Suspended

Hemodynamic Changes Study During Laparoscopic Cholecystectomy

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Study Aim

This observational study is examining changes in blood flow and pressure during laparoscopic gallbladder removal surgery, using a self-administered questionnaire to gather information.

What is being collected

Data Collection

Collected from past medical records and data - Retrospective
Who is being recruted

From 18 to 60 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: March 2025
See protocol details

Summary

Principal SponsorSuperior University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleEvaluation of Hemodynamic Changes Using Different Intra-Abdominal Pressures for Laparoscopic Cholecystectomy Under General Anesthesia
NCT07055074
Principal SponsorSuperior University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

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

4 inclusion criteria required to participate
Patients undergoing laparoscopic cholecystectomy under general anesthesia

Age between 18-60 years

ASA physical status I-II

Provided informed consent

3 exclusion criteria prevent from participating
History of cardiovascular or respiratory diseases or other Significant comorbidities affecting hemodynamic stability.

Pregnant patients

Allergies to anesthetic agents

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

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

Suspended

Pakistan Surgical Center, G9/4

Islamabad, PakistanOpen Pakistan Surgical Center, G9/4 in Google Maps
SuspendedOne Study Center