Bolus Versus Continuous Remimazolam for Anesthetic Induction
Comparison of the Incidence of Hypotension in Bolus Versus Continuous Administration of Remimazolam During Anesthesia Induction
1 other identifier
interventional
62
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2023
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2022
CompletedFirst Posted
Study publicly available on registry
September 10, 2022
CompletedStudy Start
First participant enrolled
July 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedJune 2, 2023
May 1, 2023
4 months
September 5, 2022
May 31, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of hypotension
Systolic pressure below 90 mmHg
10 minutes after anesthetic induction
Secondary Outcomes (5)
Incidence of bradycardia
10 minutes after anesthetic induction
The lowest systolic blood pressure
10 minutes after anesthetic induction
Number of participants with vasoactive drug use
10 minutes after anesthetic induction
Time to loss of consciousness
10 minutes after anesthetic induction
Dosage of remimazolam
10 minutes after anesthetic induction
Study Arms (2)
Bolus
EXPERIMENTALAnesthetic induction with bolus remimazolam administration
Continuous
EXPERIMENTALAnesthetic induction with continuous remimazolam administration
Interventions
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
Eligibility Criteria
You may qualify if:
- scheduled for elective surgery under general anesthesia
- adult patient (over 19 years old)
- American Society of Anesthesiology Physical Status I-III
You may not qualify if:
- arrythmia
- liver dysfunction
- kidney dysfunction
- uncontrolled hypertension
- uncontrolled diabetes mellitus
- allergic to benzodiazepines
- heart failure
- drug intoxication
- alcohol intoxication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- PRINCIPAL INVESTIGATOR
Cho E Ah
Kangbuk Samsung Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 5, 2022
First Posted
September 10, 2022
Study Start
July 1, 2023
Primary Completion
November 1, 2023
Study Completion
December 1, 2023
Last Updated
June 2, 2023
Record last verified: 2023-05