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出境医 / 临床实验 / Atropine or Ephedrine Pretreatment for Preventing Bradycardia in Elderly Patients

Atropine or Ephedrine Pretreatment for Preventing Bradycardia in Elderly Patients

Study Description
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
Layout table for study information
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
Arms and Interventions
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
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
Layout table for eligibility information
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

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: yun jeong chae, Ph.D Ajou University School of Medicine
Tracking Information
First Submitted Date  ICMJE June 11, 2019
First Posted Date  ICMJE June 13, 2019
Last Update Posted Date February 4, 2021
Actual Study Start Date  ICMJE June 25, 2019
Actual Primary Completion Date September 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2020)
  • 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
  • Systolic/ mean/ diastolic blood pressure [ Time Frame: for 1 hour after spinal anesthesia ]
    Systolic/ mean/ diastolic blood pressure
Original Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • 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
  • Systolic/ mean/ diastolic blood pressure [ Time Frame: for 1 hour after spinal anesthesia ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Atropine or Ephedrine Pretreatment for Preventing Bradycardia in Elderly Patients
Official Title  ICMJE Comparison of Effect of Atropine or Ephedrine Pretreatment for Preventing Bradycardia Under Sedation With Dexmedetomidine After Spinal Anesthesia in Elderly Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Anesthesia, Spinal
  • Dexmedetomidine
  • Bradycardia
Intervention  ICMJE
  • Drug: normal saline
    intravenous normal saline pretreatment at the onset of dexmedetomidine infusion
  • Drug: atropine 0.5mg
    intravenous atropine 0.5mg pretreatment at the onset of dexmedetomidine infusion
  • Drug: ephedrine 8mg
    intravenous ephedrine 8mg pretreatment at the onset of dexmedetomidine infusion
Study Arms  ICMJE
  • Placebo Comparator: Control group
    intravenous normal saline pretreatment
    Intervention: Drug: normal saline
  • Experimental: Atropine group
    intravenous atropine 0.5mg pretreatment
    Intervention: Drug: atropine 0.5mg
  • Experimental: Ephedrine group
    intravenous ephedrine 8mg pretreatment
    Intervention: Drug: ephedrine 8mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 11, 2019) 		102
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 15, 2020
Actual Primary Completion Date September 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 100 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03984526
Other Study ID Numbers  ICMJE AJIRB-MED-THE-18-343
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party yun jeong chae, Ajou University School of Medicine
Study Sponsor  ICMJE Ajou University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: yun jeong chae, Ph.D Ajou University School of Medicine
PRS Account Ajou University School of Medicine
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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