Anesthesia Induction With Intravenous Bolus or Continuous Infusion of Remimazolam

Sponsor

Korea University Guro Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05423080

Collaborator

(none)

100

Enrollment

Location

Arms

4.9

Anticipated Duration (Months)

20.3

Patients Per Site Per Month

Study Details

Study Description

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.)

Condition or Disease	Intervention/Treatment	Phase
Adult Anesthesia, General	Drug: Bolus injection of remimazolam Drug: Infusion of remimazolam	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official 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

Actual Study Start Date :

Aug 3, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bolus group Participants in this group are administered remimazolam via the bolus injection method during anesthesia induction.	Drug: 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. Other Names: Bolus injection of Byfavo
Active Comparator: Infusion group Participants in this group are administered remimazolam via the continuous infusion method during anesthesia induction.	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. Other Names: Continuous infusion of Byfavo

Arm

Intervention/Treatment

Experimental: Bolus group

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

Drug: 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.

Other Names:

Bolus injection of Byfavo

Active Comparator: Infusion group

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

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.

Other Names:

Continuous infusion of Byfavo

Outcome Measures

Primary Outcome Measures

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

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.
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.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea University Guro Hospital	Seoul		Korea, Republic of	08308

Sponsors and Collaborators

Korea University Guro Hospital

Investigators

Principal Investigator: Byung Gun Lim, MD, PhD, Korea University Guro Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Byung Gun Lim, Professor, Korea University Guro Hospital

ClinicalTrials.gov Identifier:

NCT05423080

Other Study ID Numbers:

2022GR0114

First Posted:

Jun 21, 2022

Last Update Posted:

Aug 5, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 5, 2022