Back to resultsBolus Versus Continuous Remimazolam for Anesthetic Induction
Primary Purpose
Hypotension on Induction
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Remimazolam bolus
Remimazolam continuous
Sponsored by
About this trial
This is an interventional other trial for Hypotension on Induction
Eligibility Criteria
Inclusion Criteria:
- scheduled for elective surgery under general anesthesia
- adult patient (over 19 years old)
- American Society of Anesthesiology Physical Status I-III
Exclusion Criteria:
- arrythmia
- liver dysfunction
- kidney dysfunction
- uncontrolled hypertension
- uncontrolled diabetes mellitus
- allergic to benzodiazepines
- heart failure
- drug intoxication
- alcohol intoxication
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Bolus
Continuous
Arm Description
Anesthetic induction with bolus remimazolam administration
Anesthetic induction with continuous remimazolam administration
Outcomes
Primary Outcome Measures
Incidence of hypotension
Systolic pressure below 90 mmHg
Secondary Outcome Measures
Incidence of bradycardia
heart rate below 40 beats per minute
The lowest systolic blood pressure
The lowest systolic blood pressure
Number of participants with vasoactive drug use
Use of vasoactive drug for the blood pressure or the heart rate management
Time to loss of consciousness
Time from drug administration to loss of consciousness
Dosage of remimazolam
Total dose or remimazolam used for anesthetic induction
Full Information
NCT ID
NCT05536323
First Posted
September 5, 2022
Last Updated
May 31, 2023
Sponsor
Kangbuk Samsung Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05536323
Brief Title
Bolus Versus Continuous Remimazolam for Anesthetic Induction
Official Title
Comparison of the Incidence of Hypotension in Bolus Versus Continuous Administration of Remimazolam During Anesthesia Induction
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kangbuk Samsung 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
Remimazolam is a newly introduced intravenous anesthetic, with rapid onset and offset. Although it is known to cause less hemodynamic instability, the incidence hypotension is the one of the most frequent adverse events with its use. For anesthetic induction, remimazolam can be used either as bolus dose or as continuous infusion.
This study is aimed to investigate the incidence of hypotension after anesthetic induction with bolus (0.14-0.33 mg/kg) or continuous (12 mg/kg/hr) remimazolam administration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension on Induction
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bolus
Arm Type
Experimental
Arm Description
Anesthetic induction with bolus remimazolam administration
Arm Title
Continuous
Arm Type
Experimental
Arm Description
Anesthetic induction with continuous remimazolam administration
Intervention Type
Drug
Intervention Name(s)
Remimazolam bolus
Intervention Description
Remimazolam bolus 0.14-0.33 mg/kg 0.25-0.33 mg/kg, <40 years 0.19-0.25 mg/kg, 60-80 years 0.14-0.19 mg/kg, >80 years
Intervention Type
Drug
Intervention Name(s)
Remimazolam continuous
Intervention Description
Remimazolam 12 mg/kg/hr
Primary Outcome Measure Information:
Title
Incidence of hypotension
Description
Systolic pressure below 90 mmHg
Time Frame
10 minutes after anesthetic induction
Secondary Outcome Measure Information:
Title
Incidence of bradycardia
Description
heart rate below 40 beats per minute
Time Frame
10 minutes after anesthetic induction
Title
The lowest systolic blood pressure
Description
The lowest systolic blood pressure
Time Frame
10 minutes after anesthetic induction
Title
Number of participants with vasoactive drug use
Description
Use of vasoactive drug for the blood pressure or the heart rate management
Time Frame
10 minutes after anesthetic induction
Title
Time to loss of consciousness
Description
Time from drug administration to loss of consciousness
Time Frame
10 minutes after anesthetic induction
Title
Dosage of remimazolam
Description
Total dose or remimazolam used for anesthetic induction
Time Frame
10 minutes after anesthetic induction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
scheduled for elective surgery under general anesthesia
adult patient (over 19 years old)
American Society of Anesthesiology Physical Status I-III
Exclusion Criteria:
arrythmia
liver dysfunction
kidney dysfunction
uncontrolled hypertension
uncontrolled diabetes mellitus
allergic to benzodiazepines
heart failure
drug intoxication
alcohol intoxication
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cho E Ah, PhD
Phone
82-2001-4657
Email
eunahthereal@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cho E Ah
Organizational Affiliation
Kangbuk Samsung Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Bolus Versus Continuous Remimazolam for Anesthetic Induction
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