The Effect of Different Doses of Remifentanil on Kidney Function During Robot Assisted Prostatectomy - A Retrospective Study

Prostate Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02041559
• Other study ID #: 4-2013-0753
• Status: Recruiting
• Phase: N/A
• First received: January 13, 2014
• Last updated: January 17, 2014
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2014
• Source: Yonsei University
• Contact: Ji Eun Kim, MD
• Phone: 82-2-2019-6808
• Email: beye98[@]yuhs.ac
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial Summary

Robot assisted prostatectomy reduces the patients' postoperative pain and leads to rapid rehabilitation. But pneumoperitoneum affects the kidney. The increase of stress hormone reduces the glomerular filtration and the vaso-contraction of renal vessels leads the renal ischemia. Remifentanil is analgesics coupled with μ opioid receptor. In high dose of remifentanil, it is associated with κ and δ receptors, which leads to renal protection effect in animal study. Also, remifentanil infusion during anesthesia showed a diuretic effect. The purpose of this study is to investigate the remifentanil effect on renal function during robot assisted prostatectomy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• ages > 19 years and < 85 years

• the patients undergoing a general anesthesia for robot assisted prostatectomy

Exclusion Criteria:

• incomplete record

• history of opioid or steroid using

• solitary kidney

• history of kidney transplantation

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Prostate Cancer

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System	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	acute kidney injury incidence based on Acute Kidney Injury Network criteria	Acute kidney injury incidence based on Acute Kidney Injury Network criteria was defined as increase in serum creatinine from baseline of = 0.3 mg/dl within a 48-hour period. Acute kidney injury is evaluated at POD 1.	24 hours after end of surgery	No