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Clinical Trials/NCT05538741
NCT05538741
Not yet recruiting
Not Applicable

Comparison of the Incidence of Hypotension With Bolus Versus Continuous Remimazolam for Anesthetic Induction in Elderly Patients

Kangbuk Samsung Hospital1 site in 1 country66 target enrollmentJune 15, 2023

Overview

Phase
Not Applicable
Intervention
Bolus of remimazolam
Conditions
Hypotension
Sponsor
Kangbuk Samsung Hospital
Enrollment
66
Locations
1
Primary Endpoint
The incidence of hypotension
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

Even though remimazolam is known to be safely administered without hemodynamic instability, hypotension is the one of the common side effects of remimazolam. Because elderly patients are susceptible to hypotension due to old age, multimodality, and multiple medications, hypotension can be harmful in elderly patients. Remimazolam can be administered either bolus or continuous for anesthetic induction. In our study the investigators aimed to compare the incidence of hypotension after anesthetic induction using remimazolam by bolus injection and continuous infusion in elderly patients.

Registry
clinicaltrials.gov
Start Date
June 15, 2023
End Date
December 31, 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

  • Elderly patients with age over 60 years old
  • scheduled for elective surgery under general anesthesia
  • American Society of Anesthesiology Physical Status I-III

Exclusion Criteria

  • Arrhythmia
  • Liver dysfunction
  • Kidney dysfunction
  • Uncontrolled hypertension
  • Uncontrolled diabetes mellitus
  • Allergic to benzodiazepines
  • Heart failure
  • Drug intoxication
  • Alcoholics
  • Cognitive dysfunction

Arms & Interventions

Bolus

Remimazolam bolus injection for 20 seconds

Intervention: Bolus of remimazolam

Continuous

Remimazolam continuous infusion

Intervention: Continuous infusion of remimazolam

Outcomes

Primary Outcomes

The incidence of hypotension

Time Frame: 10 minutes after intubation

Systolic blood pressure \< 90 mmHg

Secondary Outcomes

  • The incidence of bradycardia(10 minutes after intubation)
  • Number of participants with use of any vasopressors(10 minutes after intubation)
  • Lowest systolic blood pressure(10 minutes after intubation)
  • Time to loss of consciousness(10 minutes after intubation)
  • Total remimazolam used for anesthetic induction(10 minutes after intubation)

Study Sites (1)

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