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Atropine or Ephedrine Pretreatment for Preventing Bradycardia in Elderly Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03984526
Recruitment Status : Completed
First Posted : June 13, 2019
Last Update Posted : February 4, 2021
Sponsor:
Information provided by (Responsible Party):
yun jeong chae, Ajou University School of Medicine

Study Description
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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.


Condition or disease Intervention/treatment Phase
Anesthesia, Spinal Dexmedetomidine Bradycardia Drug: normal saline Drug: atropine 0.5mg Drug: ephedrine 8mg Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Comparison of Effect of Atropine or Ephedrine Pretreatment for Preventing Bradycardia Under Sedation With Dexmedetomidine After Spinal Anesthesia in Elderly Patients
Actual Study Start Date : June 25, 2019
Actual Primary Completion Date : September 15, 2020
Actual Study Completion Date : September 15, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. The incidence of intervention for bradycardia [ Time Frame: 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 :
  1. The incidence of intervention for hypotension [ Time Frame: 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

  2. Systolic/ mean/ diastolic blood pressure [ Time Frame: for 1 hour after spinal anesthesia ]
    Systolic/ mean/ diastolic blood pressure


Eligibility Criteria
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Ages Eligible for Study:   65 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984526


Locations
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Korea, Republic of
Ajou universitiy school of medicine
Suwon-si, Gyeong-gi Do, Korea, Republic of, 16499
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
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Principal Investigator: yun jeong chae, Ph.D Ajou University School of Medicine
More Information
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Responsible Party: yun jeong chae, Principal Investigator, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT03984526    
Other Study ID Numbers: AJIRB-MED-THE-18-343
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Atropine
Ephedrine
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Sympathomimetics
Vasoconstrictor Agents
Adrenergic Agents