Atropine or Ephedrine Pretreatment for Preventing Bradycardia in Elderly Patients

Phase 4

Completed

• Conditions: Bradycardia; Anesthesia, Spinal; Dexmedetomidine
• Interventions: Drug: atropine 0.5mg; Drug: ephedrine 8mg; Drug: normal saline

• Registration Number: NCT03984526
• Lead Sponsor: Ajou University School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-11
• Study First Submitted QC: 2019-06-11
• Study First Posted: 2019-06-13
• Study Start: 2019-06-25
• Primary Completion: 2020-09-15
• Study Completion: 2020-09-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atropine group	atropine 0.5mg	intravenous atropine 0.5mg pretreatment
Ephedrine group	ephedrine 8mg	intravenous ephedrine 8mg pretreatment
Control group	normal saline	intravenous normal saline pretreatment

Primary Outcome Measures

Name	Time	Method
The incidence of intervention for bradycardia	for 1 hour after spinal anesthesia	The number of treatment for bradycardia which is defined as heart rate under 50 beats per minute

Secondary Outcome Measures

Name	Time	Method
The incidence of intervention for hypotension	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
Systolic/ mean/ diastolic blood pressure	for 1 hour after spinal anesthesia	Systolic/ mean/ diastolic blood pressure

Trial Locations

Locations (1)

Ajou universitiy school of medicine; 🇰🇷 Suwon-si, Gyeong-gi Do, Korea, Republic of