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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
History of Changes
  Purpose

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 Intervention
Oxidative Stress
 Drug: propofol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Official Title: Oxidative Stress in Robot-assisted Laparoscopic Radical Prostatectomy

Resource links provided by NLM:

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

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Amount of Malondialdehyde in plasma [ Time Frame: one day ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: December 2009
Estimated Study Completion Date: April 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01334424     History of Changes
Other Study ID Numbers: CGMH-IRB-98-2998B, CMRPG390841
Study First Received: February 27, 2011
Last Updated: April 12, 2011
Health Authority: Taiwan: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013