Anesthesia Induction With Intravenous Bolus or Continuous Infusion of Remimazolam

NCT05423080 | Completed Phase 4

• 1 other identifier: 2022GR0114
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• MOAA/SS (sedation level)

  The investigators will measure MOAA/SS from the start of remimazolam administration to loss of consciousness (LOC), and compare it between the two groups.

  From initiation of remimazolam to LOC (up to 5 minutes)

Secondary Outcomes (3)

• Time from initiation of drug administration to bispectral index(BIS) <60

  From initiation of remimazolam to BIS <60 (up to 10 minutes)

• BIS

  From initiation of remimazolam to 15 minutes after surgical incision

• Hemodynamic stability (i.e. blood pressure, heart rate)

  From initiation of remimazolam to 15 minutes after surgical incision

Study Arms (2)

Bolus group

EXPERIMENTAL

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

Drug: Bolus injection of remimazolam

Infusion group

ACTIVE COMPARATOR

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

Drug: Infusion of remimazolam

Interventions

Bolus injection of remimazolam 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.

Also known as: Bolus injection of Byfavo

Bolus group

Infusion of remimazolam 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.

Also known as: Continuous infusion of Byfavo

Infusion group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Korea University Guro Hospital: lead
• Hana Pharm Co., Ltd.: collaborator

Study Sites (1)

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Study Officials

• Byung Gun Lim, MD, PhD

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 21, 2022
• Study Start: August 3, 2022
• Primary Completion: November 25, 2022
• Study Completion: November 25, 2022
• Last Updated: December 9, 2022

Record last verified: 2022-12

Locations

KR (1)