ED90 of Remimazolam Loading Dose for Sedation in Patients Under Monitored Anesthetic Care

NCT05340335 | Completed Phase 4

• 1 other identifier: S2021-2407-0002
• Study Type: interventional
• Target: 50
• 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. nd 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 loading dose to induce loss of consciousness in patients when supervised general anesthesia is performed through continuous infusion of Remimazolam is to be obtained.

Conditions

Remimazolam; Orthopedic Procedures; Sedatives

Keywords

remimazolam, sedative effect

Outcome Measures

Primary Outcomes (1)

• Whether sedation was successful

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

  for 10 minutes from the initiation of the remimazolam administration

Secondary Outcomes (2)

• Total amount of remimazolam for sedation

  From the initiation of the remimazolam administration to the time when MOAA/S score of 3 or less, assessed up to 10 minutes

• Effect site concentration

  From the initiation of the remimazolam administration to the time when MOAA/S score of 3 or less, assessed up to 10 minutes

Study Arms (1)

Remimazolam

EXPERIMENTAL

A loading dose of remimazolam is administered for sedation

Drug: Remimazolam

Interventions

Remimazolam DRUG

A beginning dose of remimazolam is 1mg/kg/hr. When sedation is not achieved in 10 minutes, the dose will be increased by 0.1mg/kg/hr in the next patient. When sedation is successful, the same dose will be used with the probability of 0.89, or the dose will be decreased by 0.1mg/kg/hr with the probability of 0.11 in the next patient. (maximal dose: 2mg/kg/hr)

Remimazolam

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA PS 1-3
• Patients who are scheduled to undergo upper/lower limb surgery under the monitored anesthetic care with 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

Related Publications (1)

• Kim HJ, Kim H, Park HS, Kim HJ, Ro YJ, Koh WU. Effective remimazolam loading dose for adequate sedation in regional anesthesia. Can J Anaesth. 2024 Jun;71(6):818-825. doi: 10.1007/s12630-024-02698-1. Epub 2024 Feb 20.

  PMID: 38378937 DERIVED

MeSH Terms

Interventions

remimazolam

Study Officials

• Ha-Jung Kim

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 22, 2022
• Study Start: April 18, 2022
• Primary Completion: May 2, 2022
• Study Completion: May 2, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-07

Locations

KR (1)