Atropine or Ephedrine Pretreatment for Preventing Bradycardia in Elderly Patients

NCT03984526 | Completed Phase 4

• 1 other identifier: AJIRB-MED-THE-18-343
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, Spinal; Dexmedetomidine; Bradycardia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The incidence of intervention for hypotension

  for 1 hour after spinal anesthesia

• Systolic/ mean/ diastolic blood pressure

  for 1 hour after spinal anesthesia

Study Arms (3)

Control group

PLACEBO COMPARATOR

intravenous normal saline pretreatment

Drug: normal saline

Atropine group

EXPERIMENTAL

intravenous atropine 0.5mg pretreatment

Drug: atropine 0.5mg

Ephedrine group

EXPERIMENTAL

intravenous ephedrine 8mg pretreatment

Drug: ephedrine 8mg

Interventions

normal saline DRUG

intravenous normal saline pretreatment at the onset of dexmedetomidine infusion

Control group

atropine 0.5mg DRUG

intravenous atropine 0.5mg pretreatment at the onset of dexmedetomidine infusion

Atropine group

ephedrine 8mg DRUG

intravenous ephedrine 8mg pretreatment at the onset of dexmedetomidine infusion

Ephedrine group

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou universitiy school of medicine

Suwon, Gyeong-gi Do, 16499, South Korea

Location

MeSH Terms

Conditions

Bradycardia

Interventions

Saline Solution; Atropine; Ephedrine

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Phenethylamines; Ethylamines

Study Officials

• yun jeong chae, Ph.D

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 13, 2019
• Study Start: June 25, 2019
• Primary Completion: September 15, 2020
• Study Completion: September 15, 2020
• Last Updated: February 4, 2021

Record last verified: 2021-02

Locations

KR (1)