Hemodynamic Changes Study During Laparoscopic Cholecystectomy
This observational study is examining changes in blood flow and pressure during laparoscopic gallbladder removal surgery, using a self-administered questionnaire to gather information.
Data Collection
Collected from past medical records and data - RetrospectiveCase-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Summary
Study start date: March 17, 2025
Actual date on which the first participant was enrolled.This study focuses on patients undergoing laparoscopic cholecystectomy, a common and less invasive surgery to remove the gallbladder. During this procedure, carbon dioxide (CO₂) is used to inflate the abdomen, creating space for the surgery by increasing intra-abdominal pressure. The study aims to understand how different levels of this pressure affect the body's heart rate, blood pressure, oxygen levels, breathing rate, and carbon dioxide levels. This is important because finding the optimal pressure level could improve patient safety and recovery by minimizing potential negative effects on the heart and lungs. Participants in this study will undergo laparoscopic cholecystectomy under general anesthesia, with different groups experiencing varying levels of intra-abdominal pressure: low (8-10 mmHg), medium (12-14 mmHg), and high (15-20 mmHg). The researchers will monitor and measure changes in heart rate, blood pressure, oxygen saturation, respiratory rate, and end-tidal CO₂— a measure of the carbon dioxide released at the end of an exhaled breath. Data will be collected through self-administered questionnaires, allowing for an assessment of the physiological changes associated with each pressure level. This approach helps identify the safest and most effective pressure settings for such surgeries.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.150 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location