Anesthesia, SpinalPhase 4NCT03984526
Atropine or Ephedrine Pretreatment for Preventing Bradycardia in Elderly Patients
A Phase 4 study testing normal saline, atropine 0.5mg and ephedrine 8mg in people with Anesthesia, Spinal and Dexmedetomidine, run by Ajou University School of Medicine at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Anesthesia, Spinal, Dexmedetomidine, Bradycardia
- What is being tested?
- normal saline, atropine 0.5mg and ephedrine 8mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Jun 2019to 15 Sep 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) classification I-II
- Undergoing orthopedic surgery under spinal anesthesia
Who cannot join
- Contraindication for spinal anesthesia
- Atrial fibrillation, atrial flutter
- Cardiac valve disease
- Neurologic disease
- initial systolic blood pressure in operating room > 160mmHg
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Ajou universitiy school of medicine
Suwon, Gyeong-gi Do, 16499
About this study
Official title: Comparison of Effect of Atropine or Ephedrine Pretreatment for Preventing Bradycardia Under Sedation With Dexmedetomidine After Spinal Anesthesia in Elderly Patients
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.
- Conditions
- Anesthesia, Spinal, Dexmedetomidine, Bradycardia
- Being tested
- normal saline, atropine 0.5mg, ephedrine 8mg
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal salineDrug
intravenous normal saline pretreatment at the onset of dexmedetomidine infusion
atropine 0.5mgDrug
intravenous atropine 0.5mg pretreatment at the onset of dexmedetomidine infusion
ephedrine 8mgDrug
intravenous ephedrine 8mg pretreatment at the onset of dexmedetomidine infusion
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | intravenous normal saline pretreatment Receives: Drug: normal saline |
| Atropine group | Experimental | intravenous atropine 0.5mg pretreatment Receives: Drug: atropine 0.5mg |
| Ephedrine group | Experimental | intravenous ephedrine 8mg pretreatment Receives: Drug: ephedrine 8mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of intervention for bradycardia
The number of treatment for bradycardia which is defined as heart rate under 50 beats per minute
Measured: for 1 hour after spinal anesthesia
Secondary outcomes (2)
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
Measured: for 1 hour after spinal anesthesia
Systolic/ mean/ diastolic blood pressure
Systolic/ mean/ diastolic blood pressure
Measured: for 1 hour after spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start25 Jun 2019
- Primary completion15 Sep 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, SpinalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yun jeong chae, Ajou University School of Medicine
- Investigators
- yun jeong chae, Ph.D, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984526
- Sponsor's protocol ID
- AJIRB-MED-THE-18-343
- Status last verified
- Feb 2021
- First submitted
- 11 Jun 2019
- Last updated
- 4 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effect of Atropine or Ephedrine Pretreatment for Preventing Bradycardia Under Sedation With Dexmedetomidine After Spinal Anesthesia in Elderly Patients
- ClinicalTrials.gov ID
- NCT03984526
- Acronym / sponsor ID
- AJIRB-MED-THE-18-343
- Conditions
- Anesthesia, Spinal, Dexmedetomidine, Bradycardia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: normal salineintravenous normal saline pretreatment |
| Atropine group | Experimental | Drug: atropine 0.5mgintravenous atropine 0.5mg pretreatment |
| Ephedrine group | Experimental | Drug: ephedrine 8mgintravenous ephedrine 8mg pretreatment |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) classification I-II
- Undergoing orthopedic surgery under spinal anesthesia
Key exclusion criteria (5 listed)
- Contraindication for spinal anesthesia
- Atrial fibrillation, atrial flutter
- Cardiac valve disease
- Neurologic disease
- initial systolic blood pressure in operating room > 160mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| normal salineintravenous normal saline pretreatment at the onset of dexmedetomidine infusion | Drug | Control group |
| atropine 0.5mgintravenous atropine 0.5mg pretreatment at the onset of dexmedetomidine infusion | Drug | Atropine group |
| ephedrine 8mgintravenous ephedrine 8mg pretreatment at the onset of dexmedetomidine infusion | Drug | Ephedrine group |
Primary outcome
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
2 secondary outcomes
The incidence of intervention for hypotension
Time frame: for 1 hour after spinal anesthesia
Systolic/ mean/ diastolic blood pressure
Time frame: for 1 hour after spinal anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yun jeong chae, Ph.D principal investigator
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing normal saline, atropine 0.5mg and ephedrine 8mg in people with Anesthesia, Spinal and Dexmedetomidine, run by Ajou University School of Medicine at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of intervention for bradycardia (time frame: for 1 hour after spinal anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.