Clinical Trials Logo

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).


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05367557
Study type Observational
Source University of Catania
Contact
Status Completed
Phase
Start date July 1, 2019
Completion date February 28, 2020

See also
  Status Clinical Trial Phase
Active, not recruiting NCT06075836 - AI Assisted Detection of Chest X-Rays
Completed NCT03608436 - The Effect of Low Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on Early Quality of Recovery Phase 4
Completed NCT03572413 - The Effect of Low Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on Innate Immune Homeostasis. Phase 4
Completed NCT04146090 - Low-pressure vs Standard-pressure in Laparoscopic Cholecystectomy N/A
Completed NCT02853591 - Comparison of Pneumoinsufflation Modes and Pressure Settings in Gynecology N/A
Completed NCT03576118 - Moderate vs Deep Neuromuscular Block on Biotrauma During Laparoscopy N/A
Completed NCT02079337 - Validation of Subjective Rating Scales Used to Assess Surgical Conditions in Abdominal Surgery Phase 4
Completed NCT01512511 - Comparing Nitrous Oxide and Carbon Dioxide for Laparoscopic Cholecystectomy N/A
Not yet recruiting NCT06116383 - Evaluation of Renal Perfusion With NIRS in Laparoscopic Surgery
Withdrawn NCT03933254 - Intraocular Pressure and Optic Nerve Sheath Diameter Changes in Laparoscopic Cholecystectomies
Recruiting NCT03069586 - Effect Low Pressure Pneumoperitoneum and Pulmonary Recruitment on Postoperative Pain N/A
Recruiting NCT01867814 - Arterial and Plethysmographic Waveforms Variables as Predictors of Hemodynamic Response to Pneumoperitoneum N/A
Terminated NCT01854307 - The Influence of Pneumoperitoneum on Minimal Invasive Cardiac Output Measurements N/A
Completed NCT05992636 - Different Insufflation Flows and Effects on Cerebral Oxygenation in Laparoscopic Cholecystectomy
Completed NCT03957837 - Optical Nerve Sheath Changes During Head Down Laparoscopy
Recruiting NCT06319053 - The Turbine-based Insufflator Safety and Feasibility Study N/A
Completed NCT04125173 - Effect of Lower Pneumoperitoneum Pressure During Laparoscopic and Robotic Hysterectomy N/A
Not yet recruiting NCT02690688 - Intra-abdominal Pressure and Dynamic Preload Variables N/A
Completed NCT05238506 - Lidocaine VS Hemodynamic, Metabolic and Hormonal Response Phase 4
Completed NCT03928171 - The Effect of Intra-abdominal Pressure on Peritoneal Perfusion During Laparoscopic Colorectal Surgery N/A