Loss of Consciousness
Conditions
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.
Interventions
DRUG0.02 mg/kg, age<65
Remimazolam of 0.02 mg/kg will be infused in patients aged\<65.
DRUG0.07 mg/kg, age<65
Remimazolam of 0.07 mg/kg will be infused in patients aged\<65.
DRUG0.12 mg/kg, age<65
Remimazolam of 0.12 mg/kg will be infused in patients aged\<65.
DRUG0.17 mg/kg, age<65
Remimazolam of 0.17 mg/kg will be infused in patients aged\<65.
DRUG0.22 mg/kg, age<65
Remimazolam of 0.22 mg/kg will be infused in patients aged\<65.
DRUG0.27 mg/kg, age<65
Remimazolam of 0.27 mg/kg will be infused in patients aged\<65.
DRUG0.02 mg/kg, age≥65
Remimazolam of 0.02 mg/kg will be infused in patients aged≥65.
DRUG0.07 mg/kg, age≥65
Remimazolam of 0.07 mg/kg will be infused in patients aged≥65.
DRUG0.12 mg/kg, age≥65
Remimazolam of 0.12 mg/kg will be infused in patients aged≥65
DRUG0.17 mg/kg, age≥65
Remimazolam of 0.17 mg/kg will be infused in patients aged≥65.
DRUG0.22 mg/kg, age≥65
Remimazolam of 0.22 mg/kg will be infused in patients aged≥65.
DRUG0.27 mg/kg, age≥65
Remimazolam of 0.27 mg/kg will be infused in patients aged≥65.
Sponsors
Gangnam Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Loss of consciousness within 5 minutes | At 5 minutes after infusion | Loss of consciousness will be evaluated at 5 minutes after infusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| blood pressure | At 5 minutes after infusion | Blood pressure 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. |
| sedline | At 5 minutes after infusion | Sedline will be measured at 0, 1, 2, 3, 4, 5 minutes after infusion. |
Countries
South Korea
Outcome results
None listed