Remimazolam Bolus for General Anesthesia

Summary

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.

Conditions

• Loss of Consciousness

Interventions

DRUG

0.02 mg/kg, age<65

Remimazolam of 0.02 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.

DRUG

0.12 mg/kg, age<65

Remimazolam of 0.12 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.

DRUG

0.22 mg/kg, age<65

Remimazolam of 0.22 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.

DRUG

0.02 mg/kg, age≥65

Remimazolam of 0.02 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.

DRUG

0.12 mg/kg, age≥65

Remimazolam of 0.12 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.

DRUG

0.22 mg/kg, age≥65

Remimazolam of 0.22 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.

Sponsors & Collaborators

• Gangnam Severance Hospital

  lead OTHER

Principal Investigators

• Dong Woo Han · GangnamSeveracne Hospital

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-27

Primary Completion

2021-07-20

Completion

2021-07-26

Countries

• South Korea

Study Locations