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NCT05538741 Clinical Trial

Hypotension After Anesthetic Induction With Remimazolam in Elderly

Hypotension Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05538741
Other study ID # RMZ_bolcon_old
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 15, 2023
Est. completion date December 31, 2023

Study information
Verified date May 2023
Source Kangbuk Samsung Hospital
Contact Eunah Cho, PhD
Phone 82-2-2001-4657
Email mintflavored@naver.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 66
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bolus of remimazolam
0.19-0.25 mg/kg for 60-80 years old 0.14-0.19 mg/kg for >80 years old
• Continuous infusion of remimazolam
12 mg/kg/hr until loss of consciousness

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Kangbuk Samsung Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary The incidence of hypotension Systolic blood pressure < 90 mmHg 10 minutes after intubation
Secondary The incidence of bradycardia Heart rate < 40 beats per minute 10 minutes after intubation
Secondary Number of participants with use of any vasopressors Use of ephedrine, phenylephrine 10 minutes after intubation
Secondary Lowest systolic blood pressure The lowest systolic blood pressure measured within10 minutes after intubation 10 minutes after intubation
Secondary Time to loss of consciousness Time to loss of consciousness. Loss of consciousness is assessed by the loss of response to shoulder shaking. 10 minutes after intubation
Secondary Total remimazolam used for anesthetic induction Sum of remimazolam used during anesthetic induction 10 minutes after intubation
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