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

NCT02113150 | Completed Phase 4 DMC

• 2 other identifiers: TurkiyeYIHZaslidem
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Artery Disease

Keywords

troponin t,cystatin-c,ketamine,remifentanil

Outcome Measures

Primary Outcomes (1)

• creatinin, BUN

  2 months

Secondary Outcomes (1)

• Cystatin-c level

  2 months

Other Outcomes (1)

• GFR value

  2 months

Study Arms (2)

remifentanil

ACTIVE COMPARATOR

remifentanil, short acting opioid

Drug: Ketamine

ketamine

ACTIVE COMPARATOR

ketamine, intravenous anesthetic

Drug: remifentanil

Interventions

remifentanil DRUG

renal function

Also known as: Ultiva

ketamine

Ketamine DRUG

renal function

Also known as: ketalar

remifentanil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing elective CABG with cardiopulmonary bypass

You may not qualify if:

• 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.

Sponsors & Collaborators

• Turkiye Yuksek Ihtisas Education and Research Hospital: lead

Study Sites (2)

Aslı Demir

Ankara, Ankara, 06100, Turkey (Türkiye)

Location

Turkey Yuksek Ihtisas Education and Research Hospital

Ankara, 06550, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Remifentanil; Ketamine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Aslı Demir

  Turkey Yuksek Ihtisas Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Z.Aslı Demir, MD, Assoc.Prof

Study Record Dates

• First Submitted: March 23, 2014
• First Posted: April 14, 2014
• Study Start: May 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: September 1, 2013
• Last Updated: April 14, 2014

Record last verified: 2014-04

Locations

TU (2)