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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03984526
Other study ID # AJIRB-MED-THE-18-343
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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