AzTrials
AzTrials

CardiopathyPhase 4NCT05079672

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

A Phase 4 study testing Dexmedetomidine and 0,9% Saline in people with Cardiopathy and Coronary Artery Disease, run by University of Sao Paulo at 2 sites in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dexmedetomidine and 0,9% Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
102 participants
Where
2 sitesBrazil
Study dates
7 Oct 2021to 10 Oct 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Congenital heart disease
  • Infective endocarditis
  • Acute myocardial infarction (<two weeks)
  • Pregnancy
  • Cancer
  • Left ventricle ejection fraction < 40%
Show all 14Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Luiz Antônio Machado César contact

551126617585

cappesq.adm@hc.fm.usp.br

Lígia Ferreira dos santos contact

558399189-6525

ligiafs1@usp.br

Brazil2 sites, 2 recruiting

  • Nova Esperança University Hospital

    João Pessoa, Paraíba, 58.015-345

    Luiz Antônio Machado César, 551126617585, cappesq.adm@hc.fm.usp.br

    Lígia Ferreira dos santos, 5583991896525, ligiafs1@usp.br

    Recruiting

  • Heart Institute (InCor), Univ. of Sao Paulo Medical School

    São Paulo, 05403000

    Luiz A Machado Cesar, Phd, MD, 551130695387, luiz.cesar@incor.usp.br

    Bruno M Mioto, MD, 551130695437, brunomioto@gmail.com

    Recruiting

Other trials in Brazil

About this study

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.

Read the 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.

Being tested
Dexmedetomidine, 0,9% Saline
Keywords
Dexmedetomidine, Cardiac surgery, Analgesia
Medical subject headings
Heart Diseases, Coronary Artery Disease, Heart Valve Diseases, Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    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.

  • 0,9% SalineDrug

    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.

Study groups in NCT05079672
Study groupRoleWhat they receive
Group DexmedetomidineActive 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.
Receives: Drug: Dexmedetomidine
Group 0,9% SalinePlacebo 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.
Receives: Drug: 0,9% Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 24 hours after the cardiac surgery.

Secondary outcomes (1)

  1. Opioid consumption.

    Opioid used for the pain control. This will be noted in the medical record.

    Measured: During the first 24 hours.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2021
  2. Study start7 Oct 2021
  3. Primary completion10 Oct 2022 (estimated)
  4. Study completion10 Oct 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
102 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05079672
Sponsor's protocol ID
SDCDT014/19/113
Status last verified
Oct 2021
First submitted
3 Oct 2021
Last updated
20 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: This will be decided, after data collection stars.

Publications

  • 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.

    PubMed 31303717

  • 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.

    PubMed 29678158

  • 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.

    PubMed 10735784

  • 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.

    PubMed 1854025

  • 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.

    PubMed 18660652

  • 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.

    PubMed 30235728

  • 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.

    PubMed 30184039

  • 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.

    PubMed 23276596

  • 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.

    PubMed 27737403

  • 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.

    PubMed 19713256

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexmedetomidine and 0,9% Saline in people with Cardiopathy and Coronary Artery Disease, run by University of Sao Paulo at 2 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Luiz Antônio Machado César (551126617585, cappesq.adm@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain 24 hours after cardiac surgery. (time frame: 24 hours after the cardiac surgery.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05079672, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in