Perioperative neurocognitive impairment
Conditions
Interventions
Local anesthesia + Orcelidine group:The operation was performed with oxelidine for analgesia
Local anesthesia + Sufentanil group:The operation was performed with sufentanil for analgesia
Sponsors
The Second Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age>=65y, gender is not limited; 2. ASA Level I-III; 3. Body mass index (BMI) 18-30 kg/m^2 (including boundary value); 4. Proposed spinal minimally invasive surgery, including PKP, endoscopic lumbar discectomy, endoscopic lumbar nucleus pulpotomy, and radiofrequency intervertebral disc ablation; 5. Good mental state, preoperative MMSE score >27 points; 6. No obvious abnormal diseases of respiratory and circulatory system, such as AECOPD, pulmonary heart disease, heart failure, etc.; 7. Vital signs during screening period: respiratory rate 10-20 times/min; Pulse oxygen saturation (SpO2) >=92% when breathing air; Systolic blood pressure (SBP) 90-160mmHg, diastolic blood pressure (DBP) 60-100mmHg; Heart rate 55-100 beats/min; 8. Able to understand the procedures and methods of this study, willing to sign informed consent and strictly abide by this test protocol to complete this study.
Exclusion criteria
Exclusion criteria: 1. Patients with preoperative cognitive dysfunction had MMSE scores <24; 2.Known or suspected allergy or contraindication to the components of the investigational drug or the prescribed procedural drug use; 3. Suspected epilepsy or severe liver and kidney insufficiency; 4. Is or has been addicted to drugs; 5. Any of the following respiratory management risks existed before or during screening: 1) history of asthma, wheezing; 2) Patients with sleep apnea syndrome; 6. Participating in other drug clinical studies; 7. Subjects with any other factors deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of postoperative delirium; | — |
Secondary
| Measure | Time frame |
|---|---|
| Heart rate;Blood pressure ;Oxygen saturation;Respiratory rate;Temperature;Brain state index;NRS scores ;3D-CAM scores ; s100ß;The number of additional analgesic drugs during the operation;Intraoperative use of norepinephrine and atropine; | — |
Countries
China
Contacts
Public ContactChen Ying
The Second Affiliated Hospital of Kunming Medical University
Outcome results
None listed