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NCT02113150 Clinical Trial

A Comparison of the Effects of Ketamine and Remifentanil on Serum Cystatin-c Levels in CABG Surgery

Coronary Artery Disease Clinical Trial

Official title:
A Comparison of the Effects of Ketamine and Remifentanil on Serum Cystatin-c Levels in CABG Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02113150
Other study ID # TurkiyeYIH
Secondary ID Zaslidem
Status Completed
Phase Phase 4
First received March 23, 2014
Last updated April 9, 2014
Start date May 2013
Est. completion date September 2013

Study information
Verified date April 2014
Source Turkiye Yuksek Ihtisas Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Interventional

Clinical Trial Summary

In this prospective, randomized, clinical trial, we have investigated the effects of ketamine-based and remifentanil-based anesthetic protocol on perioperative serum cystatin-c levels, and creatinine and/or cystatin-c based eGFR equations in terms of acute kidney injury in CABG surgery.This study was approved by the Ethics Committee of Hospital and all patients were informed and gave written consent. Patients scheduled for elective CABG with cardiopulmonary bypass. Patients were randomly allocated to anesthesia with remifentanil-propofol-midazolam (RPM) group or ketamine-propofol-midazolam (KPM) group. Blood samples were obtained before induction of anesthesia (baseline), at the end of the operation, and postoperative days 1, 2, and 4.

Recruitment information / eligibility
Status Completed
Enrollment 37
Est. completion date September 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

patients undergoing elective CABG with cardiopulmonary bypass

Exclusion Criteria:

patients undergoing emergency operation, combined operation, off-pump surgery, repeat surgery or valve surgery, patients presenting with chronic kidney disease or renal impairment, patients younger than 18 years old and neurological and/or psychiatric disturbances.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• remifentanil
renal function
• Ketamine
renal function

Locations
Country Name City State
Turkey Asli Demir Ankara
Turkey Turkey Yuksek Ihtisas Education and Research Hospital Ankara

Sponsors (1)
Lead Sponsor Collaborator
Turkiye Yuksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Other GFR value 2 months Yes
Primary creatinin, BUN 2 months Yes
Secondary Cystatin-c level 2 months Yes
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