Atropine or Ephedrine Pretreatment for Preventing Bradycardia in Elderly Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Bradycardia; Dexmedetomidine; Anesthesia, Spinal
• Intervention / Treatment: Drug: normal saline; Drug: atropine 0.5mg; Drug: ephedrine 8mg

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeong-gi Do
    • Suwon-si, Gyeong-gi Do, Korea, Republic of, 16499
      • Ajou universitiy school of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 100 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; intravenous normal saline pretreatment	Drug: normal saline; intravenous normal saline pretreatment at the onset of dexmedetomidine infusion
Experimental: Atropine group; intravenous atropine 0.5mg pretreatment	Drug: atropine 0.5mg; intravenous atropine 0.5mg pretreatment at the onset of dexmedetomidine infusion
Experimental: Ephedrine group; intravenous ephedrine 8mg pretreatment	Drug: ephedrine 8mg; intravenous ephedrine 8mg pretreatment at the onset of dexmedetomidine infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Systolic/ mean/ diastolic blood pressure	Systolic/ mean/ diastolic blood pressure	for 1 hour after spinal anesthesia

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2019
• Primary Completion (Actual): September 15, 2020
• Study Completion (Actual): September 15, 2020

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (Actual): June 13, 2019

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Bradycardia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Central Nervous System Stimulants; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Atropine; Ephedrine
• Other Study ID Numbers: AJIRB-MED-THE-18-343

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No