Efficacy and Safety of Dexmedetomidine in the Analgesic Prophylaxis , in Patients Undergoing Cardiovascular Surgery
1 other identifier
interventional
102
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2021
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2021
CompletedStudy Start
First participant enrolled
October 7, 2021
CompletedFirst Posted
Study publicly available on registry
October 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2023
CompletedOctober 20, 2021
October 1, 2021
1 year
October 3, 2021
October 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Opioid consumption.
During the first 24 hours.
Other Outcomes (4)
Time from the end of surgery to extubation.
During the first 24 hours.
Bleeding.
During the first 24 hours.
Cardiac arrhythmias.
During the first 24 hours.
- +1 more other outcomes
Study Arms (2)
Group Dexmedetomidine
ACTIVE COMPARATORThe 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 COMPARATORThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patients at least 18 years old and who are undergoing cardiac procedures (coronary artery bypass, valve replacement or combined procedure), with cardiopulmonary by- pass.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Sao Paulolead
- Federal University of Paraíbacollaborator
Study Sites (2)
Nova Esperança University Hospital
João Pessoa, Paraíba, 58.015-345, Brazil
Heart Institute (InCor), Univ. of Sao Paulo Medical School
São Paulo, 05403000, Brazil
Related Publications (10)
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.
PMID: 31303717BACKGROUNDBielka 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.
PMID: 29678158BACKGROUNDTalke 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.
PMID: 10735784BACKGROUNDAho 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.
PMID: 1854025BACKGROUNDCarollo 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.
PMID: 18660652BACKGROUNDKotfis 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.
PMID: 30235728BACKGROUNDHabibi 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.
PMID: 30184039BACKGROUNDHall 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.
PMID: 23276596BACKGROUNDBrandao 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.
PMID: 27737403BACKGROUNDCandiotti 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.
PMID: 19713256BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luiz Antônio Machado César
University of Sao Paulo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated Professor of Cardiology
Study Record Dates
First Submitted
October 3, 2021
First Posted
October 15, 2021
Study Start
October 7, 2021
Primary Completion
October 10, 2022
Study Completion
October 10, 2023
Last Updated
October 20, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share
This will be decided, after data collection stars.