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Atropine or Ephedrine Pretreatment for Preventing Bradycardia in Elderly Patients

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ClinicalTrials.gov Identifier: NCT03984526
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : June 18, 2019
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 0.6mg Drug: ephedrine 12mg Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 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 0.6mg pretreatment
 Drug: atropine 0.6mg
intravenous atropine 0.6mg pretreatment at the onset of dexmedetomidine infusion
Experimental: Ephedrine group
intravenous ephedrine 12mg pretreatment
 Drug: ephedrine 12mg
intravenous ephedrine 12mg 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 ]

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
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


Contacts
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Contact: yun jeong chae, Ph.D 82-10-8721-7444 yjchae06@hotmail.com

Locations
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Korea, Republic of
Ajou universitiy school of medicine Not yet recruiting
Suwon-si, Gyeong-gi Do, Korea, Republic of, 16499
Contact: yun jeong chae, Ph.D    82-10-8721-7444    yjchae06@hotmail.com   
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     History of Changes
Other Study ID Numbers: AJIRB-MED-THE-18-343
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019

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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
Dexmedetomidine
Ephedrine
Atropine
Pseudoephedrine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics