Hypotension
Conditions
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.
Interventions
DRUGBolus of remimazolam
0.19-0.25 mg/kg for 60-80 years old 0.14-0.19 mg/kg for \>80 years old
DRUGContinuous infusion of remimazolam
12 mg/kg/hr until loss of consciousness
Sponsors
Kangbuk Samsung Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of hypotension | 10 minutes after intubation | Systolic blood pressure \< 90 mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of bradycardia | 10 minutes after intubation | Heart rate \< 40 beats per minute |
| Number of participants with use of any vasopressors | 10 minutes after intubation | Use of ephedrine, phenylephrine |
| Lowest systolic blood pressure | 10 minutes after intubation | The lowest systolic blood pressure measured within10 minutes after intubation |
| Time to loss of consciousness | 10 minutes after intubation | Time to loss of consciousness. Loss of consciousness is assessed by the loss of response to shoulder shaking. |
| Total remimazolam used for anesthetic induction | 10 minutes after intubation | Sum of remimazolam used during anesthetic induction |
Countries
South Korea
Outcome results
None listed