Breast cancer
Conditions
Interventions
Remimazolam
Propofol
Sponsors
Kyushu University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The following criteria are necessary in order to meet eligibility requirements for the current study. (1) Patients must provide written informed consent by their own free will. (2) Patients must be aged 20 years or older and must be under 65 years of age. (3) Patients must be undergoing breast surgery under general anesthesia.
Exclusion criteria
Exclusion criteria: Patients should be excluded if any one of the following criteria apply. (1) Patients with a history of hypersensitivity to remimazolam or propofol. (2) Patients with egg or soybean oil allergies, acute angle-closure glaucoma, myasthenia gravis, serious disease complications, or a history of allergies. (3) Patients with an ASA (American society of anesthesiologists) physical status of IV or higher, shock, or coma. (4) Patients who are judged as inappropriate for inclusion in the study. (5) Patients with impaired cognitive function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint examined in this RCT is the assessment of anterograde amnesia. (1) The number of posters remembered 24 hours after surgery among four posters shown after awakening from anesthesia. Specifically, after awakening from anesthesia and being able to say their names, patients are to be shown four posters. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) The number of events remembered from prior to the start of anesthesia: ambulatory entry, bed transfer, vein insertion, BIS monitor attachment to the forehead, and mask fitting, and based on whether the patient remembers the poster (see Appendix) shown before the induction of anesthesia. (2) The amount of analgesic medication from the time the patient returns to the ward until 24 h after surgery. (3) Immediate postoperative pain numerical rating scale (NRS) values (see Appendix). (4) Pain NRS scores 24 h after leaving the operating room. Safety endpoints 1) Nausea assessed based on the amount of antiemetic medication used immediately after surgery and from the time of returning to the ward until 24 hours after surgery. 2) Time to full awakening. 3) The incidences of hypotension, bradycardia, rhabdomyolysis, and anaphylaxis. | — |
Countries
Japan
Contacts
Public ContactKazuhiro Shirozu
Kyushu University Hospital Anesthesiology
Outcome results
None listed