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

October 14, 2021 updated by: Luiz Antonio M. Cesar, University of Sao Paulo

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

102

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Lígia Ferreira dos santos
  • Phone Number: 558399189-6525
  • Email: ligiafs1@usp.br

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403000
        • Recruiting
        • Heart Institute (InCor), Univ. of Sao Paulo Medical School
    • Paraíba
      • João Pessoa, Paraíba, Brazil, 58.015-345
        • Recruiting
        • Nova Esperança University Hospital
        • Contact:
        • Contact:
          • Lígia Ferreira dos santos
          • Phone Number: 5583991896525
          • Email: ligiafs1@usp.br
        • Principal Investigator:
          • Luiz Antônio Machado César
        • Sub-Investigator:
          • Lígia Ferreira dos Santos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group Dexmedetomidine
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.
Drug: Dexmedetomidine
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.
PLACEBO_COMPARATOR: Group 0,9% Saline
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.
Drug: 0,9% Saline
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain 24 hours after cardiac surgery.
Time Frame: 24 hours after the 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption.
Time Frame: During the first 24 hours.
Opioid used for the pain control. This will be noted in the medical record.
During the first 24 hours.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from the end of surgery to extubation.
Time Frame: During the first 24 hours.
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.
Time Frame: During the first 24 hours.
Bleeding after the surgery. This will be noted in the medical record.
During the first 24 hours.
Cardiac arrhythmias.
Time Frame: During the first 24 hours.
Occurrence of cardiac arrhythmias. This will be noted in the medical record.
During the first 24 hours.
Serum creatinine and urea.
Time Frame: During the first 24 hours.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Federal University of Paraíba

Investigators

  • Principal Investigator: Luiz Antônio Machado César, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 7, 2021

Primary Completion (ANTICIPATED)

October 10, 2022

Study Completion (ANTICIPATED)

October 10, 2023

Study Registration Dates

First Submitted

October 3, 2021

First Submitted That Met QC Criteria

October 3, 2021

First Posted (ACTUAL)

October 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 20, 2021

Last Update Submitted That Met QC Criteria

October 14, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDCDT014/19/113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This will be decided, after data collection stars.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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