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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02149628
• Other study ID #: 3-2013-0098
• Status: Completed
• Phase: Phase 4
• First received: May 19, 2014
• Last updated: July 27, 2015
• Start date: May 2014
• Est. completion date: February 2015

Study information

• Verified date: July 2015
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Drug:
• propofol

• Desflurane

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University, Gangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes of serum malondialdehyde, Interleukin-1ß, interleukin-6, tumor necrotic factor-a, nitric oxide during operation		100 min after pneumoperitoneum, 10 min after decompression	No
Secondary	kidney function after anesthesia	measure creatinine	1 day after operation	No