Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery

Phase 4

Completed

• Conditions: Heart Disease
• Interventions: Drug: Dexmedetomidine; Drug: Placebo

• Registration Number: NCT02004613
• Lead Sponsor: The Cleveland Clinic

Brief Summary

Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery

Detailed Description

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

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-08-01
• Study First Submitted QC: 2013-12-04
• Study First Posted: 2013-12-09
• Primary Completion: 2018-12
• Study Completion: 2020-12-18
• Results First Submitted: 2020-12-18
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-12
• Last Update Submitted: 2021-03-12
• Results First Posted: 2021-04-06
• Last Update Posted: 2021-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 798

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine	Dexmedetomidine	Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively.
Placebo	Placebo	normal saline administration matching dexmedetomidine rate of infusion.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Delirium	From the end of surgery to postoperative day 5	The occurrence of postoperative delirium
Number of Patients With Atrial Arrhythmia	From the end of surgery to postoperative day 5	The occurrence of postoperative atrial arrhythmias

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Acute Kidney Injury	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.
Number of Patients With Incisional Pain	90 days after surgery	Patients were evaluated at 90 days by modified Brief Pain Inventory.

Trial Locations

Locations (1)

Cleveland Clinic Main; 🇺🇸 Cleveland, Ohio, United States