Comparison of Dexmedetomidine and Remifentanil Infusion During CABG

NCT01572454 | Completed DMC

• 1 other identifier: 2012-02-012-001
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

We are trying to investigate whether intraoperative dexmedetomidine infusion could decrease the incidence of intraoperative hypokalemia and arrhythmia, and myocardial injury in patients undergoing off-pump coronary artery bypass graft, and trying compare these effects with those of remifentanil infusion.

Conditions

Coronary Artery Bypass Graft; Hypokalemia; Cardiac Arrhythmia; Dexmedetomidine; Remifentanil

Keywords

coronary artery bypass graft; hypokalemia; cardiac arrhythmia; dexmedetomidine; remifentanil

Outcome Measures

Primary Outcomes (5)

• serum potassium concentration

  serum potassium concentration at the day before anesthetic induction

  at 24 hour before anesthetic induction

• serum potassium concentration

  1 minutes before anesthetic induction (etomidate injection)

  1 minutes before anesthetic induction

• serum potassium concentration

  serum potassium concentration 20 minutes after start of anesthetic induction (at the end of anesthetic induction)

  20 minutes after start of anesthetic induction

• serum potassium concentration

  serum potassium concentration at 2 hour after anesthetic induction (after mammary artery dissection and graft formation)

  2 hour after the start of anesthetic induction

• serum potassium concentration

  serum potassium concentration at 3 hour after end of anesthetic induction (after the anastomosis of coronary graft)

  3 hour after start of anesthetic induction

Secondary Outcomes (6)

• arterial blood gas analysis results

  24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction

• incidence of hypokalemia

  24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction

• hemodynamic parameters

  24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction

• inotropics, vasopressor requirement

  24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction

• Myocardial injury marker

  2, 24, 48 hour after the end of surgery

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

Dexmedetomidine infusion 0.2 mcg/kg/hr during anesthetic induction 0.3 - 0.7 mcg/kg/hr during the surgery

Drug: Dexmedetomidine infusion

Remifentanil group

ACTIVE COMPARATOR

Remifentanil infusion 0.05 - 0.3 mcg/kg/min during the anesthetic induction and surgery

Drug: Remifentanil infusion

Interventions

Dexmedetomidine infusion DRUG

Dexmedetomidine infusion 0.2 mcg/kg/hr during anesthetic induction 0.3 - 0.7 mcg/kg/hr during the surgery

Also known as: Dexmedetomidine

Dexmedetomidine group

Remifentanil infusion DRUG

Remifentanil infusion 0.05 - 0.3 mcg/kg/min during the anesthetic induction and surgery

Also known as: Remifentanil

Remifentanil group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those undergoing off-pump coronary artery bypass graft during March, 2012 \~ February, 2013 in Samsung Medical Center
• Age between 20 and 70 yrs old

You may not qualify if:

• Any patients with plasma aldosterone, or glucocorticoid disorder including primary hyperaldosteronism, renovascular hypertension, rennin-secreting tumor, salt-wasting renal disease, Cushing syndrome
• Patients with recent exogenous steroid administration or previous diuretics therapy

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Hypokalemia; Arrhythmias, Cardiac

Interventions

Dexmedetomidine; Remifentanil

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines

Study Officials

• Hyun Sung Cho, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

• Won Ho Kim, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

• Young Tak Lee, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 4, 2012
• First Posted: April 6, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 25, 2013

Record last verified: 2013-12

Locations

KR (1)