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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02149628
Recruitment Status : Completed
First Posted : May 29, 2014
Last Update Posted : July 29, 2015
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: propofol Drug: Desflurane Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Propofol Based Total Intravenous Anesthesia on Oxidative Stress and Nitric Oxide in Patients Undergoing Laparoscopic Surgery
Study Start Date : May 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: desflurane
use desflurane as a primary anesthetics during anesthesia guided by bispectral index (BIS)
Drug: Desflurane
Experimental: propofol
propofol infusion with target-controlled infusion(TCI) device guided by BIS
Drug: propofol
Other Name: fresofol, 2%

Primary Outcome Measures :
  1. changes of serum malondialdehyde, Interleukin-1β, interleukin-6, tumor necrotic factor-α, nitric oxide during operation [ Time Frame: 100 min after pneumoperitoneum, 10 min after decompression ]

Secondary Outcome Measures :
  1. kidney function after anesthesia [ Time Frame: 1 day after operation ]
    measure creatinine

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02149628

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Korea, Republic of
Yonsei University, Gangnam Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
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Principal Investigator: Goun Roh, MD Yonsei University Gangnam Severance Hospital
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Responsible Party: Yonsei University Identifier: NCT02149628    
Other Study ID Numbers: 3-2013-0098
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Inhalation