Regional Cerebral Oxygen Saturation in Laparoscopic Surgery

Study Overview
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Brief Summary
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While few studies have determined the optimal intra-abdominal CO2 insufflation pressure to achieve optimal surgical condition during LCs with deep-NMB and moderate-NMB in laparoscopic cholecystectomy (LC), previous studies suggested that the use of deep neuromuscular blockade (deep-NMB) can improve surgical condition and reduce the pressure for CO2 insufflation to achieve optimal surgical space condition. this difference in the pressure of intra-abdominal CO2 insufflation due to different strategies employing deep-NMB and moderate-NMB for LC may produce possible difference in patient's respiratory pattern and cerebral oxygenation. Although previous study (studies) showed that intra-abdominal CO2 insufflation (10-12 mmHg) decreases cerebral oxy-hemoglobin (HbO2) and total Hb measured by near-infrared spectroscopy (NIRS) during laparoscopic cholecystectomy (LC), few studies have speculated possible impact of different degree of NMB and intra-abdominal CO2 insufflation pressure on patient's cardiorespiratory profile and cerebral oxygenation, so far. The present study determines and compares the changes CO2 absorption and cerebral oxygenation (cerebral perfusion) after applying CO2 insufflation with different intra-peritoneal pressure 8 vs 12 mmHg during deep-NMB.

Official Title
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Impact of Neuromuscular Blockade on Cerebral Oxygen Saturation in Laparoscopic Surgery Employ Carbon Dioxide-pneumoperitoneum

Conditions
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Cholecyctitis

Intervention / Treatment
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* Procedure: CO2 insufflation at intra-abdominal pressure 8 mmHg
* Procedure: CO2 insufflation at intra-abdominal pressure 12 mmHg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: cholecystitis provision of written informed consent Exclusion Criteria: COPD asthma low LV ejection fraction

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: CO2 insufflation at intra-abdominal pressure 8 mmHg<br>CO2 insufflation with intra-abdominal pressure 8 mmHg during deep-NMB | Procedure: CO2 insufflation at intra-abdominal pressure 8 mmHg<br>* insufflation of CO2 gas into peritoneum for maintaining the pressure of 8 mmHg<br>|
| Active Comparator: CO2 insufflation at intra-abdominal pressure 12 mmHg<br>CO2 insufflation with intra-abdominal pressure 12 mmHg during deep-NMB | Procedure: CO2 insufflation at intra-abdominal pressure 12 mmHg<br>* insufflation of CO2 gas into peritoneum for maintaining the pressure of 12 mmHg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| regional cerebral oxygen saturation 1 | 1 min after the initiation of pneumoperitonium | 1 min | 
| regional cerebral oxygen saturation 2 | 2 min after the initiation of pneumoperitonium | 2 min | 
| regional cerebral oxygen saturation 3 | 2 min after the initiation of pneumoperitonium | 3 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| end-tidal carbon dioxide 1 |  | 1 min | 
| end-tidal carbon dioxide 2 |  | 2 min | 
| end-tidal carbon dioxide 3 |  | 3 min | 
| repiratory rate |  | 3 min |