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

Not Applicable

Completed

• Conditions: Brain Ischemia
• Interventions: Other: PEEP; Other: ZEEP

• Registration Number: NCT01443962
• Lead Sponsor: Gachon University Gil Medical Center

Brief Summary

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)

Detailed Description

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.

Study Timeline

• Study First Submitted: 2011-09-27
• Study First Submitted QC: 2011-09-29
• Study First Posted: 2011-09-30
• Study Start: 2011-11
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-02
• Last Update Posted: 2013-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Zero positive end expiratory pressure	PEEP	Number: 30, apply no PEEP during the pneumoperitoneum during the laparoscopic cholecystectomy PEEP was not applied whole investigation period
positive end expiratory pressure	ZEEP	applying PEEP 10 cmH2O during pneumoperitoneum continuously

Primary Outcome Measures

Name	Time	Method
change in regional brain oxygen saturation	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

Trial Locations

Locations (1)

Hyun Jeong Kwak; 🇰🇷 Incheon, Korea, Republic of