Median Effective Dose of Remimazolam for Sedation in Elderly Patients

Asan Medical Center

Status and phase: Completed; Phase 4

Conditions: Sedative

Treatments: Drug: Remimazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT05468996

2021-1869

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

---

60 participants in 3 patient groups

young-old group

Active Comparator group

Description:

a group of patients who are 60 to 74 years old

Treatment:

Drug: Remimazolam

old-old group

Active Comparator group

Description:

a group of patients who are equal or older than 75 years

Treatment:

Drug: Remimazolam

young adult group

Active Comparator group

Description:

a group of patients who are 20-59 years old

Treatment:

Drug: Remimazolam