Anesthesia Induction With Intravenous Bolus or Continuous Infusion of Remimazolam

Phase 4

Completed

• Conditions: Anesthesia, General; Adult
• Interventions: Drug: Infusion of remimazolam; Drug: Bolus injection of remimazolam

• Registration Number: NCT05423080
• Lead Sponsor: Korea University Guro Hospital

Brief Summary

Bolus injection and continuous infusion are two widely used methods for intravenous administration of drugs. Bolus injection possibly leads to a rather high drug plasma concentration temporarily, however, it can induce a rapid onset of drug effects and attain a desired clinical state fast. On the contrary, continuous infusion is able to avoid excessive drug levels in plasma, but it takes longer to achieve the proper effect.

In this study, the investigators hypothesize that the bolus injection of remimazolam can reduce anesthesia induction time when compared to the continuous infusion of remimazolam, and also maintain hemodynamic stability. (The researchers will investigate the effect of the bolus injection of remimazolam during anesthesia induction in terms of its safety and efficacy when compared with the continuous infusion.)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-09
• Study First Submitted QC: 2022-06-14
• Study First Posted: 2022-06-21
• Study Start: 2022-08-03
• Primary Completion: 2022-11-25
• Study Completion: 2022-11-25
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-07
• Last Update Posted: 2022-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Adults 19 years of age or older undergoing surgery under general anesthesia
• ASA I-III

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Exclusion Criteria

• Intraoperative regional blocks (e.g. spinal anesthesia, epidural anesthesia, peripheral nerve block)
• Liver resection or liver transplantation
• Cardiopulmonary bypass
• Uncontrolled HTN (SBP ≧180 mmHg, or ≧160 in patients taking antihypertensive drugs)
• Uncontrolled DM (HbA1c antihypertensive drugs ≧9.0%)
• Total bilirubin ≧3.0 mg/ml or AST or ALS ≧2.5 times the upper limit of normal
• Serum creatinine ≧2.0 mg/ml or ESRD on dialysis
• COPD in need of treatment
• Patients who are expected to have difficulty in tracheal extubation immediately after surgery for postoperative lung management
• Resistance to benzodiazepines
• Hypersensitivity to benzodiazepines, remifentanil, fentanyl citrate, rocuronium, sugammadex, flumazenil, or other anesthetic drugs
• Myasthenia gravis or myasthenic syndrome
• Myocardial infarction, transient ischemic attack, stroke, newly diagnosed coronary artery disease, percutaneous coronary intervention, or coronary artery bypass graft within 6 months
• Implantation of rate-responsive cardiac pacemaker with bioelectrical impedance sensor
• Organic brain disorder, or other neurologic diseases that cannot adequately measure EEG (BIS)
• Severe allergic diseases
• Cognitive impairment that makes it impossible to understand the instructions and informed consent of this study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infusion group	Infusion of remimazolam	Participants in this group are administered remimazolam via the continuous infusion method during anesthesia induction.
Bolus group	Bolus injection of remimazolam	Participants in this group are administered remimazolam via the bolus injection method during anesthesia induction.

Primary Outcome Measures

Name	Time	Method
MOAA/SS (sedation level)	From initiation of remimazolam to LOC (up to 5 minutes)	The investigators will measure MOAA/SS from the start of remimazolam administration to loss of consciousness (LOC), and compare it between the two groups.

Secondary Outcome Measures

Name	Time	Method
Time from initiation of drug administration to bispectral index(BIS) <60	From initiation of remimazolam to BIS <60 (up to 10 minutes)	The investigators measure how long it takes from the start of remimazolam administration to reach BIS \<60.
Hemodynamic stability (i.e. blood pressure, heart rate)	From initiation of remimazolam to 15 minutes after surgical incision	The investigators will evaluate hemodynamic stability from the start of remimazolam administration to 15 minutes after surgical incision
BIS	From initiation of remimazolam to 15 minutes after surgical incision	The investigators will measure BIS from the start of remimazolam administration to 15 minutes after surgical incision.

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of