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Completed

NCT Number: NCT02004613

Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery

Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery

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Key information

Conditions

Heart Disease Cardiovascular Diseases Heart Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cleveland Clinic Main

Cleveland, Ohio, 44195, United States

About this study

The investigator goal is to evaluate the effects of intraoperative and postoperative dexmedetomidine sedation (versus placebo after cardiac surgery.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-85 years old;
  • Scheduled for cardiac surgery with bypass (CABG, valve, or combined);
  • Able to provide a written informed consent;
  • Hemodynamically stable (heart rate>= 55).

Exclusion criteria

  • Sick sinus syndrome or Wolff-Parkinson-White syndrome
  • Atrio-ventricular block
  • Hypersensitivity or known allergy to dexmedetomidine
  • Hepatic disease, e.g. twice the normal level of liver enzymes
  • Atrial fibrillation within 1 preoperative month;
  • Permanent pacemaker;
  • Use of amiodarone or dexmedetomidine within the last 30 days;
  • Patients with an ejection fraction under 30% or who had severe heart failure
  • Myocardial infarction in the previ¬ous 7 days;
  • Body mass index =< 40 (BMI= mass (kg) / height (m)2);
  • Those taking clonidine within last 48 hours.

Treatment and study plan

Dexmedetomidine

Drug

Dexmedetomidine

Placebo

Drug

Normal saline administration matching dexmedetomidine rate of infusion

Other names: Saline

Primary outcomes

  1. Number of Patients With Atrial Arrhythmia

    Time frame: From the end of surgery to postoperative day 5

    The occurrence of postoperative atrial arrhythmias

  2. Number of Patients With Delirium

    Time frame: From the end of surgery to postoperative day 5

    The occurrence of postoperative delirium

Secondary outcomes

  1. Number of Patients With Acute Kidney Injury

    Time frame: From the end of surgery to postoperative day 5

    Acute kidney injury is defined according to Acute Kidney Injury Network (AKIN) classifications. No risk means no risk of acute kidney injury, while a higher stage means worse kidney function.

  2. Number of Patients With Incisional Pain

    Time frame: 90 days after surgery

    Patients were evaluated at 90 days by modified Brief Pain Inventory.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Hospira, now a wholly owned subsidiary of Pfizer

Registry information

Acronym: Decade

Important dates

Study start
2013
Primary completion
2018
Study completion
2020
First posted
Dec 9, 2013
Registry last updated
Apr 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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