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NCT05468996
Median Effective Dose of Remimazolam for Sedation in Elderly Patients
Phase 4 trial testing Remimazolam in Sedative in 60 participants. Completed in 28 October 2022.
28 October 2022
Quick facts
| Lead sponsor | Asan Medical Center |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 60 |
| Start date | 10 May 2022 |
| Primary completion | 28 October 2022 |
| Estimated completion | 28 October 2022 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Remimazolam — full drug profile →
Conditions studied
- Sedative — all drugs for Sedative →
Sponsor
Asan Medical Center
Who can join
20 and older, any sex, with Sedative. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Currently used drugs for monitored general anesthesia include propofol, midazolam, and dexmedetomidine. Each drug has different advantages and disadvantages. Remimazolam causes a relatively small decrease in blood pressure, and it has no injection pain. In addition, remimazolam has a very short onset time, and even after the continuous infusion, the onset of remimazolam is fast, and even after continuous injection, the effect disappeared very quickly due to the short context-sensitive half time. And through continuous infusion, the patient's depth of anesthesia can be maintained constant. In addition, the short duration of action and the ability to quickly reverse the effect of flumazenil suggest that remimazolam can be used effectively under general anesthesia as well as under general anesthesia. Remimazolam can be used as a continuous infusion for general anesthesia. However, it has also been reported to be used for sedation by continuous infusion or divided intravenous infusion. However, the effective maintenance dose of remimazolam for sedation without mechanical ventilation has not been established. In addition, age might be an important factor for determining the appropriate dose of remimazolam. In this study, we aim to identify the median effective dose of remimazolam for maintaining sedation in elderly patients undergoing lower limb surgery under 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 NCT05468996
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of Remimazolam
Trials testing the same drug.
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- NCT07459322 — The Use of Remimazolam Versus Dexmedetomidine for Patients Receiving Drug-Induced Sleep Endoscopy · NA · not yet recruiting
- NCT07290205 — Remimazolam NeuroImaging · EARLY_PHASE1 · recruiting
- NCT07269808 — Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration · Phase 3 · recruiting
- NCT06231563 — Ketamine for Veterans With Parkinson's Disease · Phase 2 · recruiting
Other Asan Medical Center trials
Trials by the same sponsor.
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- NCT07489092 — Feasibility of a Digital Rehabilitation Platform in Patients After ICU Discharge · NA · recruiting
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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 NCT05468996 (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 Asan Medical Center
- Last refreshed: 21 April 2023
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/NCT05468996.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing