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

Determination of the Effective Dose 90 of Remimazolam Loading Dose for Adequate Sedation in Patients Undergoing Orthopaedic Surgery Under Monitored Anesthetic Care

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.

Study Overview

• Status: Completed
• Conditions: Orthopedic Procedures; Remimazolam; Sedatives
• Intervention / Treatment: Drug: Remimazolam

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Remimazolam; A loading dose of remimazolam is administered for sedation	Drug: Remimazolam; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total amount of remimazolam for sedation	MOAA/S score of 3 or less	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	Calculated by a computerized program(Asanpump)	From the initiation of the remimazolam administration to the time when MOAA/S score of 3 or less, assessed up to 10 minutes

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: Ha-Jung Kim, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 18, 2022
• Primary Completion (ACTUAL): May 2, 2022
• Study Completion (ACTUAL): May 2, 2022

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (ACTUAL): April 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: remimazolam, sedative effect
• Other Study ID Numbers: S2021-2407-0002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No