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
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hypotension
• Hypotension on Induction

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