Oxidative Stress in Robot-assisted Laparoscopic Radical Prostatectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Oxidative Stress in Robot-assisted Laparoscopic Radical Prostatectomy

Conditions
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Oxidative Stress

Intervention / Treatment
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* Drug: propofol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: no propofol<br>induction anesthesia with midazolam 0.2 - 0.3 mg/kg | Drug: propofol<br>* 2-2.5 mg/kg for induction plus or not plus 2 mg/kg.h for maintenance<br>|
| Experimental: propofol induction<br>induction anesthesia with propofol 2 - 2.5 mg/kg | Drug: propofol<br>* 2-2.5 mg/kg for induction plus or not plus 2 mg/kg.h for maintenance<br>|
| Experimental: propofol maintenance<br>induction anesthesia with midazolam 0.2 - 0.3 mg/kg and maintain anesthesia with propofol 2 mg/kg.h (maintenance dose) | Drug: propofol<br>* 2-2.5 mg/kg for induction plus or not plus 2 mg/kg.h for maintenance<br>|
| Experimental: propofol induction and maintenance<br>induction anesthesia with propofol 2 - 2.5 mg/ kg and maintain anesthesia with propofol 2 mg/kg.h (maintenance dose) | Drug: propofol<br>* 2-2.5 mg/kg for induction plus or not plus 2 mg/kg.h for maintenance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Malondialdehyde in plasma |  | one day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robot assisted laparoscopic radical prostatectomy, Hypoperfusion reperfusion injury,, Propofol, oxidative stress