Bolus Versus Continuous Remimazolam for Anesthetic Induction

NCT ID: NCT05536323

Last Updated: 2023-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2023-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hypotension on Induction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Bolus

Anesthetic induction with bolus remimazolam administration

Group Type EXPERIMENTAL

Remimazolam bolus

Intervention Type DRUG

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

Continuous

Anesthetic induction with continuous remimazolam administration

Group Type EXPERIMENTAL

Remimazolam continuous

Intervention Type DRUG

Remimazolam 12 mg/kg/hr

Interventions

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Remimazolam 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

Intervention Type DRUG

Remimazolam continuous

Remimazolam 12 mg/kg/hr

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kangbuk Samsung Hospital

OTHER

Sponsor Role lead

Responsible Party

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Eunah Cho, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cho E Ah

Role: PRINCIPAL_INVESTIGATOR

Kangbuk Samsung Hospital

Central Contacts

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Cho E Ah, PhD

Role: CONTACT

82-2001-4657

Other Identifiers

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RMZ_bolcon

Identifier Type: -

Identifier Source: org_study_id

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