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

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ClinicalTrials.gov Identifier: NCT02113150
Recruitment Status : Completed
First Posted : April 14, 2014
Last Update Posted : April 14, 2014
Sponsor:
Information provided by (Responsible Party):
aslı demir, Turkiye Yuksek Ihtisas Education and Research Hospital

Tracking Information
First Submitted Date  ICMJE March 23, 2014
First Posted Date  ICMJE April 14, 2014
Last Update Posted Date April 14, 2014
Study Start Date  ICMJE May 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2014)
creatinin, BUN [ Time Frame: 2 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2014)
Cystatin-c level [ Time Frame: 2 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 9, 2014)
GFR value [ Time Frame: 2 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Comparison of the Effects of Ketamine and Remifentanil on Serum Cystatin-c Levels in CABG Surgery
Official Title  ICMJE A Comparison of the Effects of Ketamine and Remifentanil on Serum Cystatin-c Levels in CABG Surgery
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Drug: remifentanil
    renal function
    Other Name: Ultiva
  • Drug: Ketamine
    renal function
    Other Name: ketalar
Study Arms  ICMJE
  • Active Comparator: remifentanil
    remifentanil, short acting opioid
    Intervention: Drug: Ketamine
  • Active Comparator: ketamine
    ketamine, intravenous anesthetic
    Intervention: Drug: remifentanil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2014)
37
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02113150
Other Study ID Numbers  ICMJE TurkiyeYIH
Zaslidem ( Registry Identifier: aslı demir )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party aslı demir, Turkiye Yuksek Ihtisas Education and Research Hospital
Study Sponsor  ICMJE Turkiye Yuksek Ihtisas Education and Research Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aslı Demir Turkey Yuksek Ihtisas Education and Research Hospital
PRS Account Turkiye Yuksek Ihtisas Education and Research Hospital
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP