Clinical Trials Directory

Trials / Completed

CompletedNCT03984526

Atropine or Ephedrine Pretreatment for Preventing Bradycardia in Elderly Patients

Comparison of Effect of Atropine or Ephedrine Pretreatment for Preventing Bradycardia Under Sedation With Dexmedetomidine After Spinal Anesthesia in Elderly Patients

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
102 (actual)
Sponsor
Ajou University School of Medicine · Academic / Other
Sex
All
Age
65 Years – 100 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGnormal salineintravenous normal saline pretreatment at the onset of dexmedetomidine infusion
DRUGatropine 0.5mgintravenous atropine 0.5mg pretreatment at the onset of dexmedetomidine infusion
DRUGephedrine 8mgintravenous ephedrine 8mg pretreatment at the onset of dexmedetomidine infusion

Timeline

Start date
2019-06-25
Primary completion
2020-09-15
Completion
2020-09-15
First posted
2019-06-13
Last updated
2021-02-04

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT03984526. Inclusion in this directory is not an endorsement.