NCT04901871

Remimazolam Bolus for General Anesthesia

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Gangnam Severance Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-05-27
• Primary completion: 2021-07-20
• Completion: 2021-07-26
• First posted: 2021-05-26
• Last updated: 2021-07-28

Locations

1 site across 1 country: South Korea