NCT07055074

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 8, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

June 26, 2025

Last Update Submit

July 3, 2025

Conditions

Laparocele

Outcome Measures

Primary Outcomes (1)

  • Self Administered Questioner

    Self-Administered Questionnaire for taking different values

    12 Months

Study Arms (2)

Low Pressure Pneumoperitoneum

Diagnostic Test: Low Pressure Pneumoperitoneum

Medium Pressure Pneumoperitoneum

Diagnostic Test: Medium Pressure Pneumoperitoneum

Interventions

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.

Low Pressure Pneumoperitoneum
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.

Medium Pressure Pneumoperitoneum

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Surgical Center, G9/4

Islamabad, Pakistan

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 26, 2025

First Posted

July 8, 2025

Study Start

March 17, 2025

Primary Completion

September 1, 2025

Study Completion

February 28, 2026

Last Updated

July 8, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)