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Remimazolam Bolus for General Anesthesia

Primary Purpose

Loss of Consciousness

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
0.02 mg/kg, age<65
0.07 mg/kg, age<65
0.12 mg/kg, age<65
0.17 mg/kg, age<65
0.22 mg/kg, age<65
0.27 mg/kg, age<65
0.02 mg/kg, age≥65
0.07 mg/kg, age≥65
0.12 mg/kg, age≥65
0.17 mg/kg, age≥65
0.22 mg/kg, age≥65
0.27 mg/kg, age≥65
Sponsored by
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Loss of Consciousness

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gangnam Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1 (0.02 mg/kg, age<65)

2 (0.07 mg/kg, age<65)

3 (0.12 mg/kg, age<65)

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)

Arm Description

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

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

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

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

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to loss of consciousness
Time to loss of consciousness will be assessed at 5 minutes after infusion.
blood pressure
Blood pressure will be measured at 0, 1, 2, 3, 4, 5 minutes after infusion.
heart rate
Heart rate will be measured at 0, 1, 2, 3, 4, 5 minutes after infusion.
sedline
Sedline will be measured at 0, 1, 2, 3, 4, 5 minutes after infusion.

Full Information

First Posted
May 10, 2021
Last Updated
July 26, 2021
Sponsor
Gangnam Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04901871
Brief Title
Remimazolam Bolus for General Anesthesia
Official Title
ED50 and ED95 of Remimazolam Intravenous Bolus on the Loss of Consciousness in Patients Undergoing General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 27, 2021 (Actual)
Primary Completion Date
July 20, 2021 (Actual)
Study Completion Date
July 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Loss of Consciousness

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 (0.02 mg/kg, age<65)
Arm Type
Active Comparator
Arm Description
Remimazolam of 0.02 mg/kg will be infused in patients aged<65.
Arm Title
2 (0.07 mg/kg, age<65)
Arm Type
Active Comparator
Arm Description
Remimazolam of 0.07 mg/kg will be infused in patients aged<65.
Arm Title
3 (0.12 mg/kg, age<65)
Arm Type
Active Comparator
Arm Description
Remimazolam of 0.12 mg/kg will be infused in patients aged<65.
Arm Title
4 (0.17 mg/kg, age<65)
Arm Type
Active Comparator
Arm Description
Remimazolam of 0.17 mg/kg will be infused in patients aged<65.
Arm Title
5(0.22 mg/kg, age<65)
Arm Type
Active Comparator
Arm Description
Remimazolam of 0.22 mg/kg will be infused in patients aged<65.
Arm Title
6(0.27 mg/kg, age<65)
Arm Type
Active Comparator
Arm Description
Remimazolam of 0.27 mg/kg will be infused in patients aged<65.
Arm Title
7 (0.02 mg/kg, age≥65)
Arm Type
Active Comparator
Arm Description
Remimazolam of 0.02 mg/kg will be infused in patients aged≥65.
Arm Title
8 (0.07 mg/kg, age≥65)
Arm Type
Active Comparator
Arm Description
Remimazolam of 0.07 mg/kg will be infused in patients aged≥65.
Arm Title
9 (0.12 mg/kg, age≥65)
Arm Type
Active Comparator
Arm Description
Remimazolam of 0.12 mg/kg will be infused in patients aged≥65.
Arm Title
10 (0.17 mg/kg, age≥65)
Arm Type
Active Comparator
Arm Description
Remimazolam of 0.17 mg/kg will be infused in patients aged≥65.
Arm Title
11 (0.22 mg/kg, age≥65)
Arm Type
Active Comparator
Arm Description
Remimazolam of 0.22 mg/kg will be infused in patients aged≥65.
Arm Title
12 (0.27 mg/kg, age≥65)
Arm Type
Active Comparator
Arm Description
Remimazolam of 0.27 mg/kg will be infused in patients aged≥65.
Intervention Type
Drug
Intervention Name(s)
0.02 mg/kg, age<65
Intervention Description
Remimazolam of 0.02 mg/kg will be infused in patients aged<65.
Intervention Type
Drug
Intervention Name(s)
0.07 mg/kg, age<65
Intervention Description
Remimazolam of 0.07 mg/kg will be infused in patients aged<65.
Intervention Type
Drug
Intervention Name(s)
0.12 mg/kg, age<65
Intervention Description
Remimazolam of 0.12 mg/kg will be infused in patients aged<65.
Intervention Type
Drug
Intervention Name(s)
0.17 mg/kg, age<65
Intervention Description
Remimazolam of 0.17 mg/kg will be infused in patients aged<65.
Intervention Type
Drug
Intervention Name(s)
0.22 mg/kg, age<65
Intervention Description
Remimazolam of 0.22 mg/kg will be infused in patients aged<65.
Intervention Type
Drug
Intervention Name(s)
0.27 mg/kg, age<65
Intervention Description
Remimazolam of 0.27 mg/kg will be infused in patients aged<65.
Intervention Type
Drug
Intervention Name(s)
0.02 mg/kg, age≥65
Intervention Description
Remimazolam of 0.02 mg/kg will be infused in patients aged≥65.
Intervention Type
Drug
Intervention Name(s)
0.07 mg/kg, age≥65
Intervention Description
Remimazolam of 0.07 mg/kg will be infused in patients aged≥65.
Intervention Type
Drug
Intervention Name(s)
0.12 mg/kg, age≥65
Intervention Description
Remimazolam of 0.12 mg/kg will be infused in patients aged≥65
Intervention Type
Drug
Intervention Name(s)
0.17 mg/kg, age≥65
Intervention Description
Remimazolam of 0.17 mg/kg will be infused in patients aged≥65.
Intervention Type
Drug
Intervention Name(s)
0.22 mg/kg, age≥65
Intervention Description
Remimazolam of 0.22 mg/kg will be infused in patients aged≥65.
Intervention Type
Drug
Intervention Name(s)
0.27 mg/kg, age≥65
Intervention Description
Remimazolam of 0.27 mg/kg will be infused in patients aged≥65.
Primary Outcome Measure Information:
Title
Loss of consciousness within 5 minutes
Description
Loss of consciousness will be evaluated at 5 minutes after infusion.
Time Frame
At 5 minutes after infusion
Secondary Outcome Measure Information:
Title
Time to loss of consciousness
Description
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)
Title
blood pressure
Description
Blood pressure will be measured at 0, 1, 2, 3, 4, 5 minutes after infusion.
Time Frame
At 5 minutes after infusion
Title
heart rate
Description
Heart rate will be measured at 0, 1, 2, 3, 4, 5 minutes after infusion.
Time Frame
At 5 minutes after infusion
Title
sedline
Description
Sedline will be measured at 0, 1, 2, 3, 4, 5 minutes after infusion.
Time Frame
At 5 minutes after infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong Woo Han
Organizational Affiliation
GangnamSeveracne Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
35562226
Citation
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.
Results Reference
derived

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Remimazolam Bolus for General Anesthesia

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