Skip to main content
OpenTrials
Completed

NCT Number: NCT03984526

Atropine or Ephedrine Pretreatment for Preventing Bradycardia in Elderly Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ajou universitiy school of medicine

Suwon, Gyeong-gi Do, 16499, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesiologists (ASA) classification I-II
  • Undergoing orthopedic surgery under spinal anesthesia

Exclusion criteria

  • Contraindication for spinal anesthesia
  • Atrial fibrillation, atrial flutter
  • Cardiac valve disease
  • Neurologic disease
  • initial systolic blood pressure in operating room > 160mmHg

Treatment and study plan

normal saline

Drug

intravenous normal saline pretreatment at the onset of dexmedetomidine infusion

atropine 0.5mg

Drug

intravenous atropine 0.5mg pretreatment at the onset of dexmedetomidine infusion

ephedrine 8mg

Drug

intravenous ephedrine 8mg pretreatment at the onset of dexmedetomidine infusion

Primary outcomes

  1. The incidence of intervention for bradycardia

    Time frame: for 1 hour after spinal anesthesia

    The number of treatment for bradycardia which is defined as heart rate under 50 beats per minute

Secondary outcomes

  1. The incidence of intervention for hypotension

    Time frame: for 1 hour after spinal anesthesia

    The number of treatment for hypotension which is defined as systolic blood pressure in under 100 mmHg or systolic blood pressure under the 30% of baseline systolic blood pressure

  2. Systolic/ mean/ diastolic blood pressure

    Time frame: for 1 hour after spinal anesthesia

    Systolic/ mean/ diastolic blood pressure

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 13, 2019
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.