Atropine or Ephedrine Pretreatment for Preventing Bradycardia in Elderly Patients
Primary Purpose
Anesthesia, Spinal, Dexmedetomidine, Bradycardia
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
normal saline
atropine 0.5mg
ephedrine 8mg
Sponsored by
About this trial
This is an interventional prevention trial for Anesthesia, Spinal
Eligibility 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
Sites / Locations
- Ajou universitiy school of medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Control group
Atropine group
Ephedrine group
Arm Description
intravenous normal saline pretreatment
intravenous atropine 0.5mg pretreatment
intravenous ephedrine 8mg pretreatment
Outcomes
Primary Outcome Measures
The incidence of intervention for bradycardia
The number of treatment for bradycardia which is defined as heart rate under 50 beats per minute
Secondary Outcome Measures
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
Systolic/ mean/ diastolic blood pressure
Systolic/ mean/ diastolic blood pressure
Full Information
NCT ID
NCT03984526
First Posted
June 11, 2019
Last Updated
February 2, 2021
Sponsor
Ajou University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03984526
Brief Title
Atropine or Ephedrine Pretreatment for Preventing Bradycardia in Elderly Patients
Official Title
Comparison of Effect of Atropine or Ephedrine Pretreatment for Preventing Bradycardia Under Sedation With Dexmedetomidine After Spinal Anesthesia in Elderly Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 25, 2019 (Actual)
Primary Completion Date
September 15, 2020 (Actual)
Study Completion Date
September 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Spinal, Dexmedetomidine, Bradycardia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
intravenous normal saline pretreatment
Arm Title
Atropine group
Arm Type
Experimental
Arm Description
intravenous atropine 0.5mg pretreatment
Arm Title
Ephedrine group
Arm Type
Experimental
Arm Description
intravenous ephedrine 8mg pretreatment
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
intravenous normal saline pretreatment at the onset of dexmedetomidine infusion
Intervention Type
Drug
Intervention Name(s)
atropine 0.5mg
Intervention Description
intravenous atropine 0.5mg pretreatment at the onset of dexmedetomidine infusion
Intervention Type
Drug
Intervention Name(s)
ephedrine 8mg
Intervention Description
intravenous ephedrine 8mg pretreatment at the onset of dexmedetomidine infusion
Primary Outcome Measure Information:
Title
The incidence of intervention for bradycardia
Description
The number of treatment for bradycardia which is defined as heart rate under 50 beats per minute
Time Frame
for 1 hour after spinal anesthesia
Secondary Outcome Measure Information:
Title
The incidence of intervention for hypotension
Description
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
Time Frame
for 1 hour after spinal anesthesia
Title
Systolic/ mean/ diastolic blood pressure
Description
Systolic/ mean/ diastolic blood pressure
Time Frame
for 1 hour after spinal anesthesia
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yun jeong chae, Ph.D
Organizational Affiliation
Ajou University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ajou universitiy school of medicine
City
Suwon-si
State/Province
Gyeong-gi Do
ZIP/Postal Code
16499
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Atropine or Ephedrine Pretreatment for Preventing Bradycardia in Elderly Patients
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