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Hypotension After Anesthetic Induction with Remimazolam in Elderly

K

Kangbuk Samsung Hospital

Status

Completed

Conditions

Hypotension

Treatments

Drug: Bolus of remimazolam
Drug: Continuous infusion of remimazolam

Study type

Interventional

Funder types

Other

Identifiers

NCT05538741
RMZ_bolcon_old

Details and patient eligibility

About

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.

Enrollment

62 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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
  • Unable to understand and consent voluntarily

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

62 participants in 2 patient groups

Bolus
Experimental group
Description:
Remimazolam bolus injection for 20 seconds
Treatment:
Drug: Bolus of remimazolam
Continuous
Active Comparator group
Description:
Remimazolam continuous infusion
Treatment:
Drug: Continuous infusion of remimazolam

Trial contacts and locations

1

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Central trial contact

Eunah Cho, PhD

Data sourced from clinicaltrials.gov

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