Hypertension
Conditions
Interventions
Oral midazolam solution group:Patients received oral midazolam solution at a dose of 0.2 mg/kg 30 minutes before spinal anesthesia. The medication was diluted to a final volume of 10 ml before adminis
Normal saline group:Patients received an equivalent volume of normal saline (10 ml) orally 30 minutes before spinal anesthesia as placebo control. Routine monitoring, including non-invasive blood pres
Sponsors
General Hospital of the Northern Theater Command of the People's Liberation Army of China
Eligibility
Sex/Gender
All
Age
50 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Patients aged 50–70 years, regardless of sex; 2.Patients with a confirmed diagnosis of essential hypertension, who have received regular antihypertensive treatment and have relatively stable blood pressure control before surgery; 3.American Society of Anesthesiologists (ASA) physical status classification II–III; 4.Patients scheduled for elective surgery under spinal anesthesia (including subarachnoid block or epidural anesthesia) after preoperative evaluation; 5.Patients without contraindications to neuraxial anesthesia; 6.Patients who voluntarily participate in the study and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients with severe cardiovascular diseases, respiratory diseases, or significant circulatory or respiratory dysfunction; 2.Patients with severe hepatic or renal insufficiency; 3.Patients with central nervous system disorders, including but not limited to stroke sequelae, epilepsy, or severe cognitive impairment; 4.Patients with preoperative cognitive impairment (Mini-Mental State Examination, MMSE score 30 kg/m^2; 8.Patients with known allergy or hypersensitivity to midazolam, benzodiazepines, or any component of the investigational medication; 9.Patients with severe obstructive sleep apnea syndrome (OSA) or increased risk of respiratory depression; 10.Patients with contraindications to neuraxial anesthesia; 11.Pregnant or breastfeeding women; 12.Patients considered unsuitable for participation in the study by the investigators or those with other conditions that may interfere with study evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in systolic blood pressure at 30 minutes after administration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Preoperative anxiety score assessed by APAIS;Visual analogue scale for anxiety (VAS-A);Ramsay Sedation Score;Time to achieve Ramsay Sedation Score =3;Heart rate changes;Mean arterial pressure changes;Incidence of hypoxemia and respiratory depression;Changes in systolic blood pressure;Changes in diastolic blood pressure;Changes in pulse oxygen saturation (SpO?);Incidence of respiratory depression;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactCao Huijuan
General Hospital of the Northern Theater Command of the People's Liberation Army of China
Outcome results
None listed