Atropine or Ephedrine Pretreatment for Preventing Bradycardia in Elderly Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-25

Study Completion Date

2020-09-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Anesthesia, Spinal Dexmedetomidine Bradycardia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control group

intravenous normal saline pretreatment

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

intravenous normal saline pretreatment at the onset of dexmedetomidine infusion

Atropine group

intravenous atropine 0.5mg pretreatment

Group Type EXPERIMENTAL

atropine 0.5mg

Intervention Type DRUG

intravenous atropine 0.5mg pretreatment at the onset of dexmedetomidine infusion

Ephedrine group

intravenous ephedrine 8mg pretreatment

Group Type EXPERIMENTAL

ephedrine 8mg

Intervention Type DRUG

intravenous ephedrine 8mg pretreatment at the onset of dexmedetomidine infusion

Interventions

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normal saline

intravenous normal saline pretreatment at the onset of dexmedetomidine infusion

Intervention Type DRUG

atropine 0.5mg

intravenous atropine 0.5mg pretreatment at the onset of dexmedetomidine infusion

Intervention Type DRUG

ephedrine 8mg

intravenous ephedrine 8mg pretreatment at the onset of dexmedetomidine infusion

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No