Efficacy and Safety of Dexmedetomidine in the Analgesic Prophylaxis in Patients Undergoing Cardiovascular Surgery

  • STATUS
    Recruiting
  • End date
    Oct 10, 2023
  • participants needed
    102
  • sponsor
    University of Sao Paulo
Updated on 28 October 2021
anesthesia
analgesia
dexmedetomidine
sedative
cardiopulmonary bypass
acute pain
pain relieving
cardiovascular surgery

Summary

Acute pain is one of the complications after cardiothoracic surgeries . It can delay patientsrecovery and may increase patientsmorbity and mortality. This study intends to evaluate Dexmedetomidine, a highly selective - 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.

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 0,3g/ 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.

Details
Condition Cardiac Disease, ache, cardiac disorders, Heart Valve Disease, Coronary heart disease, Acute Pain Service, Cardiac Ischemia, Coronary Artery Disease, heart diseases, heart disorder, Post-Surgical Pain, Myocardial Ischemia, cardiac disorder, Heart Disease, cardiac diseases, VALVULAR HEART DISEASE, Heart disease, Pain (Pediatric), Pain
Treatment Dexmedetomidine, 0,9% saline
Clinical Study IdentifierNCT05079672
SponsorUniversity of Sao Paulo
Last Modified on28 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients at least 18 years old and who are undergoing cardiac procedures (coronary artery bypass, valve replacement or combined procedure), with cardiopulmonary bypass

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
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