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Bolus Versus Continuous Remimazolam for Anesthetic Induction

Comparison of the Incidence of Hypotension in Bolus Versus Continuous Administration of Remimazolam During Anesthesia Induction

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05536323
Enrollment
62
Registered
2022-09-10
Start date
2023-07-01
Completion date
2023-12-01
Last updated
2023-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension on Induction

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.

Interventions

DRUGRemimazolam bolus

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

DRUGRemimazolam continuous

Remimazolam 12 mg/kg/hr

Sponsors

Kangbuk Samsung Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of hypotension10 minutes after anesthetic inductionSystolic pressure below 90 mmHg

Secondary

MeasureTime frameDescription
Incidence of bradycardia10 minutes after anesthetic inductionheart rate below 40 beats per minute
The lowest systolic blood pressure10 minutes after anesthetic inductionThe lowest systolic blood pressure
Number of participants with vasoactive drug use10 minutes after anesthetic inductionUse of vasoactive drug for the blood pressure or the heart rate management
Time to loss of consciousness10 minutes after anesthetic inductionTime from drug administration to loss of consciousness
Dosage of remimazolam10 minutes after anesthetic inductionTotal dose or remimazolam used for anesthetic induction

Contacts

Primary ContactCho E Ah, PhD
eunahthereal@gmail.com82-2001-4657

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026