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

NCT02149628 | Completed Phase 4 DMC

• 1 other identifier: 3-2013-0098
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• changes of serum malondialdehyde, Interleukin-1β, interleukin-6, tumor necrotic factor-α, nitric oxide during operation

  100 min after pneumoperitoneum, 10 min after decompression

Secondary Outcomes (1)

• kidney function after anesthesia

  1 day after operation

Study Arms (2)

desflurane

ACTIVE COMPARATOR

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

Drug: Desflurane

propofol

EXPERIMENTAL

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

Drug: propofol

Interventions

propofol DRUG

Also known as: fresofol, 2%

propofol

Desflurane DRUG

desflurane

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University, Gangnam Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Propofol; Desflurane

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ethyl Ethers; Ethers; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Goun Roh, MD

  Yonsei University Gangnam Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 29, 2014
• Study Start: May 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: July 29, 2015

Record last verified: 2015-07

Locations

KR (1)