Analgesic Effect of Intraoperative Esmolol in Mastectomies

NCT02466542 | Completed Phase 4 DMC

• 1 other identifier: HBase
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Pain

Keywords

Esmolol; Pain; Anesthesia; Analgesia

Outcome Measures

Primary Outcomes (1)

• Pain Scores on the Visual Analogue Scale

  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

  Within the first 24 hours after surgery

Secondary Outcomes (5)

• 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

  During the surgery

• Number of participants with adverse events as a measure of safety and tolerability

  Within the first 24 hours after surgery

Study Arms (2)

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.

Drug: Placebo group

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

Drug: Esmolol group

Interventions

Placebo group DRUG

Patients will receive regular general anesthesia

Also known as: Saline

Placebo group

Esmolol group DRUG

Patients will receive regular general anesthesia plus esmolol infusion

Also known as: Esmolol

Esmolol group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hospital de Base: lead

Study Sites (1)

Hospital de Base do Distrito Federal

Brasília, Federal District, 70680250, Brazil

Location

Related Publications (4)

• Celebi N, Cizmeci EA, Canbay O. [Intraoperative esmolol infusion reduces postoperative analgesic consumption and anaesthetic use during septorhinoplasty: a randomized trial]. Rev Bras Anestesiol. 2014 Sep-Oct;64(5):343-9. doi: 10.1016/j.bjan.2013.10.013. Epub 2014 Jun 21. Portuguese.

  PMID: 25168439 BACKGROUND

• Kim Y, Hwang W, Cho ML, Her YM, Ahn S, Lee J. The effects of intraoperative esmolol administration on perioperative inflammatory responses in patients undergoing laparoscopic gastrectomy: a dose-response study. Surg Innov. 2015 Apr;22(2):177-82. doi: 10.1177/1553350614532534. Epub 2014 May 6.

  PMID: 24803523 BACKGROUND

• Mendonca FT, Volpe Junior JF, Tramontini AJ, DE Carvalho LS, Sposito AC. Intraoperative infusion of esmolol reduces the incidence and intensity of post-mastectomy pain syndrome. Minerva Anestesiol. 2022 May;88(5):414-415. doi: 10.23736/S0375-9393.21.16152-8. Epub 2021 Oct 12. No abstract available.

  PMID: 34636226 DERIVED

• Mendonca FT, Tramontini AJ, Miake HI, Seixas LF, de Carvalho LSF, Sposito AC. Intra-operative esmolol and pain following mastectomy: A randomised clinical trial. Eur J Anaesthesiol. 2021 Jul 1;38(7):735-743. doi: 10.1097/EJA.0000000000001512.

  PMID: 33831899 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pain; Agnosia

Interventions

Sodium Chloride; esmolol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Fabricio T Mendonca, MD, TSA

  Hospital de Base do Distrito Federal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, TSA

Study Record Dates

• First Submitted: June 5, 2015
• First Posted: June 9, 2015
• Study Start: June 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: April 5, 2017

Record last verified: 2017-04

Locations

BR (1)