Trials Sponsors Conditions Drugs Pricing

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

Interventions

0.02 mg/kg, age<65Drug

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

1 (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.

2 (0.07 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:

Sponsors & Collaborators

Gangnam Severance Hospital
Otherlead

Study Sites (1)

Gangnam Severance Hospital

Seoul, South Korea

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

Enrollment

120 participants (actual enrollment reported by the registry).

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

Actual (reported)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (12)

1 (0.02 mg/kg, age<65)

2 (0.07 mg/kg, age<65)

3 (0.12 mg/kg, age<65)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

4 (0.17 mg/kg, age<65)

5(0.22 mg/kg, age<65)

6(0.27 mg/kg, age<65)

7 (0.02 mg/kg, age≥65)

8 (0.07 mg/kg, age≥65)

9 (0.12 mg/kg, age≥65)

10 (0.17 mg/kg, age≥65)

11 (0.22 mg/kg, age≥65)

12 (0.27 mg/kg, age≥65)

Source record

Locations