NCT05379777

Effective Dose of Remimazolam for Sedation in Patients Undergoing Lower Extremity Surgery Under Spinal Anesthesia

Determination of Effective Dose 90 of Remimazolam That Can Maintain Loos of Consciousness From Sedation With Remimazolam in Adult Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 19 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Remimazolam
• Orthopedic Procedures
• Sedatives
• Anesthesia, Spinal

Interventions

Type	Name	Description
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.)

Timeline

• Start date: 2022-05-11
• Primary completion: 2022-08-24
• Completion: 2022-08-24
• First posted: 2022-05-18
• Last updated: 2022-12-19

Locations

1 site across 1 country: South Korea