Heart Disease
Conditions
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.
Interventions
DRUGDexmedetomidine
Dexmedetomidine
DRUGPlacebo
Normal saline administration matching dexmedetomidine rate of infusion
Sponsors
Hospira, now a wholly owned subsidiary of Pfizer
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Atrial Arrhythmia | From the end of surgery to postoperative day 5 | The occurrence of postoperative atrial arrhythmias |
| Number of Patients With Delirium | From the end of surgery to postoperative day 5 | The occurrence of postoperative delirium |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Dexmedetomidine: Dexmedetomidine | 398 |
| Placebo normal saline administration matching dexmedetomidine rate of infusion.
Placebo: Normal saline administration matching dexmedetomidine rate of infusion | 396 |
| Total | 794 |
Baseline characteristics
| Characteristic | Placebo | Total | Dexmedetomidine |
|---|---|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 12 | 63 years STANDARD_DEVIATION 12 | 63 years STANDARD_DEVIATION 11 |
| Modified Brief Pain Inventory Overall Severity (any) | 89 Participants | 184 Participants | 95 Participants |
| Modified Brief Pain Inventory Pain interference (any) | 83 Participants | 168 Participants | 85 Participants |
| Race/Ethnicity, Customized Race not white | 31 Participants | 61 Participants | 30 Participants |
| Race/Ethnicity, Customized Race white | 363 Participants | 728 Participants | 365 Participants |
| Region of Enrollment United States | 396 participants | 794 participants | 398 participants |
| Sex: Female, Male Female | 111 Participants | 243 Participants | 132 Participants |
| Sex: Female, Male Male | 283 Participants | 547 Participants | 264 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 394 | 1 / 390 |
| other Total, other adverse events | 234 / 394 | 154 / 390 |
| serious Total, serious adverse events | 21 / 394 | 8 / 390 |
Outcome results
Primary
Number of Patients With Atrial Arrhythmia
The occurrence of postoperative atrial arrhythmias
Time frame: From the end of surgery to postoperative day 5
Population: 2 patients had no Atrial Arrhythmia data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexmedetomidine | Number of Patients With Atrial Arrhythmia | 121 Participants |
| Placebo | Number of Patients With Atrial Arrhythmia | 134 Participants |
Comparison: Hypothesis: dexmedetomidine would reduce the incidence of postoperative atrial arrhythmias.p-value: 0.3497.8% CI: [0.72, 1.15]Regression, Logistic
Primary
Number of Patients With Delirium
The occurrence of postoperative delirium
Time frame: From the end of surgery to postoperative day 5
Population: Delirium data is not available in 18 patients.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexmedetomidine | Number of Patients With Delirium | 67 Participants |
| Placebo | Number of Patients With Delirium | 46 Participants |
Comparison: hypothesis: Dexmedetomidine may reduce the incidence of postoperative delirium.p-value: 0.02697.8% CI: [0.99, 2.23]Regression, Logistic
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.
Time frame: From the end of surgery to postoperative day 5
Population: Acute kidney injury data is not available in 16 patients.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dexmedetomidine | Number of Patients With Acute Kidney Injury | No risk | 348 Participants |
| Dexmedetomidine | Number of Patients With Acute Kidney Injury | stage1 | 33 Participants |
| Dexmedetomidine | Number of Patients With Acute Kidney Injury | Stage2 | 4 Participants |
| Dexmedetomidine | Number of Patients With Acute Kidney Injury | Stage3 | 4 Participants |
| Placebo | Number of Patients With Acute Kidney Injury | Stage3 | 1 Participants |
| Placebo | Number of Patients With Acute Kidney Injury | No risk | 359 Participants |
| Placebo | Number of Patients With Acute Kidney Injury | Stage2 | 0 Participants |
| Placebo | Number of Patients With Acute Kidney Injury | stage1 | 29 Participants |
p-value: 0.1497.5% CI: [0.84, 2.34]Regression, Logistic
Secondary
Number of Patients With Incisional Pain
Patients were evaluated at 90 days by modified Brief Pain Inventory.
Time frame: 90 days after surgery
Population: Incisional pain at 90 days is not available in 205 patients.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexmedetomidine | Number of Patients With Incisional Pain | 79 Participants |
| Placebo | Number of Patients With Incisional Pain | 93 Participants |
p-value: 0.2997.5% CI: [0.65, 1.16]Regression, Logistic