Oxidative Stress in Robot-assisted Laparoscopic Radical Prostatectomy

April 12, 2011 updated by: Chang Gung Memorial Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tao-Yuan, Taiwan, 333
        • Recruiting
        • Dept. of Anesthesiology, Chang Gung Memorial Hospital
        • Contact:
          • Chiao-Fen Luo, MD
          • Phone Number: 2324 011-886-3-3281200
        • Principal Investigator:
          • Chiao-Fen Luo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Amount of Malondialdehyde in plasma
Time Frame: one day
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Chiao-Fen Luo, MD, Dept. of Anesthesiology, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Anticipated)

April 1, 2011

Study Registration Dates

First Submitted

February 27, 2011

First Submitted That Met QC Criteria

April 12, 2011

First Posted (Estimate)

April 13, 2011

Study Record Updates

Last Update Posted (Estimate)

April 13, 2011

Last Update Submitted That Met QC Criteria

April 12, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGMH-IRB-98-2998B
  • CMRPG390841 (Other Grant/Funding Number: Chang Gung Memorial Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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