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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05379777
Other study ID # 2021-1638
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 11, 2022
Est. completion date August 24, 2022

Study information

Verified date December 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. 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 infusion dose of remimazolam for supervised general anesthesia without mechanical ventilation has not been established. In this study, the ED90 of the maintenance dose that maintain loss of consciousness in patients when supervised general anesthesia is performed through continuous infusion of remimazolam after spinal anesthesia is obtained.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date August 24, 2022
Est. primary completion date August 24, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years to 79 Years
Eligibility Inclusion Criteria: - ASA PS 1-3 - Patients undergoing lower extremity surgery under spinal anesthesia and sedation using 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


Intervention

Drug:
Remimazolam
Remimazolam The starting dose of remimazolam is 1 mg/kg/hr. If sedation does not proceed successfully, increase the infusion rate by 0.2 mg/kg/hr in the next patient. (However, if the infusion rate is less than 0.6mg/kg/hr, the dose is increased by 0.1mg/kg/hr.) If sedation has progressed successfully until the end of surgery, the next patient will use the same dose with a probability of 0.89 or 0.11 It is reduced by 0.2 mg/kg/hr with a probability of (However, if the infusion rate is 0.6mg/kg/hr or less, reduce it by 0.1mg/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 success or failure of sedation maintenace MOAA/S score of 3 or less (MOAA/S: Modified Observer's Alertness/Sedation scale) Awake (5) - Unresponsive (0) throughout the surgery
Secondary Frequency of respiratory depression respiratory rate equal or less than 6 time per minute throughout the surgery
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