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ED90 of Remimazolam Loading Dose for Sedation in Patients Under Monitored Anesthetic Care

A

Asan Medical Center

Status and phase

Completed
Phase 4

Conditions

Remimazolam
Orthopedic Procedures
Sedatives

Treatments

Drug: Remimazolam

Study type

Interventional

Funder types

Other

Identifiers

NCT05340335
S2021-2407-0002

Details and patient eligibility

About

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. nd 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 infusion dose of remimazolam for supervised general anesthesia without mechanical ventilation has not been established.

In this study, the ED90 of the loading dose to induce loss of consciousness in patients when supervised general anesthesia is performed through continuous infusion of Remimazolam is to be obtained.

Enrollment

50 patients

Sex

All

Ages

19 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ASA PS 1-3
  • Patients who are scheduled to undergo upper/lower limb surgery under the monitored anesthetic care with remimazolam

Exclusion criteria

  • Patients who refuse to participate in this study
  • Patients with hypersensitivity to benzodiazepine or flumazenil
  • Patients with severe renal/hepatic disease
  • Patients with drug/alcohol abuse
  • Patients who take antidepressants, anticonvulsants, psychoactive drugs chronically
  • Patients with difficulty in communication
  • Patients with severe obstructive sleep apnea or other airway problems
  • Patients contraindicated to regional anesthesia
  • Patients judged to be inappropriate for this study

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Remimazolam
Experimental group
Description:
A loading dose of remimazolam is administered for sedation
Treatment:
Drug: Remimazolam

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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