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

Pneumoperitoneum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05367557
• Other study ID #: UCatania000
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: February 28, 2020

Study information

• Verified date: May 2022
• Source: University of Catania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 28, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 85 Years

Eligibility

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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Related Conditions & MeSH terms

• Pneumoperitoneum

Intervention

Procedure:
• laparoscopic cholecystectomy
removal of the gallbladder by laparoscopy at pneumoperitoneum pressure setting of 12 or 8 mmHg

Locations

Country	Name	City	State
Italy	Eva Intagliata	Catania

Sponsors (1)

Lead Sponsor	Collaborator
Eva Intagliata

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hearth rate	hearth rate variations	before the induction of anesthesia
Primary	hearth rate	hearth rate variations	after the anesthesia induction but before incision
Primary	hearth rate	hearth rate variations	30 minutes after the pneumoperitoneum induction
Primary	hearth rate	hearth rate variations	5 minutes after the pneumoperitoneum releasing
Primary	arterial blood pressure	average arterial blood pressure variations	before the induction of anesthesia
Primary	arterial blood pressure	average arterial blood pressure variations	after the anesthesia induction but before incision
Primary	arterial blood pressure	average arterial blood pressure variations	30 minutes after the pneumoperitoneum induction
Primary	arterial blood pressure	average arterial blood pressure variations	5 minutes after the pneumoperitoneum releasing
Primary	respiratory frequency	respiratory frequency variations	before the induction of anesthesia
Primary	respiratory frequency	respiratory frequency variations	after the anesthesia induction but before incision
Primary	respiratory frequency	respiratory frequency variations	30 minutes after the pneumoperitoneum induction
Primary	respiratory frequency	respiratory frequency variations	5 minutes after the pneumoperitoneum releasing
Primary	oxygen saturation	oxygen saturation variations	before the induction of anesthesia
Primary	oxygen saturation	oxygen saturation variations	after the anesthesia induction but before incision
Primary	oxygen saturation	oxygen saturation variations	30 minutes after the pneumoperitoneum induction
Primary	oxygen saturation	oxygen saturation variations	5 minutes after the pneumoperitoneum releasing
Primary	blood gas analysis	blood gas analysis variations	before the induction of anesthesia
Primary	blood gas analysis	blood gas analysis variations	after the anesthesia induction but before incision
Primary	blood gas analysis	blood gas analysis variations	30 minutes after the pneumoperitoneum induction
Primary	blood gas analysis	blood gas analysis variations	5 minutes after the pneumoperitoneum releasing