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Remimazolam Bolus for General Anesthesia

NCT ID: NCT04901871

Last Updated: 2021-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-27

Study Completion Date

2021-07-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Loss of Consciousness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1 (0.02 mg/kg, age<65)

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

Group Type ACTIVE_COMPARATOR

0.02 mg/kg, age<65

Intervention Type DRUG

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

2 (0.07 mg/kg, age<65)

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

Group Type ACTIVE_COMPARATOR

0.07 mg/kg, age<65

Intervention Type DRUG

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

3 (0.12 mg/kg, age<65)

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

Group Type ACTIVE_COMPARATOR

0.12 mg/kg, age<65

Intervention Type DRUG

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

4 (0.17 mg/kg, age<65)

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

Group Type ACTIVE_COMPARATOR

0.17 mg/kg, age<65

Intervention Type DRUG

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

5(0.22 mg/kg, age<65)

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

Group Type ACTIVE_COMPARATOR

0.22 mg/kg, age<65

Intervention Type DRUG

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

6(0.27 mg/kg, age<65)

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

Group Type ACTIVE_COMPARATOR

0.27 mg/kg, age<65

Intervention Type DRUG

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

7 (0.02 mg/kg, age≥65)

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

Group Type ACTIVE_COMPARATOR

0.02 mg/kg, age≥65

Intervention Type DRUG

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

8 (0.07 mg/kg, age≥65)

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

Group Type ACTIVE_COMPARATOR

0.07 mg/kg, age≥65

Intervention Type DRUG

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

9 (0.12 mg/kg, age≥65)

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

Group Type ACTIVE_COMPARATOR

0.12 mg/kg, age≥65

Intervention Type DRUG

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

10 (0.17 mg/kg, age≥65)

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

Group Type ACTIVE_COMPARATOR

0.17 mg/kg, age≥65

Intervention Type DRUG

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

11 (0.22 mg/kg, age≥65)

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

Group Type ACTIVE_COMPARATOR

0.22 mg/kg, age≥65

Intervention Type DRUG

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

12 (0.27 mg/kg, age≥65)

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

Group Type ACTIVE_COMPARATOR

0.27 mg/kg, age≥65

Intervention Type DRUG

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

Interventions

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0.02 mg/kg, age<65

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

Intervention Type DRUG

0.07 mg/kg, age<65

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

Intervention Type DRUG

0.12 mg/kg, age<65

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

Intervention Type DRUG

0.17 mg/kg, age<65

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

Intervention Type DRUG

0.22 mg/kg, age<65

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

Intervention Type DRUG

0.27 mg/kg, age<65

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

Intervention Type DRUG

0.02 mg/kg, age≥65

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

Intervention Type DRUG

0.07 mg/kg, age≥65

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

Intervention Type DRUG

0.12 mg/kg, age≥65

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

Intervention Type DRUG

0.17 mg/kg, age≥65

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

Intervention Type DRUG

0.22 mg/kg, age≥65

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

Intervention Type DRUG

0.27 mg/kg, age≥65

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dong Woo Han

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dong Woo Han

Role: PRINCIPAL_INVESTIGATOR

GangnamSeveracne Hospital

Locations

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Gangnam Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 35562226 (View on PubMed)

Other Identifiers

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3-2021-0091

Identifier Type: -

Identifier Source: org_study_id

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