Median Effective Dose of Remimazolam for Sedation in Elderly Patients

NCT ID: NCT05468996

Last Updated: 2023-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-10
• Study Completion Date: 2022-10-28

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.

Conditions

Sedative

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

young-old group

a group of patients who are 60 to 74 years old

Group Type: ACTIVE_COMPARATOR

Remimazolam

Intervention Type: DRUG

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)

old-old group

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

Group Type: ACTIVE_COMPARATOR

Remimazolam

Intervention Type: DRUG

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)

young adult group

a group of patients who are 20-59 years old

Group Type: ACTIVE_COMPARATOR

Remimazolam

Intervention Type: DRUG

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)

Interventions

Remimazolam

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)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Won Uk, Koh

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Won Uk Koh

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2021-1869

Identifier Type: -

Identifier Source: org_study_id