Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery

Heart Disease Clinical Trial

— Decade  

Official title:

Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02004613
• Other study ID #: 12-1379
• Status: Completed
• Phase: Phase 4
• Start date: June 2013
• Est. completion date: December 18, 2020

Study information

• Verified date: March 2021
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 798
• Est. completion date: December 18, 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. 18-85 years old;

2. Scheduled for cardiac surgery with bypass (CABG, valve, or combined);

3. Able to provide a written informed consent;

4. Hemodynamically stable (heart rate>= 55).

Exclusion Criteria:

1. Sick sinus syndrome or Wolff-Parkinson-White syndrome

2. Atrio-ventricular block

3. Hypersensitivity or known allergy to dexmedetomidine

4. Hepatic disease, e.g. twice the normal level of liver enzymes

5. Atrial fibrillation within 1 preoperative month;

6. Permanent pacemaker;

7. Use of amiodarone or dexmedetomidine within the last 30 days;

8. Patients with an ejection fraction under 30% or who had severe heart failure

9. Myocardial infarction in the previ¬ous 7 days;

10. Body mass index =< 40 (BMI= mass (kg) / height (m)2);

11. Those taking clonidine within last 48 hours.

Related Conditions & MeSH terms

• Heart Disease
• Heart Diseases

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine
• Placebo
Normal saline administration matching dexmedetomidine rate of infusion

Locations

Country	Name	City	State
United States	Cleveland Clinic Main	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Hospira, now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Atrial Arrhythmia	The occurrence of postoperative atrial arrhythmias	From the end of surgery to postoperative day 5
Primary	Number of Patients With Delirium	The occurrence of postoperative delirium	From the end of surgery to postoperative day 5
Secondary	Number of Patients With Acute Kidney Injury	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.	From the end of surgery to postoperative day 5
Secondary	Number of Patients With Incisional Pain	Patients were evaluated at 90 days by modified Brief Pain Inventory.	90 days after surgery