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

Laparoscopic Surgery: 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).

Study Overview

• Status: Completed
• Conditions: Pneumoperitoneum
• Intervention / Treatment: Procedure: laparoscopic cholecystectomy

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Italy
  • Catania, Italy, 95123
    • Eva Intagliata

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 85 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients aged between 15 and 85 years affected by symptomatic cholelithiasis and treated with laparoscopic cholecystectomy

Description

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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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; pneumoperitoneum pressure of 12 mmHg	Procedure: laparoscopic cholecystectomy; removal of the gallbladder by laparoscopy at pneumoperitoneum pressure setting of 12 or 8 mmHg
Group B; pneumoperitoneum pressure of 8 mmHg	Procedure: laparoscopic cholecystectomy; removal of the gallbladder by laparoscopy at pneumoperitoneum pressure setting of 12 or 8 mmHg

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Eva Intagliata

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2019
• Primary Completion (ACTUAL): February 1, 2020
• Study Completion (ACTUAL): February 28, 2020

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (ACTUAL): May 10, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Blood gas analysis alterations; hemodynamic alterations
• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pneumoperitoneum
• Other Study ID Numbers: UCatania000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No