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Median Effective Dose of Remimazolam for Sedation in Elderly Patients

NCT05468996 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-04-21

No results posted yet for this study

Summary

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.

Conditions

  • Sedative

Interventions

DRUG

Remimazolam

A loading dose of remimazolam is 1mg/kg/hr. When sedation is achieved, the dose of remimazolam is adjusted to the assigned dose. The maintenance dose of remimazolam begins at 1.0mg/kg/hr. When the maintenance is not successful during the surgery, the maintenance dose will be increased by 0.1-0.2mg/kg/hr in the next patient. When the maintenance is successful, the dose will be decreased by 0.1-0.2mg/kg/hr. (maximal dose: 2mg/kg/hr)

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Won Uk Koh · Asan Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-10
Primary Completion
2022-10-28
Completion
2022-10-28

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05468996 on ClinicalTrials.gov