Atropine or Ephedrine Pretreatment for Preventing Bradycardia in Elderly Patients
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ClinicalTrials.gov Identifier: NCT03984526 |
Recruitment Status :
Completed
First Posted : June 13, 2019
Last Update Posted : February 4, 2021
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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 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 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Control group
intravenous normal saline pretreatment
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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 |
- 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
- 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

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

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
Korea, Republic of | |
Ajou universitiy school of medicine | |
Suwon-si, Gyeong-gi Do, Korea, Republic of, 16499 |
Principal Investigator: | yun jeong chae, Ph.D | Ajou University School of Medicine |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |