Remimazolam Bolus for General Anesthesia

Loss of Consciousness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04901871
• Other study ID #: 3-2021-0091
• Status: Completed
• Phase: Phase 3
• Start date: May 27, 2021
• Est. completion date: July 26, 2021

Study information

• Verified date: July 2021
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 26, 2021
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Loss of Consciousness
• Unconsciousness

Intervention

Drug:
• 0.02 mg/kg, age<65
Remimazolam of 0.02 mg/kg will be infused in patients aged<65.
• 0.07 mg/kg, age<65
Remimazolam of 0.07 mg/kg will be infused in patients aged<65.
• 0.12 mg/kg, age<65
Remimazolam of 0.12 mg/kg will be infused in patients aged<65.
• 0.17 mg/kg, age<65
Remimazolam of 0.17 mg/kg will be infused in patients aged<65.
• 0.22 mg/kg, age<65
Remimazolam of 0.22 mg/kg will be infused in patients aged<65.
• 0.27 mg/kg, age<65
Remimazolam of 0.27 mg/kg will be infused in patients aged<65.
• 0.02 mg/kg, age=65
Remimazolam of 0.02 mg/kg will be infused in patients aged=65.
• 0.07 mg/kg, age=65
Remimazolam of 0.07 mg/kg will be infused in patients aged=65.
• 0.12 mg/kg, age=65
Remimazolam of 0.12 mg/kg will be infused in patients aged=65
• 0.17 mg/kg, age=65
Remimazolam of 0.17 mg/kg will be infused in patients aged=65.
• 0.22 mg/kg, age=65
Remimazolam of 0.22 mg/kg will be infused in patients aged=65.
• 0.27 mg/kg, age=65
Remimazolam of 0.27 mg/kg will be infused in patients aged=65.

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Loss of consciousness within 5 minutes	Loss of consciousness will be evaluated at 5 minutes after infusion.	At 5 minutes after infusion
Secondary	Time to loss of consciousness	Time to loss of consciousness will be assessed at 5 minutes after infusion.	At 5 minutes after infusion (time to loss of consciousness)
Secondary	blood pressure	Blood pressure will be measured at 0, 1, 2, 3, 4, 5 minutes after infusion.	At 5 minutes after infusion
Secondary	heart rate	Heart rate will be measured at 0, 1, 2, 3, 4, 5 minutes after infusion.	At 5 minutes after infusion
Secondary	sedline	Sedline will be measured at 0, 1, 2, 3, 4, 5 minutes after infusion.	At 5 minutes after infusion