Oxidative Stress in Robot-assisted Laparoscopic Radical Prostatectomy
2 other identifiers
interventional
40
1 country
1
Brief Summary
Gut hypoperfusion - reperfusion injury is an unavoidable event at the end of laparoscopic surgery. It produces oxidative stress (reactive oxygen species). Malondialdehyde have been demonstrated to be a reliable biomarker for the evaluation of oxidative stress in vivo. Propofol (2, 6 - diisopropylphenol), a highly liposoluble anaesthetic, has a potent antioxidant activity against lipid peroxidation in both in vitron and in vivo studies. On the basis of this knowledge, the investigators hypothesized that propofol has preventive effect for gut hypoperfusion - reperfusion induced injury in robot-assisted laparoscopic radical prostatectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 27, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedFirst Posted
Study publicly available on registry
April 13, 2011
CompletedApril 13, 2011
April 1, 2011
1 year
February 27, 2011
April 12, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Amount of Malondialdehyde in plasma
one day
Study Arms (4)
no propofol
PLACEBO COMPARATORinduction anesthesia with midazolam 0.2 - 0.3 mg/kg
propofol induction
EXPERIMENTALinduction anesthesia with propofol 2 - 2.5 mg/kg
propofol maintenance
EXPERIMENTALinduction anesthesia with midazolam 0.2 - 0.3 mg/kg and maintain anesthesia with propofol 2 mg/kg.h (maintenance dose)
propofol induction and maintenance
EXPERIMENTALinduction anesthesia with propofol 2 - 2.5 mg/ kg and maintain anesthesia with propofol 2 mg/kg.h (maintenance dose)
Interventions
2-2.5 mg/kg for induction plus or not plus 2 mg/kg.h for maintenance
Eligibility Criteria
You may qualify if:
- patients receiving robot-assisted laparoscopic radical prostatectomy in ASA II-III physical status
You may not qualify if:
- history of sepsis or shock, clinically relevant cardiopulmonary disease, persistent tobacco abuse, recent antioxidant or vasoconstrictor use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept. of Anesthesiology, Chang Gung Memorial Hospital
Taoyuan District, 333, Taiwan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chiao-Fen Luo, MD
Dept. of Anesthesiology, Chang Gung Memorial Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 27, 2011
First Posted
April 13, 2011
Study Start
December 1, 2009
Primary Completion
December 1, 2010
Study Completion
April 1, 2011
Last Updated
April 13, 2011
Record last verified: 2011-04