None
Conditions
Interventions
Esk-IM Group:Thirty minutes prior to surgery, a 3 mL mixture containing 2 mg of midazolam and 25 mg of esketamine is injected into the gluteus maximus. For local anesthesia during the procedure, 20 mL
Esk-LA Group:Thirty minutes prior to surgery, 2 mL of midazolam (2 mg) is injected into the gluteus maximus. For local anesthesia during the procedure, a 20 mL mixture of 1% lidocaine and 25 mg of esk
Control Group:Thirty minutes prior to surgery, 2 mL of midazolam (2 mg) is injected into the gluteus maximus. For local anesthesia during the procedure, 20 mL of 1% lidocaine is administered.
Sponsors
Ningbo Medical Center Lihuili Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients undergoing percutaneous kyphoplasty of the lumbar or thoracic spine. 2.Age between 60 and 80 years. 3.American Society of Anesthesiologists (ASA) classification I–III. 4.Body Mass Index (BMI) between 18.5 and 25 kg/m^2. 5.Montreal Cognitive Assessment (MoCA) score >= 18. 6.Patient Health Questionnaire (PHQ-9) score <= 9.
Exclusion criteria
Exclusion criteria: 1.Allergy to lidocaine. 2.Patients deemed unable to undergo surgery under local anesthesia by the surgeon. 3.Patients with severe cognitive impairment unable to complete relevant assessments (MoCA score = 10) or other severe psychiatric disorders (e.g., bipolar disorder, schizophrenia).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PHQ-9 Score;MoCA Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS Score;Intraoperative MAP (Mean Arterial Pressure);Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) Scale; Adverse Reactions;Changes in s100ß;Intraoperative heart rate;8-OHdG;WBC level;CRP;IL-6;Blood cortisol; | — |
Countries
China
Contacts
Public ContactLongyuan Zhou
Ningbo Medical Center Lihuili Hospital
Outcome results
None listed