Phase 4 N=798 Randomized Double-blind Treatment

Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery

Heart Disease

Bottom Line

View on ClinicalTrials.gov: NCT02004613 ↗

Enrolled (actual)

798

Serious AEs

3.7%

Results posted

Apr 2021

Primary outcome: Primary: Number of Patients With Atrial Arrhythmia — 121; 134 Participants — p=0.34

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Dexmedetomidine (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Cleveland Clinic
Primary completion: Dec 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With Atrial Arrhythmia	121; 134	0.34
PRIMARY Number of Patients With Delirium	67; 46	0.026 sig
SECONDARY Number of Patients With Acute Kidney Injury	348; 359; 33; 29; 4; 0	0.14
SECONDARY Number of Patients With Incisional Pain	79; 93	0.29

Summary

Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02004613). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.