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

NCT05367557 | Completed DMC

• 1 other identifier: UCatania000
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Pneumoperitoneum

Keywords

Blood gas analysis alterations; hemodynamic alterations

Outcome Measures

Primary Outcomes (20)

• 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

Study Arms (2)

Group A

pneumoperitoneum pressure of 12 mmHg

Procedure: laparoscopic cholecystectomy

Group B

pneumoperitoneum pressure of 8 mmHg

Procedure: laparoscopic cholecystectomy

Interventions

laparoscopic cholecystectomy PROCEDURE

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

Group A; Group B

Eligibility Criteria

• Age: 15 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

Sponsors & Collaborators

• Eva Intagliata: lead

Study Sites (1)

Eva Intagliata

Catania, 95123, Italy

Location

MeSH Terms

Conditions

Pneumoperitoneum

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: researcher

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: May 10, 2022
• Study Start: July 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 28, 2020
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)