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Clinical trial

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

ID
Name
RMZ_bolcon_old
Description
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.
Trial arms
Trial start
2023-06-15
Estimated PCD
2023-12-31
Trial end
2023-12-31
Status
Not yet recruiting
Treatment
Bolus of remimazolam
0.19-0.25 mg/kg for 60-80 years old 0.14-0.19 mg/kg for \>80 years old
Arms:
Bolus
Continuous infusion of remimazolam
12 mg/kg/hr until loss of consciousness
Arms:
Continuous
Size
66
Primary endpoint
The incidence of hypotension
10 minutes after intubation
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 * Unable to understand and consent voluntarily
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 66, 'type': 'ESTIMATED'}}
Updated at
2023-06-02

1 organization

1 product

1 indication

Organization
Kangbuk Samsung Hospital
Product
Remimazolam
Indication
Low blood pressure