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

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

propofol

Desflurane

About this trial

This is an interventional prevention trial for Prostate Cancer

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Yonsei University, Gangnam Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

desflurane

propofol

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

kidney function after anesthesia

measure creatinine

Full Information

NCT ID

NCT02149628

First Posted

May 19, 2014

Last Updated

July 27, 2015

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02149628

Brief Title

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

Official Title

The Effect of Propofol Based Total Intravenous Anesthesia on Oxidative Stress and Nitric Oxide in Patients Undergoing Laparoscopic Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

May 2014 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

desflurane

Arm Type

Active Comparator

Arm Description

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

Arm Title

propofol

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

propofol

Other Intervention Name(s)

fresofol, 2%

Intervention Type

Drug

Intervention Name(s)

Desflurane

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

kidney function after anesthesia

Description

measure creatinine

Time Frame

1 day after operation

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Goun Roh, MD

Organizational Affiliation

Yonsei University Gangnam Severance Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yonsei University, Gangnam Severance Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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