Breast tumor
Conditions
Interventions
Fospropofol disodium group:Intravenous administration of sufentanil 0.5 µg/kg (over 60 s), followed by intravenous administration of remimazolam 0.1 mg/kg, then intravenous infusion of propanidid diso
Propofol group:Intravenous administration of sufentanil 0.5 µg/kg (over 60 s), followed by intravenous administration of remimazolam 0.1 mg/kg, then intravenous infusion of propofol 1.0 mg/kg (infused
Sponsors
Guangxi Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years and =2 hours; 4. Undergoing elective breast surgery; 5. Requiring endotracheal intubation under general anesthesia; 6. Able to understand the study procedures and methods, voluntarily participating and providing signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with contraindications to general anesthesia or a history of previous anesthetic complications; 2. Patients with known or suspected allergy or contraindication to propofol injection, opioids, neuromuscular blocking agents, or other related drugs; 3. Patients with a difficult airway or classified as having difficult tracheal intubation (modified Mallampati score >= III); 4. Uncontrolled diabetes or hypertension; 5. Severe hepatic dysfunction or severe renal insufficiency; 6. History of alcoholism or drug dependence; 7. History of abuse or long-term use of anesthetic, sedative, or analgesic drugs; 8. Patients with a history of psychiatric disorders or epilepsy; 9. Patients who participated in any drug clinical trial within 1 month prior to screening; 10. Patients whom the investigator deems to have any other condition making them unsuitable for participation in this trial (e.g., pregnancy or lactation).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of hypotensive events;The effects of the two drugs in maintaining sedation; | — |
Secondary
| Measure | Time frame |
|---|---|
| The dosage of propofol disodium or propofol used per unit time during the maintenance period of anesthesia;The number and dosage of remimazolam rescue administrations during the anesthesia maintenance period (from tracheal intubation to skin suturing completion);The incidence of cardiovascular adverse events (such as sinus bradycardia, sinus tachycardia, hypertension, new-onset arrhythmia, etc.) during anesthesia maintenance;The number and dosage of fospropofol disodium or propofol infusions during the induction of anesthesia (from the start of anesthesia induction until before tracheal intubation);The time required from drug discontinuation to achieving a MOAA/S score of 5 and the time for tracheal extubation (in minutes);The incidence of acute POD in the PACU (as assessed by the 3D-CAM scale);The incidence of agitation (using the Richmond Agitation-Sedation Scale, or RASS scale) in the PACU;The incidence of PONV in the PACU;The duration of stay in the PACU;Postoperative 1-3 days quality of recovery score (QoR-15);The incidence of postoperative delirium (POD) within 1 to 3 days after surgery (assessed by the 3D-CAM scale); | — |
Countries
China
Contacts
Public ContactLin Fei
Guangxi Medical University Cancer Hospital
Outcome results
None listed