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NCT05468996

Median Effective Dose of Remimazolam for Sedation in Elderly Patients

Completed Phase 4 Last updated 21 April 2023
What this trial tests

Phase 4 trial testing Remimazolam in Sedative in 60 participants. Completed in 28 October 2022.

Timeline
10 May 2022
Primary endpoint
28 October 2022
28 October 2022

Quick facts

Lead sponsorAsan Medical Center
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingsingle
Primary purposesupportive care
Enrollment60
Start date10 May 2022
Primary completion28 October 2022
Estimated completion28 October 2022
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

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.

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Other trials of Remimazolam

Trials testing the same drug.

Other Asan Medical Center trials

Trials by the same sponsor.

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Data sources for this page

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