Sedative
Conditions
Brief 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.
Interventions
DRUGRemimazolam
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
Asan Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age: equal or older than 20 years * ASA PS: 1-3 * patients who are scheduled to undergo lower limb surgery under spinal anesthesia with 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| success or failure of sedation maintenance | throughout the surgery | MOAA/S score of 3 or less (MOAA/S: Modified Observer's Alertness/Sedation scale) Awake (5) - Unresponsive (0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| respiratory depression | throughout the surgery | respiratory rate equal or less than 6 time per minute |
Countries
South Korea
Outcome results
None listed