A Comparison of the Effects of Ketamine and Remifentanil... | NCT02113150

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

NCT02113150

Sponsor

Turkiye Yuksek Ihtisas Education and Research Hospital

Status

Completed

Last Update Posted

Apr 14, 2014Estimated

Enrollment

37Actual

Phase

Phase 4

Conditions

Coronary Artery Disease

Interventions

remifentanil
Ketamine

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Zaslidem	Registry Identifier	aslı demir

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Jul 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Mar 23, 2014

First Submission Date that Met QC Criteria

Apr 9, 2014

First Posted Date

Apr 14, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2014

Last Update Posted Date

Apr 14, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

aslı demir, Z.Aslı Demir, MD, Assoc.Prof, Turkiye Yuksek Ihtisas Education and Research HospitalPrincipal Investigator

Lead Sponsor

Turkiye Yuksek Ihtisas Education and Research HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
remifentanil	Active Comparator	remifentanil, short acting opioid	Drug: Ketamine
ketamine	Active Comparator	ketamine, intravenous anesthetic	Drug: remifentanil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
remifentanil	Drug	renal function	ketamine	Ultiva

Measure	Description	Time Frame
creatinin, BUN		2 months

Measure	Description	Time Frame
Cystatin-c level		2 months

Measure	Description	Time Frame
GFR value		2 months

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aslı Demir	Turkey Yuksek Ihtisas Education and Research Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aslı Demir		Ankara	Ankara	06100	Turkey (Türkiye)
Turkey Yuksek Ihtisas Education and Research Hospital

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077208	Remifentanil
D007649	Ketamine

Ancestor Terms

ID	Term
D011422	Propionates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided