Comparison of Intraoperative Hemodynamic Parameters and Arterial-blood Gas Changes at Two Different Pneumoperitoneal Pressure Values

Study Overview
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Brief Summary
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Clinic and metabolic consequences of pneumoperitoneum, achieved by insufflation of gas carbon dioxide, are still debated. Cardiovascular system suffering due to the compression of intra-abdominal venous structures can cause life-threatening complications. Increased partial pressure of carbon dioxide induces metabolic acidosis with further vascular suffering. Pneumoperitoneum reduces the pulmonary exchange volumes and bring renal suffering. Methods. The aim of this study is to evaluate the alterations in hemodynamic and hemogasanalysis parameters during the laparoscopic surgery at different pressure settings of pneumoperitoneum in order to assess the best pressure value. We evaluated and compared intraoperative hemodynamic and hemogasanalytic alterations in two groups of patients respectively subdue to laparoscopic cholecystectomy at a pneumoperitoneum pressure of 12 mmHg (group A) and at a pressure of 8 mmHg (group B).

Detailed Description
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We evaluated intraoperative hemodynamic and hemogasanalytic alterations in two groups of randomized patients respectively operated at a pneumoperitoneum pressure of 12 mmHg (group A) and at a pressure of 8 mmHg (group B) to highlight any significant alterations. The clinical sample used in the study is composed by patients aged between 15 and 85 years affected by cholelithiasis and treated with laparoscopic cholecystectomy in the period between July 2019 and February 2020. 20 patients, 9 men and 11 women, were enrolled. Group A included 10 patients, 5 men and 5 women, with an average age of 47.9 years. Group B included 10 patients, 4 men and 6 women, with an average age of 50.7 years. The parameters evaluated were: heart rate (HR), average arterial blood pressure (BP), respiratory frequency (RF), oxygen saturation (SaO2), hemogasanalysis (PaO2, PaCO2, pH and HCO3-). The measurements were made at four stages: before the induction of anesthesia, after the anesthesia induction but before incision, 30 minutes after the pneumoperitoneum induction, 5 minutes after the pneumoperitoneum releasing. The hemodynamic parameters (HR, RF, BP, SaO2) were extrapolated from the multiparameter monitor for each evaluation. The hemogasanalytic values (PaO2, PaCO2, pH and HCO3) were evaluated by the radial arterial sampling. The average and standard deviation were calculated for the quantitative data normally distributed. For the comparison of the quantitative data, the t-student test was used. A value of p ≤ 0,05 was considered statistically significant.

Official Title
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Laparoscopic Surgery: Comparison of Intraoperative Hemodynamic Parameters and Arterial-blood Gas Changes at Two Different Pneumoperitoneal Pressure Values

Conditions
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Pneumoperitoneum

Intervention / Treatment
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* Procedure: laparoscopic cholecystectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: cholelithiasis - Exclusion Criteria: immunodeficiency disorders, chronic use of corticosteroids, non-compensated diabetes mellitus, major morbidity with a life expectancy of less than 30 days, significant anemia (hemoglobin < 7 gr/Dl or hematocrit < 21%), coagulopathies, ascites, chronic pain treatment, severe comorbidities -

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 85 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>pneumoperitoneum pressure of 12 mmHg | Procedure: laparoscopic cholecystectomy<br>* removal of the gallbladder by laparoscopy at pneumoperitoneum pressure setting of 12 or 8 mmHg<br>|
| Group B<br>pneumoperitoneum pressure of 8 mmHg | Procedure: laparoscopic cholecystectomy<br>* removal of the gallbladder by laparoscopy at pneumoperitoneum pressure setting of 12 or 8 mmHg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hearth rate | hearth rate variations | before the induction of anesthesia | 
| hearth rate | hearth rate variations | after the anesthesia induction but before incision | 
| hearth rate | hearth rate variations | 30 minutes after the pneumoperitoneum induction | 
| hearth rate | hearth rate variations | 5 minutes after the pneumoperitoneum releasing | 
| arterial blood pressure | average arterial blood pressure variations | before the induction of anesthesia | 
| arterial blood pressure | average arterial blood pressure variations | after the anesthesia induction but before incision | 
| arterial blood pressure | average arterial blood pressure variations | 30 minutes after the pneumoperitoneum induction | 
| arterial blood pressure | average arterial blood pressure variations | 5 minutes after the pneumoperitoneum releasing | 
| respiratory frequency | respiratory frequency variations | before the induction of anesthesia | 
| respiratory frequency | respiratory frequency variations | after the anesthesia induction but before incision | 
| respiratory frequency | respiratory frequency variations | 30 minutes after the pneumoperitoneum induction | 
| respiratory frequency | respiratory frequency variations | 5 minutes after the pneumoperitoneum releasing | 
| oxygen saturation | oxygen saturation variations | before the induction of anesthesia | 
| oxygen saturation | oxygen saturation variations | after the anesthesia induction but before incision | 
| oxygen saturation | oxygen saturation variations | 30 minutes after the pneumoperitoneum induction | 
| oxygen saturation | oxygen saturation variations | 5 minutes after the pneumoperitoneum releasing | 
| blood gas analysis | blood gas analysis variations | before the induction of anesthesia | 
| blood gas analysis | blood gas analysis variations | after the anesthesia induction but before incision | 
| blood gas analysis | blood gas analysis variations | 30 minutes after the pneumoperitoneum induction | 
| blood gas analysis | blood gas analysis variations | 5 minutes after the pneumoperitoneum releasing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood gas analysis alterations; hemodynamic alterations