The Effect of Propofol Based Total Intravenous Anesthesia on Oxidative Stress and Nitric Oxide

NCT ID: NCT02149628

Last Updated: 2015-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-02-28

Brief Summary

Robot assisted laparoscopic radical prostatectomy(Robot-LRP) requires pneumoperitoneum and trendelenburg position which result in oxidative stress and inflammatory response.

Propofol is well known to reduce those responses during anesthesia. Therefore, we try to figure out the efficacy of propofol to reduce oxidative stress, inflammatory response and increase the nitric oxide activity during robot-LRP compared to that of desflurane.

To investigate the oxidative stress, malondialdehyde will be measured. As inflammatory markers, interleukin-1β, interleukin-6, tumor necrosis factor-α will be measured. Nitric oxide will be measured as well.

Secondarily, kidney protection effect of propofol over desflurane will be compared.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

desflurane

use desflurane as a primary anesthetics during anesthesia guided by bispectral index (BIS)

Group Type: ACTIVE_COMPARATOR

Desflurane

Intervention Type: DRUG

propofol

propofol infusion with target-controlled infusion(TCI) device guided by BIS

Group Type: EXPERIMENTAL

propofol

Intervention Type: DRUG

Interventions

propofol

Intervention Type: DRUG

Desflurane

Intervention Type: DRUG

Other Intervention Names

fresofol, 2%

Eligibility Criteria

Inclusion Criteria

• patients undergoing robot-assisted laparoscopic radical prostatectomy under general anesthesia

Exclusion Criteria

• chronic renal failure ( estimated glomerular filtration rate <60 mL/min/1.73m2)
• allergy to propofol, nuts
• on diuretics, vitamin C or vitamin E within 5 days before surgery
• Body mass index > 30 kg/m2
• older than 70 years
• who cannot read the patient consent form

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Goun Roh, MD

Role: PRINCIPAL_INVESTIGATOR

Yonsei University Gangnam Severance Hospital

Locations

Yonsei University, Gangnam Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

3-2013-0098

Identifier Type: -

Identifier Source: org_study_id