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.

Study Overview

• Status: Unknown
• Conditions: Oxidative Stress
• Intervention / Treatment: Drug: propofol

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

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

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

How is the study designed?

Design Details

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

Number of Arms

4

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	one day

Collaborators and Investigators

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

Study record dates

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: Propofol; oxidative stress; Robot assisted laparoscopic radical prostatectomy; Hypoperfusion reperfusion injury,
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: CGMH-IRB-98-2998B; CMRPG390841 (Other Grant/Funding Number: Chang Gung Memorial Hospital)