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Clinical Trials/NCT05536323
NCT05536323
Not yet recruiting
Not Applicable

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

Kangbuk Samsung Hospital0 sites62 target enrollmentJuly 1, 2023

Overview

Phase
Not Applicable
Intervention
Remimazolam bolus
Conditions
Hypotension on Induction
Sponsor
Kangbuk Samsung Hospital
Enrollment
62
Primary Endpoint
Incidence of hypotension
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2023
End Date
December 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kangbuk Samsung Hospital
Responsible Party
Principal Investigator
Principal Investigator

Eunah Cho, MD

Assistant Professor

Kangbuk Samsung Hospital

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

Arms & Interventions

Bolus

Anesthetic induction with bolus remimazolam administration

Intervention: Remimazolam bolus

Continuous

Anesthetic induction with continuous remimazolam administration

Intervention: Remimazolam continuous

Outcomes

Primary Outcomes

Incidence of hypotension

Time Frame: 10 minutes after anesthetic induction

Systolic pressure below 90 mmHg

Secondary Outcomes

  • Incidence of bradycardia(10 minutes after anesthetic induction)
  • The lowest systolic blood pressure(10 minutes after anesthetic induction)
  • Number of participants with vasoactive drug use(10 minutes after anesthetic induction)
  • Time to loss of consciousness(10 minutes after anesthetic induction)
  • Dosage of remimazolam(10 minutes after anesthetic induction)

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