Clinical trial

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

Name

RMZ_bolcon

Description

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.

Trial arms

Trial start

2023-07-01

Estimated PCD

2023-11-01

Trial end

2023-12-01

Status

Not yet recruiting

Treatment

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

Arms:

Bolus

Remimazolam continuous

Remimazolam 12 mg/kg/hr

Arms:

Continuous

Size

Primary endpoint

Incidence of hypotension

10 minutes after anesthetic 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 62, 'type': 'ESTIMATED'}}

Updated at

2023-06-02

1 organization

1 product

1 indication

Organization

Kangbuk Samsung Hospital

Product

Remimazolam

Indication

Hypotension