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Completed

NCT Number: NCT01443962

The Effect of Positive End Expiratory Pressure (PEEP) During Laparoscopic Cholecystectomy

During the laparoscopic cholecystectomy, Pneumoperitoneum could affect to the regional oxygen saturation of brain. positive end expiratory pressure (PEEP)could improve the respiratory parameters include oxygenation. So applying PEEP could improve the regional brain oxygen saturation (rSO2)

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Key information

Conditions

Brain Ischemia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hyun Jeong Kwak

Incheon, South Korea

About this study

During the laparoscopic cholecystectomy, Pneumoperitoneum could affect to the regional oxygen saturation of brain due to increased intracranial pressure, central venous pressure and make worse to respiratory parameters. Positive end expiratory pressure could improve the respiratory parameters include oxygenation. So applying PEEP could improve the regional oxygen saturation of brain during the pneumoperitoneum during the laparoscopic cholecystectomy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA I or II,
  • 20-65 year,
  • patient who undergoing laparoscopic cholecystectomy

Exclusion criteria

  • cerebrovascular disease,
  • coronary artery disease,
  • morbid obesity (BMI > 30)
  • propofol allergy,
  • addictive

Treatment and study plan

PEEP

Other

applying PEEP 0 cmH2O during pneumoperitoneum continuously

Other names: PEEP 0

ZEEP

Other

applying PEEP 10 cmH2O during pneumoperitoneum continuously

Other names: PEEP 10

Primary outcomes

  1. change in regional brain oxygen saturation

    Time frame: from baseline record rSO2 every 10 minutes

    FiO2 0.6, Tidal vlume 8 ml/IBW (kg), PEEP 10 cm H2O or not, respiratory rate as end-tidal carbone dioxide concentration (ETCO2). During the peumoperitoneum record rSO2 every 10 minutes with respiratory parameters (Peak pressure, mean pressure, PEEP) and vital signs

Sponsors and collaborators

Lead sponsor

Gachon University Gil Medical Center

Other

Registry information

Official study title

The Effect of PEEP on Regional Cerebral Oxygen Saturation During Laparoscopic Cholecystectomy

Acronym: lapaPEEP

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 30, 2011
Registry last updated
Feb 5, 2013

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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