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NCT Number: NCT05423080

Anesthesia Induction With Intravenous Bolus or Continuous Infusion of Remimazolam

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.)

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Key information

Conditions

Adult Anesthesia, General

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Korea University Guro Hospital

Seoul, 08308, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Bolus injection of Byfavo

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.

Other names: Continuous infusion of Byfavo

Primary outcomes

  1. MOAA/SS (sedation level)

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. BIS

    Time frame: 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.

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Korea University Guro Hospital

Other

Collaborators

  • Hana Pharm Co., Ltd.

Registry information

Official study title

Comparison of Anesthetic Induction Time and Change of Bispectral Index Between Intravenous Bolus Administration and Continuous Infusion of Remimazolam for Anesthetic Induction: a Prospective Randomized Single-blind Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 21, 2022
Registry last updated
Dec 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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