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Oxidative Stress in Robot-assisted Laparoscopic Radical Prostatectomy

Oxidative Stress in Robot-assisted Laparoscopic Radical Prostatectomy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01334424
Enrollment
40
Registered
2011-04-13
Start date
2009-12-31
Completion date
2011-04-30
Last updated
2011-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxidative Stress

Keywords

Robot assisted laparoscopic radical prostatectomy, Hypoperfusion reperfusion injury,, Propofol, oxidative stress

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.

Detailed description

Increased intrabdominal pressure is associated with pneumoperitoneum for laparoscopic procedures and is one of the main factors in impairment of splanchnic perfusion by compressing vessels. An hypoperfusion - reperfusion human model is observed during and soon after laparoscopic surgery. After deflation of the abdomen, intrabdominal pressure and splanchnic blood flow normalize, representing reperfusion. Reactive oxygen species is produced in metabolic and physiologic processes, and harmful oxidative reactions may occur in organisms that remove them via enzymatic and nonenzymatic antioxidative mechanisms. Propofol (2, 6 - diisopropylphenol), a highly liposoluble anaesthetic, has a potent antioxidant activity against lipid peroxidation in both in vitron and in vivo studies. Propofol also attenuates ischemia - reperfusion induced lipid peroxidation in humans. On the basis of this knowledge, we hypothesized that propofol has preventive effect for gut hypoperfusion - reperfusion induced injury in robot-assisted laparoscopic radical prostatectomy.

Interventions

DRUGpropofol

2-2.5 mg/kg for induction plus or not plus 2 mg/kg.h for maintenance

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* patients receiving robot-assisted laparoscopic radical prostatectomy in ASA II-III physical status

Exclusion criteria

* history of sepsis or shock, clinically relevant cardiopulmonary disease, persistent tobacco abuse, recent antioxidant or vasoconstrictor use

Design outcomes

Primary

MeasureTime frame
Amount of Malondialdehyde in plasmaone day

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026