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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05423080
Other study ID # 2022GR0114
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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