Essential Hypertension
Conditions
Interventions
Fospropofol Disodium Group:After preoxygenation, the patient was administered midazolam 2 mg and sufentanil 0.3 µg/kg. The study drug was then administered: in Group F, fospropofol disodium was inject
initial dose 6–8 mg/kg, with supplementary administration at the preset rescue dose as needed).
Propofol group:After preoxygenation, patients were administered midazolam 2 mg and sufentanil 0.3 µg/kg. The study drug was then given as follows: for Group P, propofol was injected intravenously at a
supplemental doses could be administered per predefined rescue criteria.
Sponsors
Quanzhou First Hospital Affiliated to Fujian Medical University
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 30 to 65 years, either gender; 2. Confirmed diagnosis of primary hypertension (systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg); 3. ASA physical status class II–III; 4. Scheduled to undergo surgery under general anesthesia; 5. Written informed consent has been signed by the patient and/or their family members; 6. Relatively stable blood pressure control preoperatively (SBP < 160 mmHg and DBP < 100 mmHg on admission to the operating room); 7. Complete preoperative laboratory data, including liver and renal function tests as well as serum alkaline phosphatase (ALP).
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to fospropofol disodium, propofol, or other components of anesthetic agents; 2. History of myocardial infarction or cerebral infarction within 6 months preoperatively, or presence of severe arrhythmias (e.g., third-degree atrioventricular block), or heart rate = 180 mmHg or DBP >= 110 mmHg) or patients requiring urgent adjustment of antihypertensive regimens; 6. Predicted difficult airway, or surgeries requiring bowel preparation; 7. Pregnant or lactating women, or patients with long-term use of sedative medications or a history of drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of hypotension during the period of general anesthesia induction (from the start of study drug injection to 10 minutes after intubation); | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean arterial pressure and heart rate at each time point;Time to onset of drug effect;Depth of anesthesia; | — |
Countries
China
Contacts
Public ContactWang Yuanfu
Quanzhou First Hospital Affiliated to Fujian Medical University
Outcome results
None listed