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| Name | Class |
|---|---|
| Federal University of Paraíba | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Dexmedetomidine | Active Comparator | The patient will receive Dexmedetomidine, at the rate of 0,3μg/ kg/h, in continuous intravenous infusion from the initiation of the anesthesia up to the end of the procedure, except during the cardiopulmonary by-pass. |
|
| Group 0,9% Saline | Placebo Comparator | The patient will receive a 0,9% saline, in continuous intravenous infusion, from the initiation of the anesthesia up to the end of the procedure, except during the cardiopulmonary by-pass. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain 24 hours after 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). | 24 hours after the cardiac surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption. | Opioid used for the pain control. This will be noted in the medical record. | During the first 24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Time from the end of surgery to extubation. | 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. | During the first 24 hours. |
| Bleeding. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luiz Antônio Machado César | Contact | 551126617585 | cappesq.adm@hc.fm.usp.br | |
| Lígia Ferreira dos santos | Contact | 558399189-6525 | ligiafs1@usp.br |
| Name | Affiliation | Role |
|---|---|---|
| Luiz Antônio Machado César | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nova Esperança University Hospital | Recruiting | João Pessoa | Paraíba | 58.015-345 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31303717 | Background | Kundra S, Taneja S, Choudhary AK, Katyal S, Garg I, Roy R. Effect of a low-dose dexmedetomidine infusion on intraoperative hemodynamics, anesthetic requirements and recovery profile in patients undergoing lumbar spine surgery. J Anaesthesiol Clin Pharmacol. 2019 Apr-Jun;35(2):248-253. doi: 10.4103/joacp.JOACP_338_18. | |
| 29678158 |
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This will be decided, after data collection stars.
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D003324 | Coronary Artery Disease |
| D006349 | Heart Valve Diseases |
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 0,9% Saline | Drug | 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. |
|
Bleeding after the surgery. This will be noted in the medical record.
| During the first 24 hours. |
| Cardiac arrhythmias. | Occurrence of cardiac arrhythmias. This will be noted in the medical record. | During the first 24 hours. |
| Serum creatinine and urea. | The serum level of creatinine and urea will be observed, in the usual daily measure. This will be noted in the medical record. | During the first 24 hours. |
| Heart Institute (InCor), Univ. of Sao Paulo Medical School | Recruiting | São Paulo | 05403000 | Brazil |
|
| Bielka K, Kuchyn I, Babych V, Martycshenko K, Inozemtsev O. Dexmedetomidine infusion as an analgesic adjuvant during laparoscopic small es, Cyrillicholecystectomy: a randomized controlled study. BMC Anesthesiol. 2018 Apr 20;18(1):44. doi: 10.1186/s12871-018-0508-6. |
| 10735784 | Background | Talke P, Chen R, Thomas B, Aggarwall A, Gottlieb A, Thorborg P, Heard S, Cheung A, Son SL, Kallio A. The hemodynamic and adrenergic effects of perioperative dexmedetomidine infusion after vascular surgery. Anesth Analg. 2000 Apr;90(4):834-9. doi: 10.1097/00000539-200004000-00011. |
| 1854025 | Background | Aho MS, Erkola OA, Scheinin H, Lehtinen AM, Korttila KT. Effect of intravenously administered dexmedetomidine on pain after laparoscopic tubal ligation. Anesth Analg. 1991 Aug;73(2):112-8. doi: 10.1213/00000539-199108000-00002. |
| 18660652 | Background | Carollo DS, Nossaman BD, Ramadhyani U. Dexmedetomidine: a review of clinical applications. Curr Opin Anaesthesiol. 2008 Aug;21(4):457-61. doi: 10.1097/ACO.0b013e328305e3ef. |
| 30235728 | Background | Kotfis K, Strzelbicka M, Zegan-Baranska M, Safranow K, Brykczynski M, Zukowski M, Ely EW; POL-BPS Study Group. Validation of the behavioral pain scale to assess pain intensity in adult, intubated postcardiac surgery patients: A cohort observational study - POL-BPS. Medicine (Baltimore). 2018 Sep;97(38):e12443. doi: 10.1097/MD.0000000000012443. |
| 30184039 | Background | Habibi V, Kiabi FH, Sharifi H. The Effect of Dexmedetomidine on the Acute Pain After Cardiothoracic Surgeries: A Systematic Review. Braz J Cardiovasc Surg. 2018 Jul-Aug;33(4):404-417. doi: 10.21470/1678-9741-2017-0253. |
| 23276596 | Background | Hall R. Identification of inflammatory mediators and their modulation by strategies for the management of the systemic inflammatory response during cardiac surgery. J Cardiothorac Vasc Anesth. 2013 Oct;27(5):983-1033. doi: 10.1053/j.jvca.2012.09.013. Epub 2012 Dec 29. No abstract available. |
| 27737403 | Background | Brandao PG, Lobo FR, Ramin SL, Sakr Y, Machado MN, Lobo SM. Dexmedetomidine as an Anesthetic Adjuvant in Cardiac Surgery: a Cohort Study. Braz J Cardiovasc Surg. 2016 May-Jun;31(3):213-218. doi: 10.5935/1678-9741.20160043. |
| 19713256 | Background | Candiotti KA, Bergese SD, Bokesch PM, Feldman MA, Wisemandle W, Bekker AY; MAC Study Group. Monitored anesthesia care with dexmedetomidine: a prospective, randomized, double-blind, multicenter trial. Anesth Analg. 2010 Jan 1;110(1):47-56. doi: 10.1213/ane.0b013e3181ae0856. Epub 2009 Aug 27. |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |