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Oxidative Stress in Robot-assisted Laparoscopic Radical Prostatectomy

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ClinicalTrials.gov Identifier: NCT01334424
Recruitment Status : Unknown
Verified April 2011 by Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : April 13, 2011
Last Update Posted : April 13, 2011
Sponsor:
Information provided by:
Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Oxidative Stress Drug: propofol Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Official Title: Oxidative Stress in Robot-assisted Laparoscopic Radical Prostatectomy
Study Start Date : December 2009
Actual Primary Completion Date : December 2010
Estimated Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: no propofol
induction anesthesia with midazolam 0.2 - 0.3 mg/kg
Drug: propofol
2-2.5 mg/kg for induction plus or not plus 2 mg/kg.h for maintenance
Experimental: propofol induction
induction anesthesia with propofol 2 - 2.5 mg/kg
Drug: propofol
2-2.5 mg/kg for induction plus or not plus 2 mg/kg.h for maintenance
Experimental: propofol maintenance
induction anesthesia with midazolam 0.2 - 0.3 mg/kg and maintain anesthesia with propofol 2 mg/kg.h (maintenance dose)
Drug: propofol
2-2.5 mg/kg for induction plus or not plus 2 mg/kg.h for maintenance
Experimental: propofol induction and maintenance
induction anesthesia with propofol 2 - 2.5 mg/ kg and maintain anesthesia with propofol 2 mg/kg.h (maintenance dose)
Drug: propofol
2-2.5 mg/kg for induction plus or not plus 2 mg/kg.h for maintenance



Primary Outcome Measures :
  1. Amount of Malondialdehyde in plasma [ Time Frame: one day ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01334424


Locations
Taiwan
Dept. of Anesthesiology, Chang Gung Memorial Hospital Recruiting
Tao-Yuan, Taiwan, 333
Contact: Chiao-Fen Luo, MD    011-886-3-3281200 ext 2324      
Principal Investigator: Chiao-Fen Luo, MD         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Chiao-Fen Luo, MD Dept. of Anesthesiology, Chang Gung Memorial Hospital

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01334424     History of Changes
Other Study ID Numbers: CGMH-IRB-98-2998B
CMRPG390841 ( Other Grant/Funding Number: Chang Gung Memorial Hospital )
First Posted: April 13, 2011    Key Record Dates
Last Update Posted: April 13, 2011
Last Verified: April 2011

Keywords provided by Chang Gung Memorial Hospital:
Robot assisted laparoscopic radical prostatectomy
Hypoperfusion reperfusion injury,
Propofol
oxidative stress

Additional relevant MeSH terms:
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics