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NCT Number: NCT07055074

Evaluation of Hemodynamic Changes Using Different IAP for LC 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Laparocele

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pakistan Surgical Center, G9/4

Islamabad, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Medium Pressure Pneumoperitoneum

Diagnostic 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.

Primary outcomes

  1. Self Administered Questioner

    Time frame: 12 Months

    Self-Administered Questionnaire for taking different values

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Official study title

Evaluation of Hemodynamic Changes Using Different Intra-Abdominal Pressures for Laparoscopic Cholecystectomy Under General Anesthesia

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 8, 2025
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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