Remimazolam Bolus for General Anesthesia

ED50 and ED95 of Remimazolam Intravenous Bolus on the Loss of Consciousness in Patients Undergoing General Anesthesia

It is important to estimate the adequate dose of remimazolam intravenous bolus injection to induce the loss of consciousness. We will determine the ED50 and ED95 of remimazolam intravenous bolus on the loss of consciousness in patients undergoing general anesthesia.

Study Overview

• Status: Completed
• Conditions: Loss of Consciousness
• Intervention / Treatment: Drug: 0.02 mg/kg, age<65; Drug: 0.07 mg/kg, age<65; Drug: 0.12 mg/kg, age<65; Drug: 0.17 mg/kg, age<65; Drug: 0.22 mg/kg, age<65; Drug: 0.27 mg/kg, age<65; Drug: 0.02 mg/kg, age≥65; Drug: 0.07 mg/kg, age≥65; Drug: 0.12 mg/kg, age≥65; Drug: 0.17 mg/kg, age≥65; Drug: 0.22 mg/kg, age≥65; Drug: 0.27 mg/kg, age≥65

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for general anesthesia

Exclusion Criteria:

1. Patients scheduled for liver surgery
2. Uncontrolled hypertension
3. Uncontrolled diabetes mellitus
4. Liver disease
5. Kidney disease
6. Intolerance or hypersensitivity to benzodiazepine
7. Addiction
8. Glaucoma
9. Heart failure
10. Peripheral vascular disease
11. Obstuctive lung disease
12. Patients scheduled for regional anesthesia before general anesthesia
13. Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1 (0.02 mg/kg, age<65); Remimazolam of 0.02 mg/kg will be infused in patients aged<65.	Drug: 0.02 mg/kg, age<65; Remimazolam of 0.02 mg/kg will be infused in patients aged<65.
Active Comparator: 2 (0.07 mg/kg, age<65); Remimazolam of 0.07 mg/kg will be infused in patients aged<65.	Drug: 0.07 mg/kg, age<65; Remimazolam of 0.07 mg/kg will be infused in patients aged<65.
Active Comparator: 3 (0.12 mg/kg, age<65); Remimazolam of 0.12 mg/kg will be infused in patients aged<65.	Drug: 0.12 mg/kg, age<65; Remimazolam of 0.12 mg/kg will be infused in patients aged<65.
Active Comparator: 4 (0.17 mg/kg, age<65); Remimazolam of 0.17 mg/kg will be infused in patients aged<65.	Drug: 0.17 mg/kg, age<65; Remimazolam of 0.17 mg/kg will be infused in patients aged<65.
Active Comparator: 5(0.22 mg/kg, age<65); Remimazolam of 0.22 mg/kg will be infused in patients aged<65.	Drug: 0.22 mg/kg, age<65; Remimazolam of 0.22 mg/kg will be infused in patients aged<65.
Active Comparator: 6(0.27 mg/kg, age<65); Remimazolam of 0.27 mg/kg will be infused in patients aged<65.	Drug: 0.27 mg/kg, age<65; Remimazolam of 0.27 mg/kg will be infused in patients aged<65.
Active Comparator: 7 (0.02 mg/kg, age≥65); Remimazolam of 0.02 mg/kg will be infused in patients aged≥65.	Drug: 0.02 mg/kg, age≥65; Remimazolam of 0.02 mg/kg will be infused in patients aged≥65.
Active Comparator: 8 (0.07 mg/kg, age≥65); Remimazolam of 0.07 mg/kg will be infused in patients aged≥65.	Drug: 0.07 mg/kg, age≥65; Remimazolam of 0.07 mg/kg will be infused in patients aged≥65.
Active Comparator: 9 (0.12 mg/kg, age≥65); Remimazolam of 0.12 mg/kg will be infused in patients aged≥65.	Drug: 0.12 mg/kg, age≥65; Remimazolam of 0.12 mg/kg will be infused in patients aged≥65
Active Comparator: 10 (0.17 mg/kg, age≥65); Remimazolam of 0.17 mg/kg will be infused in patients aged≥65.	Drug: 0.17 mg/kg, age≥65; Remimazolam of 0.17 mg/kg will be infused in patients aged≥65.
Active Comparator: 11 (0.22 mg/kg, age≥65); Remimazolam of 0.22 mg/kg will be infused in patients aged≥65.	Drug: 0.22 mg/kg, age≥65; Remimazolam of 0.22 mg/kg will be infused in patients aged≥65.
Active Comparator: 12 (0.27 mg/kg, age≥65); Remimazolam of 0.27 mg/kg will be infused in patients aged≥65.	Drug: 0.27 mg/kg, age≥65; Remimazolam of 0.27 mg/kg will be infused in patients aged≥65.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Loss of consciousness within 5 minutes	Loss of consciousness will be evaluated at 5 minutes after infusion.	At 5 minutes after infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to loss of consciousness	Time to loss of consciousness will be assessed at 5 minutes after infusion.	At 5 minutes after infusion (time to loss of consciousness)
blood pressure	Blood pressure will be measured at 0, 1, 2, 3, 4, 5 minutes after infusion.	At 5 minutes after infusion
heart rate	Heart rate will be measured at 0, 1, 2, 3, 4, 5 minutes after infusion.	At 5 minutes after infusion
sedline	Sedline will be measured at 0, 1, 2, 3, 4, 5 minutes after infusion.	At 5 minutes after infusion

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital
• Investigators: Principal Investigator: Dong Woo Han, GangnamSeveracne Hospital

Publications and helpful links

General Publications

• Chae D, Kim HC, Song Y, Choi YS, Han DW. Pharmacodynamic analysis of intravenous bolus remimazolam for loss of consciousness in patients undergoing general anaesthesia: a randomised, prospective, double-blind study. Br J Anaesth. 2022 Jul;129(1):49-57. doi: 10.1016/j.bja.2022.02.040. Epub 2022 May 11. Erratum In: Br J Anaesth. 2022 Nov;129(5):831.

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2021
• Primary Completion (Actual): July 20, 2021
• Study Completion (Actual): July 26, 2021

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 24, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Consciousness Disorders; Unconsciousness
• Other Study ID Numbers: 3-2021-0091

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No