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

Sponsor

University of Sao Paulo (Other)

Overall Status

Recruiting

CT.gov ID

NCT05079672

Collaborator

Federal University of Paraíba (Other)

102

Enrollment

Locations

Arms

24.1

Anticipated Duration (Months)

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiopathy Coronary Artery Disease Valve Heart Disease Pain	Drug: Dexmedetomidine Drug: 0,9% Saline	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

102 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Prevention

Official Title:

Efficacy and Safety of Dexmedetomidine in the Analgesic Prophylaxis , in Patients Undergoing Cardiovascular Surgery: Randomized Clinical Trial

Actual Study Start Date :

Oct 7, 2021

Anticipated Primary Completion Date :

Oct 10, 2022

Anticipated Study Completion Date :

Oct 10, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Pain 24 hours after cardiac surgery. [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).

Secondary Outcome Measures

Opioid consumption. [During the first 24 hours.]
Opioid used for the pain control. This will be noted in the medical record.

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nova Esperança University Hospital	João Pessoa	Paraíba	Brazil	58.015-345
2	Heart Institute (InCor), Univ. of Sao Paulo Medical School	Sao Paulo		Brazil	05403000