Median Effective Dose of Remimazolam for Sedation in Elderly Patients

NCT05468996 | Completed Phase 4

• 1 other identifier: 2021-1869
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• success or failure of sedation maintenance

  MOAA/S score of 3 or less (MOAA/S: Modified Observer's Alertness/Sedation scale) Awake (5) - Unresponsive (0)

  throughout the surgery

Secondary Outcomes (1)

• respiratory depression

  throughout the surgery

Study Arms (3)

young-old group

ACTIVE COMPARATOR

a group of patients who are 60 to 74 years old

Drug: Remimazolam

old-old group

ACTIVE COMPARATOR

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

Drug: Remimazolam

young adult group

ACTIVE COMPARATOR

a group of patients who are 20-59 years old

Drug: Remimazolam

Interventions

Remimazolam 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; young adult group; young-old group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Interventions

remimazolam

Study Officials

• Won Uk Koh

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: July 21, 2022
• Study Start: May 10, 2022
• Primary Completion: October 28, 2022
• Study Completion: October 28, 2022
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

KR (1)