Status:
COMPLETED
Anesthesia Induction With Intravenous Bolus or Continuous Infusion of Remimazolam
Lead Sponsor:
Korea University Guro Hospital
Collaborating Sponsors:
Hana Pharm Co., Ltd.
Conditions:
Adult
Anesthesia, General
Eligibility:
All Genders
19+ years
Phase:
PHASE4
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, howe...
Eligibility Criteria
Inclusion
- Adults 19 years of age or older undergoing surgery under general anesthesia
- ASA I-III
Exclusion
- 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
Key Trial Info
Start Date :
August 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05423080
Start Date
August 3 2022
End Date
November 25 2022
Last Update
December 9 2022
Active Locations (1)
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1
Korea University Guro Hospital
Seoul, South Korea, 08308