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NCT Number: NCT05367557

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

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).

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Key information

Conditions

Pneumoperitoneum Digestive System Diseases Peritoneal Diseases

Age range

15 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Eva Intagliata

Catania, 95123, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Laparoscopic cholecystectomy

Procedure

removal of the gallbladder by laparoscopy at pneumoperitoneum pressure setting of 12 or 8 mmHg

Primary outcomes

  1. hearth rate

    Time frame: before the induction of anesthesia

    hearth rate variations

  2. hearth rate

    Time frame: after the anesthesia induction but before incision

    hearth rate variations

  3. hearth rate

    Time frame: 30 minutes after the pneumoperitoneum induction

    hearth rate variations

  4. hearth rate

    Time frame: 5 minutes after the pneumoperitoneum releasing

    hearth rate variations

  5. arterial blood pressure

    Time frame: before the induction of anesthesia

    average arterial blood pressure variations

  6. arterial blood pressure

    Time frame: after the anesthesia induction but before incision

    average arterial blood pressure variations

  7. arterial blood pressure

    Time frame: 30 minutes after the pneumoperitoneum induction

    average arterial blood pressure variations

  8. arterial blood pressure

    Time frame: 5 minutes after the pneumoperitoneum releasing

    average arterial blood pressure variations

  9. respiratory frequency

    Time frame: before the induction of anesthesia

    respiratory frequency variations

  10. respiratory frequency

    Time frame: after the anesthesia induction but before incision

    respiratory frequency variations

  11. respiratory frequency

    Time frame: 30 minutes after the pneumoperitoneum induction

    respiratory frequency variations

  12. respiratory frequency

    Time frame: 5 minutes after the pneumoperitoneum releasing

    respiratory frequency variations

  13. oxygen saturation

    Time frame: before the induction of anesthesia

    oxygen saturation variations

  14. oxygen saturation

    Time frame: after the anesthesia induction but before incision

    oxygen saturation variations

  15. oxygen saturation

    Time frame: 30 minutes after the pneumoperitoneum induction

    oxygen saturation variations

  16. oxygen saturation

    Time frame: 5 minutes after the pneumoperitoneum releasing

    oxygen saturation variations

  17. blood gas analysis

    Time frame: before the induction of anesthesia

    blood gas analysis variations

  18. blood gas analysis

    Time frame: after the anesthesia induction but before incision

    blood gas analysis variations

  19. blood gas analysis

    Time frame: 30 minutes after the pneumoperitoneum induction

    blood gas analysis variations

  20. blood gas analysis

    Time frame: 5 minutes after the pneumoperitoneum releasing

    blood gas analysis variations

Sponsors and collaborators

Lead sponsor

Eva Intagliata

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 10, 2022
Registry last updated
May 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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