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NCT05536323 Clinical Trial

Bolus Versus Continuous Remimazolam for Anesthetic Induction

Hypotension on Induction Clinical Trial

Official title:
Comparison of the Incidence of Hypotension in Bolus Versus Continuous Administration of Remimazolam During Anesthesia Induction

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05536323
Other study ID # RMZ_bolcon
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2023
Est. completion date December 1, 2023

Study information
Verified date May 2023
Source Kangbuk Samsung Hospital
Contact Cho E Ah, PhD
Phone 82-2001-4657
Email eunahthereal@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Remimazolam is a newly introduced intravenous anesthetic, with rapid onset and offset. Although it is known to cause less hemodynamic instability, the incidence hypotension is the one of the most frequent adverse events with its use. For anesthetic induction, remimazolam can be used either as bolus dose or as continuous infusion. This study is aimed to investigate the incidence of hypotension after anesthetic induction with bolus (0.14-0.33 mg/kg) or continuous (12 mg/kg/hr) remimazolam administration.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 62
Est. completion date December 1, 2023
Est. primary completion date November 1, 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - scheduled for elective surgery under general anesthesia - adult patient (over 19 years old) - American Society of Anesthesiology Physical Status I-III Exclusion Criteria: - arrythmia - liver dysfunction - kidney dysfunction - uncontrolled hypertension - uncontrolled diabetes mellitus - allergic to benzodiazepines - heart failure - drug intoxication - alcohol intoxication

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Remimazolam bolus
Remimazolam bolus 0.14-0.33 mg/kg 0.25-0.33 mg/kg, <40 years 0.19-0.25 mg/kg, 60-80 years 0.14-0.19 mg/kg, >80 years
• Remimazolam continuous
Remimazolam 12 mg/kg/hr

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Kangbuk Samsung Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of hypotension Systolic pressure below 90 mmHg 10 minutes after anesthetic induction
Secondary Incidence of bradycardia heart rate below 40 beats per minute 10 minutes after anesthetic induction
Secondary The lowest systolic blood pressure The lowest systolic blood pressure 10 minutes after anesthetic induction
Secondary Number of participants with vasoactive drug use Use of vasoactive drug for the blood pressure or the heart rate management 10 minutes after anesthetic induction
Secondary Time to loss of consciousness Time from drug administration to loss of consciousness 10 minutes after anesthetic induction
Secondary Dosage of remimazolam Total dose or remimazolam used for anesthetic induction 10 minutes after anesthetic induction
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