None listed
Conditions
Interventions
Drug : [Investigational product]
Study drug: HNP-2001 50 mg
Control drug: Propofol 10 mg/mL
[Duration of administration] 1 day
[Mode of study drug administration]
Study drug will be administered by i
general condition until the end of surgery.
[Mode of control drug administration]
In subjects less than 55 years of age, control drug 40 mg will be administered intravenously every 10 seconds by bolu
general condition until the end of surgery.
Sponsors
Hana Pharm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female = 18 years of age at the day of consent 2) Patients scheduled for surgery requiring ventilator with endotracheal intubation 3) American Society of Anesthesiologists (ASA) Physical status ? or ? 4) Patients who voluntarily choose to participate in the study and sign a written informed consent form
Exclusion criteria
Exclusion criteria: 1) Patients scheduled to have local anesthesia (spinal subarachnoid anesthesia, epidural anesthesia, peripheral nerve block) between Day 1 operating room entrance and the end of endotracheal intubation 2) Planned to have hepatic resection or liver transplantation during the surgery 3) Planned to use heart-lung machine during the surgery (e.g., cardiotomy, heart transplantation, lung transplantation, etc.) 4) Uncontrolled hypertension (SBP = 180 mmHg [= 160 mmHg for patients taking anti-hypertensives] at screening) 5) Uncontrolled diabetes mellitus (HbA1c = 9% at screening) 6) Patients with chronic obstructive pulmonary disease requiring treatment or patients who require the maintenance of endotracheal intubation for post-operative respiration management expected to result in difficulty in immediate removal of intubation 7) Resistance to benzodiazepines 8) Hypersensitivity to benzodiazepines, propofol, remifentanil, fentanil citrate, rocuronium bromide, sugammadex, flumazenil, and other anesthetics 9) Investigator otherwise judges that the patient is not eligible for the study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of general anesthesia | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to loss of consciousness after administration of the investigational product;Intra-operative awakening and body movement;Time to opening eyes from the end of investigational product administration;Controllability of depth of anesthesia;Safety Evaluation | — |
Countries
Korea, Republic of
Contacts
Public ContactJeong-Hwa Seo
Seoul National University Hospital
Outcome results
None listed