Clinical trial NCT05367557: Comparison of Intraoperative Hemodynamic Parameters and Arterial-blood Gas Changes at Two Different Pneumoperitoneal Pressure Values
Official title: Laparoscopic Surgery: Comparison of Intraoperative Hemodynamic Parameters and Arterial-blood Gas Changes at Two Different Pneumoperitoneal Pressure Values
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumoperitoneum
Keywords: Blood gas analysis alterations; hemodynamic alterations
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients aged between 15 and 85 years affected by symptomatic cholelithiasis and treated with laparoscopic cholecystectomy

Brief summary: 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: 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.

Eligibility criteria: 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

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Primary outcomes:
measure: hearth rate
timeFrame: before the induction of anesthesia
measure: hearth rate
timeFrame: after the anesthesia induction but before incision
measure: hearth rate
timeFrame: 30 minutes after the pneumoperitoneum induction
measure: hearth rate
timeFrame: 5 minutes after the pneumoperitoneum releasing
measure: arterial blood pressure
timeFrame: before the induction of anesthesia
measure: arterial blood pressure
timeFrame: after the anesthesia induction but before incision
measure: arterial blood pressure
timeFrame: 30 minutes after the pneumoperitoneum induction
measure: arterial blood pressure
timeFrame: 5 minutes after the pneumoperitoneum releasing
measure: respiratory frequency
timeFrame: before the induction of anesthesia
measure: respiratory frequency
timeFrame: after the anesthesia induction but before incision
measure: respiratory frequency
timeFrame: 30 minutes after the pneumoperitoneum induction
measure: respiratory frequency
timeFrame: 5 minutes after the pneumoperitoneum releasing
measure: oxygen saturation
timeFrame: before the induction of anesthesia
measure: oxygen saturation
timeFrame: after the anesthesia induction but before incision
measure: oxygen saturation
timeFrame: 30 minutes after the pneumoperitoneum induction
measure: oxygen saturation
timeFrame: 5 minutes after the pneumoperitoneum releasing
measure: blood gas analysis
timeFrame: before the induction of anesthesia
measure: blood gas analysis
timeFrame: after the anesthesia induction but before incision
measure: blood gas analysis
timeFrame: 30 minutes after the pneumoperitoneum induction
measure: blood gas analysis
timeFrame: 5 minutes after the pneumoperitoneum releasing
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Eva Intagliata
Study officials:
References: