Skip to main content
Clinical Trials/NCT02466542
NCT02466542CompletedPhase 4

Analgesic Effect of Intraoperative Esmolol in Mastectomies: Single Center, Prospective, Double-blind, Randomized and Placebo Controlled Study

Hospital de Base1 site in 1 country60 target enrollmentStarted: June 2015Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Pain Scores on the Visual Analogue Scale

Study Overview

Brief Summary

This study aims to compare the quality of perioperative analgesia of esmolol in patients undergoing mastectomy.

Detailed Description

Controlled hypotension is an anesthetic-surgical approach that matches the reversible and deliberate reduction in blood pressure during surgery period which aims to achieve values below 50% of normal values or mean arterial pressure (MAP) from 50 to 65 mmHg.

This technique is especially beneficial in patients undergoing procedures requiring control of bleeding for proper surgical field. The method provides a better view of anatomical structures, reduced surgical time and a significant decrease in the need for blood transfusions, with the added benefit of preventing possible complications from it.

Several drugs have been used in this scenario, as halogenated, opioids, alpha-2-agonists and beta-blockers, among which the esmolol emerges as effective and promising drug.

Esmolol is a selective beta-blocker whose action inhibits preferably the beta type 1 receptors with decreased heart rate (HR) and cardiac inotropic and consequent decrease in consumption of myocardial oxygen. Its half-life of distribution is approximately 2 minutes, the elimination half-life of 9 minutes with 55% protein bound. The duration is short due to rapid metabolism by hydrolysis by esterases in plasma and results in an inactive metabolite with negligible amounts of methanol. It has low solubility, which limits their passage through the blood-brain and placental barrier. Thanks to these features, the esmolol constitutes the most appropriate beta-blocker for intravenous use under continuous infusion.

The use of a selective beta-blocking agent continuously infused intraoperative period as well as promoting adequate blood pressure control in the controlled hypotension, it has additional advantages over other anesthetic agents, such as cardioprotection obtained by suppressing the cardiovascular response to catecholamines released during stress surgical and sympathetic stimulation resulting from laryngoscopy and tracheal intubation. The suppression of cardiovascular adrenergic response allows better coronary perfusion with proven benefits in reducing the incidence of perioperative myocardial ischemia and influence on mortality and morbidity of patients, especially coronary and high risk for ischemic phenomena. There are also several studies that demonstrate the importance of esmolol in the control and prevention of sympathetic response during extubation, better hemodynamics during induction, maintenance and emergence from anesthesia, fewer complications, lower incidence of perioperative nausea, time decreased from room to stay anesthetic recovery and, due to reduced cardiac work, action prolongation of neuromuscular blockers and opioids, saving their use. There are still ongoing studies with important indications that there is potentiation of analgesia and the hypnotic component of anesthesia with the use of esmolol.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Female patients, aged 18 to 75 years, electively scheduled to perform mastectomy in the Base Hospital of the Federal District;
  • Physical State 1 or 2 the American Society of Anesthesiology (ASA);

Exclusion Criteria

  • Patients under the age of 18 years and above 75 years;
  • Patients with unstable angina
  • Patient with poorly controlled asthma
  • Substance abuse
  • Sinus bradycardia
  • Heart failure, greater than first degree atrioventricular block
  • Pregnant women
  • Patients with allergy to dipyrone, morphine;
  • Patients with chronic pain;
  • Patients with severe hepatic disease;
  • Patients with severe kidney disease;
  • Patients with neurological diseases;
  • Included patients in other clinical studies currently or in the past three months under general anesthesia;
  • Patients who refuse to participate in the study;
  • Any other condition that, in the opinion of the investigator, may pose a risk to the patient or interfere with the study objectives;

Arms & Interventions

Placebo group

Placebo Comparator

Patients in placebo group will receive general balanced inhaled anesthesia with sevoflurane and remifentanil and a saline 0,9% infusion pump.

Intervention: Placebo group (Drug)

Esmolol group

Active Comparator

Patients in esmolol group will receive general balanced inhaled anesthesia with sevoflurane and remifentanil and a bolus infection of esmolol 500 mgc/kg followed by a continuous infusion of esmolol 100 mcg/kg/min

Intervention: Esmolol group (Drug)

Outcomes

Primary Outcomes

Pain Scores on the Visual Analogue Scale

Time Frame: Within the first 24 hours after surgery

Quantify pain by Visual Analogue Scale (VAS, ranging from 0 to 10 cm, zero being found when the patient is no pain and ten, with maximum or un bearable pain

Secondary Outcomes

  • Pain Scores on the Verbal Rating Scale(Within the first 24 hours after surgery)
  • Analgesics consumption in post-operative(Within the first 24 hours after surgery)
  • Analgesic consumption during surgery(During the surgery)
  • Number of participants with adverse events as a measure of safety and tolerability(Within the first 24 hours after surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Fabricio Tavares Mendonca

MD, TSA

Hospital de Base

Study Sites (1)

Loading locations...

Similar Trials