search
Back to results

Comparison of Oxidative Stress Changes in Different Ventilation Strategies During Gynecologic Laparoscopic Surgery

Primary Purpose

Reperfusion Injury, Oxidative Stress

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Volume-controlled ventilation
Pressure-controlled ventilation
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Reperfusion Injury focused on measuring Pressure-controlled ventilation, Volume-controlled ventilation, Laparoscopy, Oxidative stress

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

  • Department of Anesthesiology, Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Volume-controlled ventilation

Pressure-controlled ventilation

Arm Description

Volume-controlled ventilation throughout the surgery

Pressure-controlled ventilation throughout the surgery

Outcomes

Primary Outcome Measures

peak airway pressure
During surgery, CO2 pneumoperitoneum was induced with an intraabdominal pressure of 15 mmHg. After one hour of pneumoperitoneum, ventilation variables were recorded.

Secondary Outcome Measures

plasma MDA concentration

Full Information

First Posted
July 6, 2015
Last Updated
July 30, 2015
Sponsor
Chang Gung Memorial Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02512640
Brief Title
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

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reperfusion Injury, Oxidative Stress
Keywords
Pressure-controlled ventilation, Volume-controlled ventilation, Laparoscopy, Oxidative stress

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Volume-controlled ventilation
Arm Type
Active Comparator
Arm Description
Volume-controlled ventilation throughout the surgery
Arm Title
Pressure-controlled ventilation
Arm Type
Active Comparator
Arm Description
Pressure-controlled ventilation throughout the surgery
Intervention Type
Procedure
Intervention Name(s)
Volume-controlled ventilation
Intervention Description
a tidal volume of 8 ml/kg
Intervention Type
Procedure
Intervention Name(s)
Pressure-controlled ventilation
Intervention Description
a peak airway pressure to maintain a tidal volume of 8 ml/kg
Primary Outcome Measure Information:
Title
peak airway pressure
Description
During surgery, CO2 pneumoperitoneum was induced with an intraabdominal pressure of 15 mmHg. After one hour of pneumoperitoneum, ventilation variables were recorded.
Time Frame
1 hour after the establishment of CO2 pneumoperitoneum
Secondary Outcome Measure Information:
Title
plasma MDA concentration
Time Frame
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-Chih Liao, MD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology, Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
19591166
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.
Results Reference
background
PubMed Identifier
16054557
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.
Results Reference
background
PubMed Identifier
22172128
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.
Results Reference
background

Learn more about this trial

Comparison of Oxidative Stress Changes in Different Ventilation Strategies During Gynecologic Laparoscopic Surgery

We'll reach out to this number within 24 hrs