Anesthesia Induction With Intravenous Bolus or Continuous Infusion of Remimazolam

Anesthesia, General Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05423080
• Other study ID #: 2022GR0114
• Status: Completed
• Phase: Phase 4
• Start date: August 3, 2022
• Est. completion date: November 25, 2022

Study information

• Verified date: December 2022
• Source: Korea University Guro Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 25, 2022
• Est. primary completion date: November 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adult
• Anesthesia, General

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Korea University Guro Hospital	Hana Pharm Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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