Evaluation of Hemodynamic Changes Using Different IAP for... | NCT07055074

Studies
Evaluation of Hemodynamic Changes Using Different IAP for LC Under General Anesthesia

NCT07055074

Sponsor

Superior University

Status

Active, not recruiting

Last Update Posted

Jul 8, 2025Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Laparocele

Interventions

Low Pressure Pneumoperitoneum
Medium Pressure Pneumoperitoneum

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 17, 2025Actual

Primary Completion Date

Sep 1, 2025Estimated

Completion Date

Feb 28, 2026Estimated

First Submitted Date

Jun 26, 2025

First Submission Date that Met QC Criteria

Jul 3, 2025

First Posted Date

Jul 8, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2025

Last Update Posted Date

Jul 8, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low Pressure Pneumoperitoneum			Diagnostic Test: Low Pressure Pneumoperitoneum
Medium Pressure Pneumoperitoneum			Diagnostic Test: Medium Pressure Pneumoperitoneum

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Low Pressure Pneumoperitoneum	Diagnostic Test	Low Pressure Pneumoperitoneum (8-10 mmHg) Details: CO₂ insufflation to 8-10 mmHg IAP, continuous monitoring, measurement at baseline, insufflation, and desufflation.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Self Administered Questioner	Self-Administered Questionnaire for taking different values	12 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing laparoscopic cholecystectomy under general anesthesia
Age between 18-60 years
ASA physical status I-II
Provided informed consent

Exclusion Criteria:

History of cardiovascular or respiratory diseases or other Significant comorbidities affecting hemodynamic stability.
Pregnant patients
Allergies to anesthetic agents

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Hemodynamic stability, intra-abdominal pressure effects, physiological stress during laparoscopic cholecystectomy, cardiovascular and respiratory responses under general anesthesia.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pakistan Surgical Center, G9/4		Islamabad			Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided