Anesthesia Induction With Intravenous Bolus or Continuous Infusion of Remimazolam

NCT ID: NCT05423080

Last Updated: 2022-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-03
• Study Completion Date: 2022-11-25

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.)

Conditions

Adult; Anesthesia, General

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bolus group

Participants in this group are administered remimazolam via the bolus injection method during anesthesia induction.

Group Type: EXPERIMENTAL

Bolus injection of remimazolam

Intervention Type: DRUG

Participants in this group are administered 0.2 mg/kg remimazolam via the bolus injection method for 20 seconds during anesthesia induction. If loss of consciousness (LOC) does not occur, the investigators will administer additional doses of 0.05 mg/kg repeatedly until LOC occurs.

Infusion group

Participants in this group are administered remimazolam via the continuous infusion method during anesthesia induction.

Group Type: ACTIVE_COMPARATOR

Infusion of remimazolam

Intervention Type: DRUG

Participants in this group are administered remimazolam at a rate of 6 mg/kg/hr via the continuous infusion method during anesthesia induction. If loss of consciousness (LOC) does not occur, the investigators will escalate infusion dose to 12 mg/kg/hr until LOC occurs.

Interventions

Bolus injection of remimazolam

Participants in this group are administered 0.2 mg/kg remimazolam via the bolus injection method for 20 seconds during anesthesia induction. If loss of consciousness (LOC) does not occur, the investigators will administer additional doses of 0.05 mg/kg repeatedly until LOC occurs.

Intervention Type: DRUG

Infusion of remimazolam

Participants in this group are administered remimazolam at a rate of 6 mg/kg/hr via the continuous infusion method during anesthesia induction. If loss of consciousness (LOC) does not occur, the investigators will escalate infusion dose to 12 mg/kg/hr until LOC occurs.

Intervention Type: DRUG

Other Intervention Names

Bolus injection of Byfavo; Continuous infusion of Byfavo

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hana Pharm Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Korea University Guro Hospital

OTHER

Sponsor Role: lead

Responsible Party

Byung Gun Lim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Byung Gun Lim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Korea University Guro Hospital

Locations

Korea University Guro Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2022GR0114

Identifier Type: -

Identifier Source: org_study_id