Intramuscular Ephedrine in the Prevention of Hypotension in Patients Undergoing Spinal Anesthesia

NCT05498857 | Unknown Phase 4

• 1 other identifier: i.m. ephedrine
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief Summary

Subarachnoid anesthesia is an alternative and usually the first choice for many surgical procedures. It is a simple and safe procedure, however it can present complications such as hypotension and bradycardia. In this sense, ephedrine, an alpha and beta agonist agent, commonly used as rescue therapy for these events, is also potentially useful for prophylaxis of this unwanted effect and for less hemodynamic variation when preventively administered via the intramuscular route. Two groups will be divided: intramuscular ephedrine (0.5 mg/kg) and placebo. The variables analyzed and compared will be the incidence of hypotension and bradycardia, variation in mean and systolic blood pressure, heart rate, in addition to side effects. The main objective is to verify if the use of intramuscular ephedrine prior to spinal block is able to reduce the incidence of hypotension.

Conditions

Ephedrine; Intramuscular; Hypotension; Spinal Anesthesia

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events as hypotension

  Intraoperative hemodynamic stability analysis through the incidence of bradycardia, hypotension and consumed vasopressors

  During surgery

Study Arms (2)

Ephedrine group

ACTIVE COMPARATOR

Patients will receive intramuscular ephedrine 0,5 mg/kg before spinal anesthesia

Drug: Intramuscular ephedrine; Drug: Placebo

Placebo group

PLACEBO COMPARATOR

Patients will receive intramuscular saline before spinal anesthesia

Drug: Intramuscular ephedrine; Drug: Placebo

Interventions

Intramuscular ephedrine DRUG

Patients will receive prophylactic intramuscular ephedrine plus standard spinal anesthesia

Ephedrine group; Placebo group

Placebo DRUG

Patients will receive prophylactic intramuscular saline plus standard spinal anesthesia

Ephedrine group; Placebo group

Eligibility Criteria

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

You may qualify if:

• Patients over 18 years old, electively scaled for surgery requiring neuraxial block, with programming of spinal anesthesia.
• Physical State 1, 2 or 3 of the American Society of Anesthesiology (ASA)

You may not qualify if:

• Patients taking prophylactic or therapeutic anticoagulation, except respecting the allowed range;
• Patients with atrioventricular block
• Patients with cardiac arrhythmias
• Patients with heart failure;
• Patients with renal disease
• Patients with liver disease
• Patient carrying or suspecting any type of systemic infection or located in a puncture site;
• Patients who refuse to participate in the study after presenting the free and informed consent form;

Sponsors & Collaborators

• Hospital de Base: lead

Study Sites (1)

Hospital de Base do Distrito Federal

Brasília, Federal District, 70330-150, Brazil

RECRUITING

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Fabricio T Mendonca, MD, MSc, PhD

  Hospital de Base do Distrito Federal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabricio T Mendonca, MD, MSc, PhD

CONTACT

5561981882640; correiodofabricio@gmail.com

Study Design

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

Model Details: Prospective, randomized, double-blind and placebo-controlled trial

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 12, 2022
• Study Start: July 15, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: August 12, 2022

Record last verified: 2022-08

Locations

BR (1)