator-Induced Lung Injury

Intervention / Treatment
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* Procedure: Mandatory ventilation
* Procedure: pressure support ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Written consent. Men and women aged 18 years or more. The physical status from ASA classification I, II or III. BMI <= 34.9 kg / m2. Low risk of respiratory complications. Laparoscopic surgery in the pelvis. Exclusion criteria: The physical status from ASA IV or V. BMI> = 35 kg / m2. Neuromuscular disease. Allergy to Anesthetic Agents. Operations on two cavities. Operations on the chest cavity.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: t is planned to recruit patients in two groups: group 1-patients who will undergo General anesthesia with deep neuromuscular block and PCV-VG; group 2-patients with partial neuromuscular block and PSVpro. Randomization of patients into two 1:1 groups will be performed by random number generation.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mandatory ventilation<br>deep neuromuscular block and mandatory ventilation (PCV-VG); | Procedure: Mandatory ventilation<br>* Use PCV-VG<br>|
| Experimental: Pressure support ventilation<br>partial neuromuscular block and pressure support ventilation (PSVpro). | Procedure: pressure support ventilation<br>* Use PSVpro<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentrations of biomarkers of lung injury | Measure concentration of Interleukin-6 (IL-6), Interleukin-8 (IL-8), tumor necrosis factor receptor I / II (sTNF rI / II)) in blood serum | 1-3 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum intraoperative lactate level in the early postoperative period | Maximum intraoperative lactate level | 1 hour after surgery | 
| The maximum level of vasopressor support during surgery | Norepinephrine consumption (mcg/kg/h) | From time of skin incision to time of skin closure assessed up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pressure support ventilation, anaesthesia, lung injury, laparoscopic surgery