Oxidative Stress in Robot-assisted Laparoscopic Radical Prostatectomy

Chang Gung Medical Foundation

Status: Unknown

Conditions: Oxidative Stress

Treatments: Drug: propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT01334424

CMRPG390841 (Other Grant/Funding Number)

CGMH-IRB-98-2998B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 4 patient groups, including a placebo group

no propofol

Placebo Comparator group

Description:

induction anesthesia with midazolam 0.2 - 0.3 mg/kg

Treatment:

Drug: propofol

propofol induction

Experimental group

Description:

induction anesthesia with propofol 2 - 2.5 mg/kg

Treatment:

Drug: propofol

propofol maintenance

Experimental group

Description:

induction anesthesia with midazolam 0.2 - 0.3 mg/kg and maintain anesthesia with propofol 2 mg/kg.h (maintenance dose)

Treatment:

Drug: propofol

propofol induction and maintenance

Experimental group

Description:

induction anesthesia with propofol 2 - 2.5 mg/ kg and maintain anesthesia with propofol 2 mg/kg.h (maintenance dose)

Treatment:

Drug: propofol