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

Study Overview
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Brief Summary
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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.

Official Title
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Determination of the Effective Dose 90 of Remimazolam Loading Dose for Adequate Sedation in Patients Undergoing Orthopaedic Surgery Under Monitored Anesthetic Care

Conditions
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Remimazolam, Orthopedic Procedures, Sedatives

Intervention / Treatment
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* Drug: Remimazolam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remimazolam<br>A loading dose of remimazolam is administered for sedation | Drug: Remimazolam<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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remimazolam, sedative effect