Vertebral compression fracture
Conditions
Interventions
The Dexmedetomidine Group:Dexmedetomidine nasal spray
Sodium Chloride Solution Group:Normal saline
Sponsors
Wenjiang District People's Hospital
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 65 years old 2. Intend to undergo percutaneous vertebroplasty (PKP/PVP) under local anesthesia
Exclusion criteria
Exclusion criteria: 1. Known allergy to dexmedetomidine; 2. Systolic blood pressure >=180mmHg and/or diastolic blood pressure >=110mmHg; 3. Patients with vertebral fractures caused by tumors; 4. Known or suspected difficult airway; 5. Uncooperative patients (such as those with Alzheimer's disease); 6. Patients with severe hepatic and renal dysfunction; 7. Patients with a history of nasal surgery; 8. Patients who participated in and received other clinical trial drugs within 1 month before medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The magnitude of increase in the patient's systolic blood pressure during the injection of bone cement; | — |
Secondary
| Measure | Time frame |
|---|---|
| The magnitude of increase in blood pressure (?SBP, ?MAP) in patients during the injection of local anesthetics;VAS score during injection of local anesthetic;VAS score during bone cement injection;Incidence of body movement during surgery;Bone cement leakage rate;Incidence of nerve injury;Satisfaction score (surgeon and patient);Surgical duration;Incidence rate of adverse events;VAS score 1 hour after surgery;VAS score 24 hours after surgery;Mortality rate within 28 days after surgery; | — |
Countries
China
Contacts
Public ContactXu Liu
Wenjiang District People's Hospital
Outcome results
None listed