Pain Clinical Trial
Official title:
Efficacy and Safety of Dexmedetomidine in the Analgesic Prophylaxis , in Patients Undergoing Cardiovascular Surgery: Randomized Clinical Trial
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.
Status | Recruiting |
Enrollment | 102 |
Est. completion date | October 10, 2023 |
Est. primary completion date | October 10, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Nova Esperança University Hospital | João Pessoa | Paraíba |
Brazil | Heart Institute (InCor), Univ. of Sao Paulo Medical School | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo | Federal University of Paraíba |
Brazil,
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Bielka K, Kuchyn I, Babych V, Martycshenko K, Inozemtsev O. Dexmedetomidine infusion as an analgesic adjuvant during laparoscopic ?holecystectomy: a randomized controlled study. BMC Anesthesiol. 2018 Apr 20;18(1):44. doi: 10.1186/s12871-018-0508-6. — View Citation
Brandão 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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | |
Other | Bleeding. | Bleeding after the surgery. This will be noted in the medical record. | During the first 24 hours. | |
Other | Cardiac arrhythmias. | Occurrence of cardiac arrhythmias. This will be noted in the medical record. | During the first 24 hours. | |
Other | 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. | |
Primary | 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. | |
Secondary | Opioid consumption. | Opioid used for the pain control. This will be noted in the medical record. | During the first 24 hours. |
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