LaparoceleNCT07055074
Evaluation of Hemodynamic Changes Using Different IAP for LC Under General Anesthesia
An observational study of Laparocele, run by Superior University at 1 site in Pakistan.
Trial summary
This cross-sectional observational study aims to evaluate the hemodynamic changes induced by different intra-abdominal pressures (IAP) during laparoscopic cholecystectomy under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Laparocele
- What is being tested?
- Low Pressure Pneumoperitoneum and Medium Pressure Pneumoperitoneum
- How many people
- 150 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Mar 2025to 28 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Hemodynamic stability, intra-abdominal pressure effects, physiological stress during laparoscopic cholecystectomy, cardiovascular and respiratory responses under general anesthesia.
Who may be able to join
- Patients undergoing laparoscopic cholecystectomy under general anesthesia
- Age between 18-60 years
- ASA physical status I-II
- Provided informed consent
Who cannot join
- History of cardiovascular or respiratory diseases or other Significant comorbidities affecting hemodynamic stability.
- Pregnant patients
- Allergies to anesthetic agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Hemodynamic Changes Using Different Intra-Abdominal Pressures for Laparoscopic Cholecystectomy Under General Anesthesia
This cross-sectional observational study aims to evaluate the hemodynamic changes induced by different intra-abdominal pressures (IAP) during laparoscopic cholecystectomy under general anesthesia.
Read the detailed description
Laparoscopic cholecystectomy, a minimally invasive surgery, requires CO₂ insufflation to create a pneumoperitoneum, which alters intra-abdominal pressure and can affect cardiovascular and respiratory stability. This study assesses how varying IAP levels (8-10 mmHg, 12-14 mmHg, and 15-20 mmHg) influence heart rate, blood pressure, oxygen saturation, respiratory rate, and end-tidal CO₂.
- Conditions
- Laparocele
- Being tested
- Low Pressure Pneumoperitoneum, Medium Pressure Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Pressure PneumoperitoneumDiagnostic test
Low Pressure Pneumoperitoneum (8-10 mmHg) Details: CO₂ insufflation to 8-10 mmHg IAP, continuous monitoring, measurement at baseline, insufflation, and desufflation.
Medium Pressure PneumoperitoneumDiagnostic test
Medium Pressure Pneumoperitoneum (12-14 mmHg) Details: CO₂ insufflation to 12-14 mmHg IAP, parameters measured at key intervals, standard general anesthesia used. High Pressure Pneumoperitoneum (15-20 mmHg) Details: Standard high-pressure technique, monitoring of hemodynamic and respiratory parameters.
| Study group | Role | What they receive |
|---|---|---|
| Low Pressure Pneumoperitoneum | Not described Receives: Diagnostic Test: Low Pressure Pneumoperitoneum | |
| Medium Pressure Pneumoperitoneum | Not described Receives: Diagnostic Test: Medium Pressure Pneumoperitoneum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self Administered Questioner
Self-Administered Questionnaire for taking different values
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start17 Mar 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparoceleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055074
- Sponsor's protocol ID
- MSAHSW/Batch-Fall23/918
- Status last verified
- Jul 2025
- First submitted
- 26 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hemodynamic Changes Using Different Intra-Abdominal Pressures for Laparoscopic Cholecystectomy Under General Anesthesia
- ClinicalTrials.gov ID
- NCT07055074
- Acronym / sponsor ID
- MSAHSW/Batch-Fall23/918
- Conditions
- Laparocele
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This cross-sectional observational study aims to evaluate the hemodynamic changes induced by different intra-abdominal pressures (IAP) during laparoscopic cholecystectomy under general anesthesia.
Detailed description
Laparoscopic cholecystectomy, a minimally invasive surgery, requires CO₂ insufflation to create a pneumoperitoneum, which alters intra-abdominal pressure and can affect cardiovascular and respiratory stability. This study assesses how varying IAP levels (8-10 mmHg, 12-14 mmHg, and 15-20 mmHg) influence heart rate, blood pressure, oxygen saturation, respiratory rate, and end-tidal CO₂.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Pressure Pneumoperitoneum | – | Diagnostic Test: Low Pressure Pneumoperitoneum |
| Medium Pressure Pneumoperitoneum | – | Diagnostic Test: Medium Pressure Pneumoperitoneum |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Hemodynamic stability, intra-abdominal pressure effects, physiological stress during laparoscopic cholecystectomy, cardiovascular and respiratory responses under general anesthesia.
Key inclusion criteria (4 listed)
- Patients undergoing laparoscopic cholecystectomy under general anesthesia
- Age between 18-60 years
- ASA physical status I-II
- Provided informed consent
Key exclusion criteria (3 listed)
- History of cardiovascular or respiratory diseases or other Significant comorbidities affecting hemodynamic stability.
- Pregnant patients
- Allergies to anesthetic agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Pressure PneumoperitoneumLow Pressure Pneumoperitoneum (8-10 mmHg) Details: CO₂ insufflation to 8-10 mmHg IAP, continuous monitoring, measurement at baseline, insufflation, and desufflation. | Diagnostic test | Low Pressure Pneumoperitoneum |
| Medium Pressure PneumoperitoneumMedium Pressure Pneumoperitoneum (12-14 mmHg) Details: CO₂ insufflation to 12-14 mmHg IAP, parameters measured at key intervals, standard general anesthesia used. High Pressure Pneumoperitoneum (15-20 mmHg) Details: Standard high-pressure technique, monitoring of hemodynamic and respiratory parameters. | Diagnostic test | Medium Pressure Pneumoperitoneum |
Primary outcome
Self Administered Questioner
Time frame: 12 Months
Self-Administered Questionnaire for taking different values
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparocele, run by Superior University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self Administered Questioner (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.