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Atropine or Ephedrine Pretreatment for Preventing Bradycardia in Elderly Patients

NCT03984526 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2021-02-04

No results posted yet for this study

Summary

Spinal anesthesia is widely used for lower extremity surgery, and sedation is often required during surgery. For sedation, propofol, midazolam and dexmedetomidine are frequently used. Dexmedetomidine is a highly selective alpha 2 receptor agonist, and has sedating and analgesic effect. Compared with propofol and midazolam, it has little or no respiratory inhibition and hemodynamically stable. It also has the effect of reducing delirium in the elderly. Dexmedetomidine has also been reported to prolong the duration of sensory and motor blockade effects of spinal anesthesia. However, several studies have reported that administration of dexmedetomidine in spinal anesthesia increases the incidence of bradycardia.

In a study of healthy young adults, concurrent administration of atropine with dexmedetomidine in spinal anesthesia significantly reduced the frequency of bradycardia requiring treatment. However, in elderly patients, it is often reported that there is little response to atropine in bradycardia, and ephedrine is more effective in treating bradycardia than atropine in the elderly.

The investigators therefore compared ephedrine and atropine as pretreatment to reduce the incidence of bradycardia when using dexmedetomidine as a sedative in elderly patients undergoing spinal anesthesia.

Conditions

  • Anesthesia, Spinal
  • Dexmedetomidine
  • Bradycardia

Interventions

DRUG

normal saline

intravenous normal saline pretreatment at the onset of dexmedetomidine infusion

DRUG

atropine 0.5mg

intravenous atropine 0.5mg pretreatment at the onset of dexmedetomidine infusion

DRUG

ephedrine 8mg

intravenous ephedrine 8mg pretreatment at the onset of dexmedetomidine infusion

Sponsors & Collaborators

  • Ajou University School of Medicine

    lead OTHER

Principal Investigators

  • yun jeong chae, Ph.D · Ajou University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-25
Primary Completion
2020-09-15
Completion
2020-09-15

Countries

  • South Korea

Study Locations

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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 NCT03984526 on ClinicalTrials.gov