Remimazolam Bolus for General Anesthesia

Phase 3

Completed

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

• Registration Number: NCT04901871
• Lead Sponsor: Gangnam Severance Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-10
• Study First Submitted QC: 2021-05-24
• Study First Posted: 2021-05-26
• Study Start: 2021-05-27
• Status Verified: 2021-07
• Primary Completion: 2021-07-20
• Study Completion: 2021-07-26
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1 (0.02 mg/kg, age<65)	0.02 mg/kg, age<65	Remimazolam of 0.02 mg/kg will be infused in patients aged\<65.
4 (0.17 mg/kg, age<65)	0.17 mg/kg, age<65	Remimazolam of 0.17 mg/kg will be infused in patients aged\<65.
8 (0.07 mg/kg, age≥65)	0.07 mg/kg, age≥65	Remimazolam of 0.07 mg/kg will be infused in patients aged≥65.
6(0.27 mg/kg, age<65)	0.27 mg/kg, age<65	Remimazolam of 0.27 mg/kg will be infused in patients aged\<65.
2 (0.07 mg/kg, age<65)	0.07 mg/kg, age<65	Remimazolam of 0.07 mg/kg will be infused in patients aged\<65.
9 (0.12 mg/kg, age≥65)	0.12 mg/kg, age≥65	Remimazolam of 0.12 mg/kg will be infused in patients aged≥65.
3 (0.12 mg/kg, age<65)	0.12 mg/kg, age<65	Remimazolam of 0.12 mg/kg will be infused in patients aged\<65.
12 (0.27 mg/kg, age≥65)	0.27 mg/kg, age≥65	Remimazolam of 0.27 mg/kg will be infused in patients aged≥65.
5(0.22 mg/kg, age<65)	0.22 mg/kg, age<65	Remimazolam of 0.22 mg/kg will be infused in patients aged\<65.
7 (0.02 mg/kg, age≥65)	0.02 mg/kg, age≥65	Remimazolam of 0.02 mg/kg will be infused in patients aged≥65.
10 (0.17 mg/kg, age≥65)	0.17 mg/kg, age≥65	Remimazolam of 0.17 mg/kg will be infused in patients aged≥65.
11 (0.22 mg/kg, age≥65)	0.22 mg/kg, age≥65	Remimazolam of 0.22 mg/kg will be infused in patients aged≥65.

Primary Outcome Measures

Name	Time	Method
Loss of consciousness within 5 minutes	At 5 minutes after infusion	Loss of consciousness will be evaluated at 5 minutes after infusion.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of