Patients with ASA physical status 1-3, scheduled for surgery under total intravenous anesthesia.
Conditions
Interventions
Manually controlled anesthesia (control group): Propofol, remifentanil and rocuronium are titrated manually by the attending anesthesiologist considering patient condition and surgical situation as us
Sponsors
Nagata Osamu
Kenji Shigemi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male and female patients over 20 years old at the time of informed consent 2.Patients with ASA physical status of 1, 2, and 3 who are scheduled for surgery under general anesthesia 3.Patients who understand the contents of this study and are willing to provide written informed consent for participation in this study
Exclusion criteria
Exclusion criteria: 1.Patients with a history of hypersensitive to propofol, remifentanil, rocuronium or sugammadex. 2.Patients who are pregnant or lactating. 3.Patients who are determined not to be eligible for participation in this study by the research director.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of time during which an appropriate state of anesthesia was obtained within the operation time (before and after data cleaning). An appropriate state of anesthesia shall be satisfied when the following three conditions are satisfied; (1) Percentage of time that BIS is maintained within the target range (35-55) from start to end of surgery, (2) The number of incidences of hemodynamic changes (increase in pulse rate and blood pressure) observed from start to end of surgery except within 5 minutes after administration of inotrope, (3) Percentage of time that muscle relaxation is maintained within the target range (0% < T1 <= 10%) from start to end of surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of time that BIS is maintained within the target range (35-55) from start to end of surgery (before and after data cleaning) 2. The number of incidences of hemodynamic changes (increase in pulse rate and blood pressure) observed from start to end of surgery except within 5 minutes after administration of inotrope (before and after data cleaning) 3. Percentage of time that muscle relaxation is maintained within the target range (0% 55) from start to end of surgery (before and after data cleaning) 6. Average and median of BIS (before and after data cleaning) 7. Incidence of body movement (before and after data cleaning) 8. Average dosage of propofol per hour 9. Average dosage of remifentanil per hour 10. Average dosage of rocuronium per hour 11. Time from the end of rocuronium administration to the recovery of %T1 over 100% or of TOF ratio over 0.9 12. Anesthesia-related adverse events that occurred within 48 hours after surgery (incidence of PONV, shivering, delirium and percentage of patients who received additional analgesic agent) | — |
Countries
Japan, Japan only
Contacts
Public ContactOsamu Nagata
Center Hospital of the National Center for Global Health and Medicine
Outcome results
None listed