NCT04901871

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2021

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 26, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

May 27, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2021

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2021

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

2 months

First QC Date

May 10, 2021

Last Update Submit

July 26, 2021

Conditions

Loss of Consciousness

Outcome Measures

Primary Outcomes (1)

  • Loss of consciousness within 5 minutes

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

    At 5 minutes after infusion

Secondary Outcomes (4)

  • Time to loss of consciousness

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

  • blood pressure

    At 5 minutes after infusion

  • heart rate

    At 5 minutes after infusion

  • sedline

    At 5 minutes after infusion

Study Arms (12)

1 (0.02 mg/kg, age<65)

ACTIVE COMPARATOR

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

Drug: 0.02 mg/kg, age<65

2 (0.07 mg/kg, age<65)

ACTIVE COMPARATOR

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

Drug: 0.07 mg/kg, age<65

3 (0.12 mg/kg, age<65)

ACTIVE COMPARATOR

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

Drug: 0.12 mg/kg, age<65

4 (0.17 mg/kg, age<65)

ACTIVE COMPARATOR

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

Drug: 0.17 mg/kg, age<65

5(0.22 mg/kg, age<65)

ACTIVE COMPARATOR

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

Drug: 0.22 mg/kg, age<65

6(0.27 mg/kg, age<65)

ACTIVE COMPARATOR

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

Drug: 0.27 mg/kg, age<65

7 (0.02 mg/kg, age≥65)

ACTIVE COMPARATOR

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

Drug: 0.02 mg/kg, age≥65

8 (0.07 mg/kg, age≥65)

ACTIVE COMPARATOR

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

Drug: 0.07 mg/kg, age≥65

9 (0.12 mg/kg, age≥65)

ACTIVE COMPARATOR

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

Drug: 0.12 mg/kg, age≥65

10 (0.17 mg/kg, age≥65)

ACTIVE COMPARATOR

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

Drug: 0.17 mg/kg, age≥65

11 (0.22 mg/kg, age≥65)

ACTIVE COMPARATOR

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

Drug: 0.22 mg/kg, age≥65

12 (0.27 mg/kg, age≥65)

ACTIVE COMPARATOR

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

Drug: 0.27 mg/kg, age≥65

Interventions

0.02 mg/kg, age≥65DRUG

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

7 (0.02 mg/kg, age≥65)
0.07 mg/kg, age≥65DRUG

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

8 (0.07 mg/kg, age≥65)
0.12 mg/kg, age≥65DRUG

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

9 (0.12 mg/kg, age≥65)
0.17 mg/kg, age≥65DRUG

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

10 (0.17 mg/kg, age≥65)
0.22 mg/kg, age≥65DRUG

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

11 (0.22 mg/kg, age≥65)
0.27 mg/kg, age≥65DRUG

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

12 (0.27 mg/kg, age≥65)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for general anesthesia

You may not qualify if:

  • Patients scheduled for liver surgery
  • Uncontrolled hypertension
  • Uncontrolled diabetes mellitus
  • Liver disease
  • Kidney disease
  • Intolerance or hypersensitivity to benzodiazepine
  • Addiction
  • Glaucoma
  • Heart failure
  • Peripheral vascular disease
  • Obstuctive lung disease
  • Patients scheduled for regional anesthesia before general anesthesia
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam Severance Hospital

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 35562226DERIVED

MeSH Terms

Conditions

Unconsciousness

Condition Hierarchy (Ancestors)

Consciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dong Woo Han

    GangnamSeveracne Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 10, 2021

First Posted

May 26, 2021

Study Start

May 27, 2021

Primary Completion

July 20, 2021

Study Completion

July 26, 2021

Last Updated

July 28, 2021

Record last verified: 2021-07

Locations

KR(1)