Post-Induction Hypotension
Conditions
Interventions
Propofol Arm:Anesthesia was induced with an intravenous bolus of propofol (1 mg/kg) administered over 60 seconds.
Fospropofol Disodium Arm:Anesthesia was induced with an intravenous bolus of fospropofol disodium(10 mg/kg) administered over 60 seconds.
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
65 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age 65-85 years; 2. Scheduled to undergo elective non-cardiac, non-neurosurgical surgery under general anesthesia; 3. ASA Physical Status Classification I-III; 4. Agree to participate in the study and voluntarily provide signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Obesity (BMI >= 28 kg/m²); 2. Uncontrolled preoperative hypertension (SBP > 180 mmHg or DBP > 110 mmHg); 3. History of allergy to propofol, fospropofol disodium, or lipid emulsion; 4. Severe cardiovascular disease: e.g., severe heart failure (NYHA Class III-IV), acute myocardial infarction, severe arrhythmias (such as ventricular arrhythmias, persistent atrial fibrillation, etc.); 5. End-stage renal disease or severe renal dysfunction (glomerular filtration rate = 3). 9. Neurological or psychiatric disorders: severe cognitive impairment, history of severe mental illness, or patients unable to undergo effective preoperative assessment. 10. Patients with an estimated surgical duration of 4 hours. 11. Patients currently participating in other drug trials or who have participated in other clinical studies during the research period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of post-induction hypotension within 15 minutes after general anesthesia induction.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under the threshold (AUT) for MAP below baseline values and MAP < 65 mmHg within 15 minutes after anesthesia induction.;Incidence of severe hypotension within 15 minutes after anesthesia induction (defined as MAP < 60 mmHg or a decrease of more than 30% from baseline).;Time to loss of consciousness after anesthesia induction (defined as the time from initiation of anesthesia induction to MOAA/S score = 1).;Use of vasoactive drugs within 15 minutes after anesthesia induction.;Incidence of injection pain and paresthesia during anesthesia induction.;Incidence of severe hypotension during surgery (defined as MAP < 60 mmHg or a decrease of more than 30% from baseline).;Use of vasoactive drugs during surgery.;Emergence time (defined as the time from discontinuation of anesthetics to appropriate response to commands).;Extubation time (defined as the time from discontinuation of anesthetics to removal of the endotracheal tube or laryngeal mask).;Length of stay in the post-anesthesia care unit (PACU).;Quality of Recovery-15 (QoR-15) score on the first postoperative day.; | — |
Countries
China
Contacts
Public ContactShen Qiying, Liu Xuesheng
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed