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NCT03984526
Atropine or Ephedrine Pretreatment for Preventing Bradycardia in Elderly Patients
Phase 4 trial testing normal saline in Anesthesia, Spinal in 102 participants. Completed in 15 September 2020.
15 September 2020
Quick facts
| Lead sponsor | Ajou University School of Medicine |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 102 |
| Start date | 25 June 2019 |
| Primary completion | 15 September 2020 |
| Estimated completion | 15 September 2020 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- normal saline
- atropine 0.5mg — full drug profile →
- ephedrine 8mg — full drug profile →
Conditions studied
- Anesthesia, Spinal — all drugs for Anesthesia, Spinal →
- Dexmedetomidine — all drugs for Dexmedetomidine →
- Bradycardia — all drugs for Bradycardia →
Sponsor
Ajou University School of Medicine
Who can join
Adults 65 to 100, any sex, with Anesthesia, Spinal or Dexmedetomidine. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03984526
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Other Ajou University School of Medicine trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03984526 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ajou University School of Medicine
- Last refreshed: 4 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03984526.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing