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

NCT ID: NCT02113150

Last Updated: 2014-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-09-30

Brief Summary

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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

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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remifentanil

remifentanil, short acting opioid

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

renal function

ketamine

ketamine, intravenous anesthetic

Group Type ACTIVE_COMPARATOR

remifentanil

Intervention Type DRUG

renal function

Interventions

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remifentanil

renal function

Intervention Type DRUG

Ketamine

renal function

Intervention Type DRUG

Other Intervention Names

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Ultiva ketalar

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Turkiye Yuksek Ihtisas Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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aslı demir

Z.Aslı Demir, MD, Assoc.Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aslı Demir

Role: PRINCIPAL_INVESTIGATOR

Turkey Yuksek Ihtisas Education and Research Hospital

Locations

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Aslı Demir

Ankara, Ankara, Turkey (Türkiye)

Site Status

Turkey Yuksek Ihtisas Education and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Zaslidem

Identifier Type: REGISTRY

Identifier Source: secondary_id

TurkiyeYIH

Identifier Type: -

Identifier Source: org_study_id

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