MedTrace Logo

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

NCT05498857 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2022-08-12

No results posted yet for this study

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

Interventions

DRUG

Intramuscular ephedrine

Patients will receive prophylactic intramuscular ephedrine plus standard spinal anesthesia

DRUG

Placebo

Patients will receive prophylactic intramuscular saline plus standard spinal anesthesia

Sponsors & Collaborators

  • Hospital de Base

    lead OTHER

Principal Investigators

  • Fabricio T Mendonca, MD, MSc, PhD · Hospital de Base do Distrito Federal

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-15
Primary Completion
2023-07-31
Completion
2023-07-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05498857 on ClinicalTrials.gov