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CompletedNCT04901871Updated Jul 28, 2021

Remimazolam Bolus for General Anesthesia

A Phase 3 interventional study of 0.02 mg/kg, age<65 and 0.07 mg/kg, age<65 in Loss of Consciousness, sponsored by Gangnam Severance Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2021-07-28.

Sponsored by Gangnam Severance Hospital · Phase 3, Interventional, and Other

Phase
Phase 3
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Loss of Consciousness

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03

In context

Unconsciousness

89 studies on the registry are indexed under Unconsciousness; 11 are open to participants now.

This study's enrollment of 120 is above the median of 51 across 56 interventional studies indexed under Unconsciousness.

Browse Unconsciousness studies →

Lead sponsor

Gangnam Severance Hospital is the lead sponsor of 141 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 3
Primary purpose
Other
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    1 (0.02 mg/kg, age<65)

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

    Drug: 0.02 mg/kg, age<65

  • Active comparator
    2 (0.07 mg/kg, age<65)

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

    Drug: 0.07 mg/kg, age<65

  • Active comparator
    3 (0.12 mg/kg, age<65)

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

    Drug: 0.12 mg/kg, age<65

  • Active comparator
    4 (0.17 mg/kg, age<65)

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

    Drug: 0.17 mg/kg, age<65

  • Active comparator
    5(0.22 mg/kg, age<65)

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

    Drug: 0.22 mg/kg, age<65

  • Active comparator
    6(0.27 mg/kg, age<65)

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

    Drug: 0.27 mg/kg, age<65

  • Active comparator
    7 (0.02 mg/kg, age≥65)

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

    Drug: 0.02 mg/kg, age≥65

  • Active comparator
    8 (0.07 mg/kg, age≥65)

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

    Drug: 0.07 mg/kg, age≥65

  • Active comparator
    9 (0.12 mg/kg, age≥65)

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

    Drug: 0.12 mg/kg, age≥65

  • Active comparator
    10 (0.17 mg/kg, age≥65)

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

    Drug: 0.17 mg/kg, age≥65

  • Active comparator
    11 (0.22 mg/kg, age≥65)

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

    Drug: 0.22 mg/kg, age≥65

  • Active comparator
    12 (0.27 mg/kg, age≥65)

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

    Drug: 0.27 mg/kg, age≥65

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.

06

What researchers measure

Primary outcomes

  1. Loss of consciousness within 5 minutes

    Loss of consciousness will be evaluated at 5 minutes after infusion.

    Time frame: At 5 minutes after infusion

Secondary outcomes

  1. Time to loss of consciousness

    Time to loss of consciousness will be assessed at 5 minutes after infusion.

    Time frame: At 5 minutes after infusion (time to loss of consciousness)

  2. blood pressure

    Blood pressure will be measured at 0, 1, 2, 3, 4, 5 minutes after infusion.

    Time frame: At 5 minutes after infusion

  3. heart rate

    Heart rate will be measured at 0, 1, 2, 3, 4, 5 minutes after infusion.

    Time frame: At 5 minutes after infusion

  4. sedline

    Sedline will be measured at 0, 1, 2, 3, 4, 5 minutes after infusion.

    Time frame: At 5 minutes after infusion

07

Study locations

1 site
  • Gangnam Severance Hospital
    Seoul, Korea, Republic of
08

References and documents

Publications

  • Chae D, Kim HC, Song Y, Choi YS, Han DW. Pharmacodynamic analysis of intravenous bolus remimazolam for loss of consciousness in patients undergoing general anaesthesia: a randomised, prospective, double-blind study. Br J Anaesth. 2022 Jul;129(1):49-57. doi: 10.1016/j.bja.2022.02.040. Epub 2022 May 11. Erratum In: Br J Anaesth. 2022 Nov;129(5):831. doi: 10.1016/j.bja.2022.08.010. PubMed 35562226 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04901871
Lead sponsor
Gangnam Severance Hospital
Responsible party
Dong Woo Han (Associate professor, Gangnam Severance Hospital) — Principal investigator
First posted
May 26, 2021
Start date
May 27, 2021
Primary completion
Jul 20, 2021
Completion
Jul 26, 2021
Last update
Jul 28, 2021

Study contacts

Dong Woo Han
principal investigator · GangnamSeveracne Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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