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

Brain Ischemia Clinical Trial

— lapaPEEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01443962
• Other study ID #: GIRBA 2568
• Status: Completed
• Phase: N/A
• First received: September 27, 2011
• Last updated: February 2, 2013
• Start date: November 2011
• Est. completion date: March 2012

Study information

• Verified date: February 2013
• Source: Gachon University Gil Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Brain Ischemia

Intervention

Other:
• PEEP
applying PEEP 0 cmH2O during pneumoperitoneum continuously
• ZEEP
applying PEEP 10 cmH2O during pneumoperitoneum continuously

Locations

Country	Name	City	State
Korea, Republic of	Hyun Jeong Kwak	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in regional brain oxygen saturation	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	from baseline record rSO2 every 10 minutes	No