Cardiopathy, Coronary Artery Disease, Valve Heart Disease, Pain
Conditions
Keywords
Dexmedetomidine, Cardiac surgery, Analgesia
Brief summary
Acute pain is one of the complications after cardiothoracic surgeries . It can delay patients´recovery and may increase patients´morbity and mortality. This study intends to evaluate Dexmedetomidine, a highly selective α- 2 receptor agonist, that is currently applied safely and efficiently in intraoperative cardiac surgery. It has analgesic, sedative, anxiolytic and sympatholytic properties, without respiratory- depressant effect. The aim of this study is to investigate whether the intraoperative use of dexmedetomidine is better than the standard analgesia used in the intraoperative period to reduce pain and the consequences of it.
Detailed description
This project is a prospective, double-blinded and randomized clinical trial. Eligible participants are assigned in a 1:1 ratio to either the intervention group (Group Dexmedetomidine) or control group (Group Saline 0,9%), after written informed consent to be obtained. The patients will undergo elective cardiac surgery, with extracorporeal circulation. In the operating room, patients will be monitored for pulse oximetry, invasive blood pressure, electrocardiograms, capnography, central venous pressure and nasopharyngeal temperature probe. Induction of anesthesia is performed with intravenous midazolam, fentanyl, etomidate and neuromuscular blocking agent. Anesthesia is maintained with sevoflurane. Dexmedetomidine, at the rate of 0,3μg/ kg/h, or placebo will be infused from the initiation of the anesthesia up to the end of the procedure, except during the cardiopulmonary by-pass. Placebo is a 0,9% saline. The follow up of the assessment of the groups will extend to the postoperative ICU, where data will be collected, during the first 24 hours after surgery.
Interventions
DRUGDexmedetomidine
Dexmedetomidine injectable solution, at the rate of 0,3μg/ kg/h, will be infused from the initiation of the anesthesia up to the end of the procedure, except during the cardiopulmonary by-pass.
DRUG0,9% Saline
Saline 0,9% will be infused from the initiation of the anesthesia up to the end of the procedure, except during the cardiopulmonary by- pass.
Sponsors
Federal University of Paraíba
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients at least 18 years old and who are undergoing cardiac procedures (coronary artery bypass, valve replacement or combined procedure), with cardiopulmonary by- pass.
Exclusion criteria
* Congenital heart disease * Infective endocarditis * Acute myocardial infarction (\<two weeks) * Pregnancy * Cancer * Left ventricle ejection fraction \< 40% * Cardiogenic shock * Emergent procedure * Use of vasopressor and/or inotrope, in the preoperative * Liver disfunction * Renal replacement therapy * Nephrectomy * Previous renal transplantation * Patients who are participating in another clinical research
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain 24 hours after cardiac surgery. | 24 hours after the cardiac surgery. | The assessment of pain intensity, in patients with self- reporting, will be done by: Numeric Rating Scale (NRS) 0- 10. Possible score range from 0 (no pain) to 10 (worst pain ever ). The assessment of pain intensity, in patients on mechanical ventilation, will be done by: Behavioral Pain Scale, through facial expression (score 1-4), upper limb movement (score 1-5) and compliance with mechanical ventilation (score 1-3). Possible score range from 3 (no pain) to 12 (maximum pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption. | During the first 24 hours. | Opioid used for the pain control. This will be noted in the medical record. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time from the end of surgery to extubation. | During the first 24 hours. | This interval will be observed if the patient is not extubated at the end of the surgery. This will be noted in the medical record. |
| Bleeding. | During the first 24 hours. | Bleeding after the surgery. This will be noted in the medical record. |
| Cardiac arrhythmias. | During the first 24 hours. | Occurrence of cardiac arrhythmias. This will be noted in the medical record. |
| Serum creatinine and urea. | During the first 24 hours. | The serum level of creatinine and urea will be observed, in the usual daily measure. This will be noted in the medical record. |
Countries
Brazil
Contacts
Primary ContactLuiz Antônio Machado César
Backup ContactLígia Ferreira dos santos
Outcome results
None listed