Atropine or Ephedrine Pretreatment for Preventing Bradycardia in Elderly Patients

Bradycardia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03984526
• Other study ID #: AJIRB-MED-THE-18-343
• Status: Completed
• Phase: Phase 4
• Start date: June 25, 2019
• Est. completion date: September 15, 2020

Study information

• Verified date: February 2021
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: September 15, 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Spinal
• Bradycardia
• Dexmedetomidine

Intervention

Drug:
• normal saline
intravenous normal saline pretreatment at the onset of dexmedetomidine infusion
• atropine 0.5mg
intravenous atropine 0.5mg pretreatment at the onset of dexmedetomidine infusion
• ephedrine 8mg
intravenous ephedrine 8mg pretreatment at the onset of dexmedetomidine infusion

Locations

Country	Name	City	State
Korea, Republic of	Ajou universitiy school of medicine	Suwon-si	Gyeong-gi Do

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of intervention for bradycardia	The number of treatment for bradycardia which is defined as heart rate under 50 beats per minute	for 1 hour after spinal anesthesia
Secondary	The incidence of intervention for hypotension	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	for 1 hour after spinal anesthesia
Secondary	Systolic/ mean/ diastolic blood pressure	Systolic/ mean/ diastolic blood pressure	for 1 hour after spinal anesthesia