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NCT02522858
Anticholinergic Premedication for Sedation With Dexmedetomidine During Spinal Anesthesia
Phase 4 trial testing Atropine in Bradycardia in 120 participants. Completed in 1 January 2016.
1 January 2016
Quick facts
| Lead sponsor | Sira Bang |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 120 |
| Start date | 1 August 2015 |
| Primary completion | 1 January 2016 |
| Estimated completion | 1 January 2016 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Atropine (ATROPINE) — full drug profile →
- Dexmedetomidine (dexmedetomidine) — full drug profile →
- Ephedrine (EPHEDRINE) — full drug profile →
Conditions studied
- Bradycardia — all drugs for Bradycardia →
Sponsor
Sira Bang
Who can join
20 and older, any sex, with Bradycardia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
The incidence of bradycardia
Time frame: 30miniutes from starting dexmedetomidine with loading dose
The heart rate decreasing 30% from initial heart rate or under 40/min would be regarded as bradycardia needing treatment, and atropine 0.5mg will be injected intravenously.
Sponsor's own description
Dexmedetomidine is a selective α2 adrenergic receptor antagonist, which has little effect on respiratory suppression used as sedative agent. Also, dexmedetomidine has been reported to prolong the anesthesia time when used with patients undergoing spinal anesthesia. However, dexmedetomidine has sympathetic effect which can cause hypotension and bradycardia dose dependently. Therefore, this study is aimed to evaluate the effectiveness of premedication of anticholinergic agents on vital sign in 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 NCT02522858
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Atropine
Trials testing the same drug.
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- NCT05815784 — Myopia Control: a Comparison Study Between Atropine and MiSight · Phase 2 · recruiting
- NCT06111352 — Outcome of Moderate Severity in OPC Poisoning Patients When Treated With Pralidoxime · Phase 2 · completed
- NCT05203432 — Red Light Intervention on Myopic Progression · NA · unknown
- NCT04699357 — The Effect and Safety of Different Doses of Atropine on Myopic Progression of Highly Myopic Children: Multi-centered Ran · NA · completed
Other recruiting trials for Bradycardia
Currently open trials in the same condition.
- NCT07209852 — Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up · recruiting
- NCT07254013 — Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution · NA · recruiting
- NCT07166614 — Dexmedetomidine vs Propofol in High-Risk ERCP Patients · NA · recruiting
- NCT07585799 — Permanent Conduction System Pacing Versus Atrioventricular Management for Patients With Wide QRS and Patent AV Conductio · NA · recruiting
- NCT07217392 — Left Bundle Branch Area Pacing (LBBAP) PMCF Study · NA · recruiting
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 NCT02522858 (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 Sira Bang
- Last refreshed: 14 January 2016
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/NCT02522858.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing