Comparison of Oxidative Stress Changes in Different Ventilation Strategies During Gynecologic Laparoscopic Surgery
NCT ID: NCT02512640
Last Updated: 2015-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2013-05-31
2014-07-31
Brief Summary
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Methods:
Fifty-two patients of ASA physical status I or II were randomly assigned to receive either VCV or PCV during laparoscopic gynecologic surgery. Blood gas analysis and ventilation variables were recorded 1 minute before (T1) and 1 hour after (T2) pneumoperitoneum. Blood samples for malondialdehyde (MDA) measurement were collected at seven points: 1 minute before (T1) and 1 hour after (T2) pneumoperitoneum; 30 minutes, 60 minutes, 90 minutes, and 120 minutes after deflation (T3\~T6); and 24 hours after deflation (T7).
Detailed Description
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Although there is abundant data comparing the effects of VCV and PCV during laparoscopic surgery, the time course of changes in oxidative stress in these two modes has not been elucidated. Therefore, the aim of this study was to compare the alterations of oxidative stress in two different ventilation modes, VCV and PCV, during gynecologic laparoscopic surgery. To this end, the investigators established a prospective randomized clinical study and measured the plasma levels of a lipid peroxidation marker at different stages.
Fifty-two patients of ASA physical status I or II were randomly assigned to receive either VCV or PCV during laparoscopic gynecologic surgery. During the operation, blood gas analysis and ventilation variables were recorded 1 minute before (T1) and 1 hour after (T2) the establishment of CO2 pneumoperitoneum in both groups. Blood samples for MDA measurement were collected at seven points: 1 minute before (T1) and 1 hour after (T2) pneumoperitoneum; at intervals of 30 minutes for 2 hours after the deflation of CO2 (T3\~T6); and 24 hours after the deflation of CO2 (T7). The samples were immediately centrifuged (1000g, 10 minutes) and the supernatants were stored at -800C until further analysis, which took place within 1 week. The investigators assessed the quality of recovery from anesthesia using a nine-item quality of recovery score (QoR Score) before operation and 24 hours after the deflation of CO2.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Volume-controlled ventilation
Volume-controlled ventilation throughout the surgery
Volume-controlled ventilation
a tidal volume of 8 ml/kg
Pressure-controlled ventilation
Pressure-controlled ventilation throughout the surgery
Pressure-controlled ventilation
a peak airway pressure to maintain a tidal volume of 8 ml/kg
Interventions
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Volume-controlled ventilation
a tidal volume of 8 ml/kg
Pressure-controlled ventilation
a peak airway pressure to maintain a tidal volume of 8 ml/kg
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
70 Years
FEMALE
Yes
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Principal Investigators
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Chia-Chih Liao, MD
Role: PRINCIPAL_INVESTIGATOR
Chang Gung Memorial Hospital
Locations
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Department of Anesthesiology, Chang Gung Memorial Hospital
Taoyuan District, Taiwan, Taiwan
Countries
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References
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Sammour T, Mittal A, Loveday BP, Kahokehr A, Phillips AR, Windsor JA, Hill AG. Systematic review of oxidative stress associated with pneumoperitoneum. Br J Surg. 2009 Aug;96(8):836-50. doi: 10.1002/bjs.6651.
Del Rio D, Stewart AJ, Pellegrini N. A review of recent studies on malondialdehyde as toxic molecule and biological marker of oxidative stress. Nutr Metab Cardiovasc Dis. 2005 Aug;15(4):316-28. doi: 10.1016/j.numecd.2005.05.003.
Kontoulis TM, Pissas DG, Pavlidis TE, Pissas GG, Lalountas MA, Koliakos G, Topouridou K, Sakantamis AK. The oxidative effect of prolonged CO(2) pneumoperitoneum a comparative study in rats. J Surg Res. 2012 Jun 15;175(2):259-64. doi: 10.1016/j.jss.2011.09.030. Epub 2011 Oct 12.
Other Identifiers
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CGMH-IRB-102-0112A3
Identifier Type: -
Identifier Source: org_study_id