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Not yet recruitingNCT05536323Updated Jun 2, 2023

Bolus Versus Continuous Remimazolam for Anesthetic Induction

An interventional study of Remimazolam bolus and Remimazolam continuous in Hypotension on Induction, sponsored by Kangbuk Samsung Hospital. Not yet recruiting. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-06-02.

Sponsored by Kangbuk Samsung Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Hypotension on Induction

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03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • arrythmia
  • liver dysfunction
  • kidney dysfunction
  • uncontrolled hypertension
  • uncontrolled diabetes mellitus
  • allergic to benzodiazepines
  • heart failure
  • drug intoxication
  • alcohol intoxication
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
62 participants (estimated)

Study arms

  • Experimental
    Bolus

    Anesthetic induction with bolus remimazolam administration

    Drug: Remimazolam bolus

  • Experimental
    Continuous

    Anesthetic induction with continuous remimazolam administration

    Drug: Remimazolam continuous

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

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What researchers measure

Primary outcomes

  1. Incidence of hypotension

    Systolic pressure below 90 mmHg

    Time frame: 10 minutes after anesthetic induction

Secondary outcomes

  1. Incidence of bradycardia

    heart rate below 40 beats per minute

    Time frame: 10 minutes after anesthetic induction

  2. The lowest systolic blood pressure

    The lowest systolic blood pressure

    Time frame: 10 minutes after anesthetic induction

  3. Number of participants with vasoactive drug use

    Use of vasoactive drug for the blood pressure or the heart rate management

    Time frame: 10 minutes after anesthetic induction

  4. Time to loss of consciousness

    Time from drug administration to loss of consciousness

    Time frame: 10 minutes after anesthetic induction

  5. Dosage of remimazolam

    Total dose or remimazolam used for anesthetic induction

    Time frame: 10 minutes after anesthetic induction

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05536323
Lead sponsor
Kangbuk Samsung Hospital
Responsible party
Eunah Cho, MD (Assistant Professor, Kangbuk Samsung Hospital) — Principal investigator
First posted
Sep 10, 2022
Start date
Jul 1, 2023 (estimated)
Primary completion
Nov 1, 2023 (estimated)
Completion
Dec 1, 2023 (estimated)
Last update
Jun 2, 2023

Study contacts

Cho E Ah, PhD
Contact
eunahthereal@gmail.com
82-2001-4657
Cho E Ah
principal investigator · Kangbuk Samsung Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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