Remimazolam Bolus for General Anesthesia

Yonsei University Health System (YUHS)

Status and phase: Completed; Phase 3

Conditions: Loss of Consciousness

Treatments: Drug: 0.02 mg/kg, age<65; Drug: 0.02 mg/kg, age≥65; Drug: 0.22 mg/kg, age<65; Drug: 0.12 mg/kg, age<65; Drug: 0.17 mg/kg, age<65; Drug: 0.27 mg/kg, age<65; Drug: 0.27 mg/kg, age≥65; Drug: 0.17 mg/kg, age≥65; Drug: 0.07 mg/kg, age<65; Drug: 0.22 mg/kg, age≥65; Drug: 0.12 mg/kg, age≥65; Drug: 0.07 mg/kg, age≥65

Study type: Interventional

Funder types: Other

Identifiers

NCT04901871

3-2021-0091

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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120 participants in 12 patient groups

1 (0.02 mg/kg, age<65)

Active Comparator group

Description:

Remimazolam of 0.02 mg/kg will be infused in patients aged\<65.

Treatment:

Drug: 0.02 mg/kg, age<65

2 (0.07 mg/kg, age<65)

Active Comparator group

Description:

Remimazolam of 0.07 mg/kg will be infused in patients aged\<65.

Treatment:

Drug: 0.07 mg/kg, age<65

3 (0.12 mg/kg, age<65)

Active Comparator group

Description:

Remimazolam of 0.12 mg/kg will be infused in patients aged\<65.

Treatment:

Drug: 0.12 mg/kg, age<65

4 (0.17 mg/kg, age<65)

Active Comparator group

Description:

Remimazolam of 0.17 mg/kg will be infused in patients aged\<65.

Treatment:

Drug: 0.17 mg/kg, age<65

5(0.22 mg/kg, age<65)

Active Comparator group

Description:

Remimazolam of 0.22 mg/kg will be infused in patients aged\<65.

Treatment:

Drug: 0.22 mg/kg, age<65

6(0.27 mg/kg, age<65)

Active Comparator group

Description:

Remimazolam of 0.27 mg/kg will be infused in patients aged\<65.

Treatment:

Drug: 0.27 mg/kg, age<65

7 (0.02 mg/kg, age≥65)

Active Comparator group

Description:

Remimazolam of 0.02 mg/kg will be infused in patients aged≥65.

Treatment:

Drug: 0.02 mg/kg, age≥65

8 (0.07 mg/kg, age≥65)

Active Comparator group

Description:

Remimazolam of 0.07 mg/kg will be infused in patients aged≥65.

Treatment:

Drug: 0.07 mg/kg, age≥65

9 (0.12 mg/kg, age≥65)

Active Comparator group

Description:

Remimazolam of 0.12 mg/kg will be infused in patients aged≥65.

Treatment:

Drug: 0.12 mg/kg, age≥65

10 (0.17 mg/kg, age≥65)

Active Comparator group

Description:

Remimazolam of 0.17 mg/kg will be infused in patients aged≥65.

Treatment:

Drug: 0.17 mg/kg, age≥65

11 (0.22 mg/kg, age≥65)

Active Comparator group

Description:

Remimazolam of 0.22 mg/kg will be infused in patients aged≥65.

Treatment:

Drug: 0.22 mg/kg, age≥65

12 (0.27 mg/kg, age≥65)

Active Comparator group

Description:

Remimazolam of 0.27 mg/kg will be infused in patients aged≥65.

Treatment:

Drug: 0.27 mg/kg, age≥65