Clinical trial NCT02512640: Comparison of Oxidative Stress Changes in Different Ventilation Strategies During Gynecologic Laparoscopic Surgery
Official title: Comparison of Oxidative Stress Changes in Different Ventilation Strategies During Gynecologic Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reperfusion Injury
Oxidative Stress
Keywords: Pressure-controlled ventilation
Volume-controlled ventilation
Laparoscopy
Oxidative stress
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2015-07-31
Enrollment: 52
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Ischemia-reperfusion injury resulted from pneumoperitoneum during laparoscopic surgery have been reported in some literatures. There are no studies investigating the time course of changes in oxidative stress markers in volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV) modes. The aim of this study is to compare the alterations in oxidative stress in two different ventilation strategies during gynecologic laparoscopic surgery.

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: Pneumoperitoneum during laparoscopic procedures greatly impairs splanchnic blood flow due to compression. Increased intra-abdominal pressure may elevate the diaphragm, increase intra-thoracic pressure, reduce functional residual capacity, and thus lead to atelectasis. In a collapsed lung, blood flow is decreased and reperfusion injury may subsequently occur during re-expansion of the lung. This ischemia-reperfusion injury results from the formation of reactive oxygen species (ROS), which are highly reactive intermediates of the oxygen metabolism. When there is an imbalance between ROS generation and removal by antioxidative mechanisms, oxidative stress occurs and eventually causes cellular and organ damage. Oxidative stress mediates tissue injury and may represent an important link between laparoscopy and clinical side effects. Malondialdehyde (MDA) is considered the most reliable marker of oxidative stress in the clinical setting. It is a breakdown product of lipid peroxidation in tissues. An elevated concentration of MDA reflects the level of lipid peroxidation.

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.

Eligibility criteria: Inclusion Criteria:

* aged between 20 and 70 years with a BMI \< 30 kg/m2 scheduled for laparoscopic gynecologic surgery requiring at least 1 hour of pneumoperitoneum

Exclusion Criteria:

* cardiopulmonary disease and a history of sepsis or shock, findings suspicious of malignant disease, previous major abdominal operation, smoking, and recent antioxidant use (i.e. vitamins A, C and E).

Primary outcomes:
measure: peak airway pressure
timeFrame: 1 hour after the establishment of CO2 pneumoperitoneum
Secondary outcomes:
measure: plasma MDA concentration
timeFrame: 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)
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Department of Anesthesiology, Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chia-Chih Liao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.