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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01443962
Other study ID # GIRBA 2568
Secondary ID
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


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
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