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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mandatory ventilation | Active Comparator | deep neuromuscular block and mandatory ventilation (PCV-VG); |
|
| Pressure support ventilation | Experimental | partial neuromuscular block and pressure support ventilation (PSVpro). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mandatory ventilation | Procedure | Use PCV-VG |
| |
| pressure support ventilation |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of anaesthesia. | Duration of anaesthesia. | Period of time from induction to volatile anesthetic supply stop assessed up to 24 hours |
| Procedure time | Length of ventilation |
Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moscow Clinical Scientific Center | Moscow | Russia |
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| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013898 | Thoracic Injuries |
| D014947 | Wounds and Injuries |
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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.
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| Procedure |
Use PSVpro |
|
| From time of skin incision to time of skin closure assessed up to 24 hours |
| Period of time from intubation to extubation assessed up to 24 hours |
| Length of stay (LOS) in the intensive care unit (ICU). | Length of stay (LOS) in the intensive care unit (ICU). | Period of time from ICU arrival to discharge from ICU assessed up to 1 year |
| Time to reach an Aldrete score > 9 points after anaesthesia | Time to reach an Aldrete score > 9 points after anaesthesia | Period of time from volatile anesthetic suplly stop to time when patient has more than 9 points according Aldrete score assessed up to 24 hours |
| Intraoperative consumption of muscle relaxant | mg/kg of muscle relaxant | Since skin incision to skin closure assessed up to 24 hours |
| Intraoperative consumption of reversal agents. | mg/kg of reversal agents. | Since skin incision to skin closure assessed up to 24 hours |
| Supplemental oxygen in the early postoperative period | Duration of oxygen supply | Since extubation up to 24 hours after extubation |
| Quality of recovery score-40 | The QoR-40 incorporates five dimensions of health: patient support, comfort, emotions, physical independence, and pain; each item is graded on a five-point Likert scale. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). | 24 hours after surgery |
| Changes of spirometry parameter FVC after surgery | FVC before surgery (L) - FVC after surgery (L) | 1 hour and 24 hours after surgery |
| Changes of spirometry parameter FEV1 after surgery | FEV1 before surgery (L)- FEV1 after surgery (L) | 1 hour and 24 hours after surgery |
| Changes of spirometry parameter FEV1/FVC after surgery | FEV1/FVC before surgery (percentage %) - FEV1/FVC after surgery (percentage %) | 1 hour and 24 hours after surgery |
| Changes of spirometry parameter PEF after surgery | PEF before surgery (L/s) - PEF after surgery (L/s) | 1 hour and 24 hours after surgery |
| Changes of spirometry parameter VC after surgery | VC before surgery (L) - VC after surgery (L) | 1 hour and 24 hours after surgery |
| Changes of spirometry parameter FEV1/VC after surgery | FEV1/VC before surgery (percentage %) - FEV1/VC after surgery (percentage %) | 1 hour and 24 hours after surgery |
| Volume of atelectasis of lungs after surgery | Volume of the lungs measure according to CT lung The volume of atelectasis is the difference in volumes of lungs before and after surgery | 24 hours after surgery |
| The level of pain assess after surgery by Numeric Rating Scale (NRS) | No pain - 0, worst pain - 10 | 1 hour after surgery |
| The level of pain assess after surgery by Numeric Rating Scale (NRS) | No pain - 0, worst pain - 10 | 3 hours after surgery |
| The level of pain assess after surgery by Numeric Rating Scale (NRS) | No pain - 0, worst pain - 10 | 24 hours after surgery |
| Length of stay (LOS) in hospital | Length of stay (LOS) in hospital | 28 days |