NCT02512640

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 6, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 31, 2015

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

3 months

First QC Date

July 6, 2015

Last Update Submit

July 30, 2015

Conditions

Reperfusion InjuryOxidative Stress

Keywords

Pressure-controlled ventilationVolume-controlled ventilationLaparoscopyOxidative stress

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 hour after the establishment of CO2 pneumoperitoneum

Secondary Outcomes (1)

  • plasma MDA concentration

    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)

Study Arms (2)

Volume-controlled ventilation

ACTIVE COMPARATOR

Volume-controlled ventilation throughout the surgery

Procedure: Volume-controlled ventilation

Pressure-controlled ventilation

ACTIVE COMPARATOR

Pressure-controlled ventilation throughout the surgery

Procedure: Pressure-controlled ventilation

Interventions

Volume-controlled ventilationPROCEDURE

a tidal volume of 8 ml/kg

Volume-controlled ventilation
Pressure-controlled ventilationPROCEDURE

a peak airway pressure to maintain a tidal volume of 8 ml/kg

Pressure-controlled ventilation

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Chang Gung Memorial Hospital

Taoyuan District, Taiwan, 333, Taiwan

Location

Related Publications (3)

  • 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.

    PMID: 19591166BACKGROUND

  • 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.

    PMID: 16054557BACKGROUND

  • 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.

    PMID: 22172128BACKGROUND

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chia-Chih Liao, MD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2015

First Posted

July 31, 2015

Study Start

May 1, 2013

Primary Completion

August 1, 2013

Study Completion

July 1, 2014

Last Updated

July 31, 2015

Record last verified: 2015-07

Locations

TW(1)