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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05340335
Other study ID # S2021-2407-0002
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 18, 2022
Est. completion date May 2, 2022

Study information

Verified date July 2022
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date May 2, 2022
Est. primary completion date May 2, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Remimazolam
A beginning dose of remimazolam is 1mg/kg/hr. When sedation is not achieved in 10 minutes, the dose will be increased by 0.1mg/kg/hr in the next patient. When sedation is successful, the same dose will be used with the probability of 0.89, or the dose will be decreased by 0.1mg/kg/hr with the probability of 0.11 in the next patient. (maximal dose: 2mg/kg/hr)

Locations

Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Whether sedation was successful MOAA/S score of 3 or less (MOAA/S: Modified Observer's Alertness/Sedation scale) Awake (5) - Unresponsive (0) for 10 minutes from the initiation of the remimazolam administration
Secondary Total amount of remimazolam for sedation MOAA/S score of 3 or less From the initiation of the remimazolam administration to the time when MOAA/S score of 3 or less, assessed up to 10 minutes
Secondary Effect site concentration Calculated by a computerized program(Asanpump) From the initiation of the remimazolam administration to the time when MOAA/S score of 3 or less, assessed up to 10 minutes
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