Oxidative Stress in Robot-assisted Laparoscopic Radical Prostatectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Chang Gung Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01334424
First received: February 27, 2011
Last updated: April 12, 2011
Last verified: April 2011

February 27, 2011
April 12, 2011
December 2009
December 2010   (final data collection date for primary outcome measure)
Amount of Malondialdehyde in plasma [ Time Frame: one day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01334424 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Oxidative Stress in Robot-assisted Laparoscopic Radical Prostatectomy
Oxidative Stress in Robot-assisted Laparoscopic Radical Prostatectomy

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Oxidative Stress
Drug: propofol
2-2.5 mg/kg for induction plus or not plus 2 mg/kg.h for maintenance
  • Placebo Comparator: no propofol
    induction anesthesia with midazolam 0.2 - 0.3 mg/kg
    Intervention: Drug: propofol
  • Experimental: propofol induction
    induction anesthesia with propofol 2 - 2.5 mg/kg
    Intervention: Drug: propofol
  • Experimental: propofol maintenance
    induction anesthesia with midazolam 0.2 - 0.3 mg/kg and maintain anesthesia with propofol 2 mg/kg.h (maintenance dose)
    Intervention: Drug: propofol
  • 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)
    Intervention: Drug: propofol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
April 2011
December 2010   (final data collection date for primary outcome measure)

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
Male
20 Years to 80 Years
No
Taiwan
 
NCT01334424
CGMH-IRB-98-2998B, CMRPG390841
No
Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
Not Provided
Principal Investigator: Chiao-Fen Luo, MD Dept. of Anesthesiology, Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP