Back to resultsA Comparison of the Effects of Ketamine and Remifentanil on Serum Cystatin-c Levels in CABG Surgery
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
remifentanil
Ketamine
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease focused on measuring troponin t,cystatin-c,ketamine,remifentanil
Eligibility Criteria
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.
Sites / Locations
- Aslı Demir
- Turkey Yuksek Ihtisas Education and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
remifentanil
ketamine
Arm Description
remifentanil, short acting opioid
ketamine, intravenous anesthetic
Outcomes
Primary Outcome Measures
creatinin, BUN
Secondary Outcome Measures
Cystatin-c level
Full Information
NCT ID
NCT02113150
First Posted
March 23, 2014
Last Updated
April 9, 2014
Sponsor
Turkiye Yuksek Ihtisas Education and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02113150
Brief Title
A Comparison of the Effects of Ketamine and Remifentanil on Serum Cystatin-c Levels in CABG Surgery
Official Title
A Comparison of the Effects of Ketamine and Remifentanil on Serum Cystatin-c Levels in CABG Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turkiye Yuksek Ihtisas Education and Research Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
troponin t,cystatin-c,ketamine,remifentanil
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
remifentanil
Arm Type
Active Comparator
Arm Description
remifentanil, short acting opioid
Arm Title
ketamine
Arm Type
Active Comparator
Arm Description
ketamine, intravenous anesthetic
Intervention Type
Drug
Intervention Name(s)
remifentanil
Other Intervention Name(s)
Ultiva
Intervention Description
renal function
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
ketalar
Intervention Description
renal function
Primary Outcome Measure Information:
Title
creatinin, BUN
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Cystatin-c level
Time Frame
2 months
Other Pre-specified Outcome Measures:
Title
GFR value
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aslı Demir
Organizational Affiliation
Turkey Yuksek Ihtisas Education and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aslı Demir
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Turkey Yuksek Ihtisas Education and Research Hospital
City
Ankara
ZIP/Postal Code
06550
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
A Comparison of the Effects of Ketamine and Remifentanil on Serum Cystatin-c Levels in CABG Surgery
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