Degenerative lumbar disease
Conditions
Interventions
C(CLADS) Group:Drug administration was performed by an Multi-Closed-Loop Anesthesia Delivery System under controlled by anesthesiologist
M (manual) Group:Manual TCI anesthesia management
Sponsors
The Second Affiliated Hospital of Naval Medical University(Shanghai Changzheng Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Patients scheduled for elective posterior lumbar interbody fusion surgery under TIVA; 2.Aged 18-65 years, who have been fully informed about the study and have signed a written informed consent form under full understanding; 3.Meet the American Society of Anesthesiologists physical status classification (ASA classification) I–III; 4.BMI between 18.5 kg/m² and 30 kg/m²; 5.Expected surgery duration longer than 2 hours.
Exclusion criteria
Exclusion criteria: 1.American Society of Anesthesiologists (ASA) Physical Status classification of IV or V. 2.Scheduled for emergency surgery. 3.Anticipated difficult airway based on preoperative assessment. 4.Known allergy or hypersensitivity to propofol, remifentanil, cisatracurium besylate, or dexamethasone, as required by the study protocol. 5.Planned use of inhaled anesthetic agents or combination with other anesthetic techniques (e.g., neuraxial anesthesia, nerve blocks) during the procedure. 6.Pre-existing neurological disorders (e.g., epilepsy, autism spectrum disorder, history of cognitive dysfunction), autonomic nervous system diseases, severe cardiac arrhythmias, or chronic pain unrelated to the lumbar pathology. 7.History of alcohol abuse, substance use disorder, or hearing impairment. 8.Requirement for anticholinergic medication before and/or during the study period. 9.Surgery anticipated to require deliberate hypotensive anesthesia where the target blood pressure would meet criteria for hypotension. 10.Surgery for oncological resection or due to active infection. 11.Any other condition deemed by the investigator to render the patient unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total score of the 15-item Quality of Recovery (QoR-15) scale assessed at 24 hours postoperatively.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The total score of the 15-item Quality of Recovery (QoR-15) scale assessed at 48 hours postoperatively.;The score for each individual item on the 15-item Quality of Recovery (QoR-15) scale.;Percentage of total anesthesia time spent within satisfactory depth (Narcotrend Index [NI] stages D0–E1), excessive depth (NI stages E2–F1), and inadequate depth (NI stages A–C2).;Hemodynamic stability, defined as the percentage of operative time during which both heart rate and mean arterial pressure remained within 20% of baseline values, and the weight- and time-normalized dosage of vasoactive agents.;The weight- and time-normalized dosage of intravenous anesthetic agents (propofol and remifentanil);Emergence time, defined as the interval from the cessation of all anesthetic agents until the patient responded to verbal command with eye opening.;Length of stay in the post-anesthesia care unit (PACU);Incidence of intraoperative awareness assessed at 24 hours postoperatively.;Incidence of postoperative delirium (POD) assessed at 24 and 48 hours after surgery.;QoR-15 score assessed 30 days postoperatively; | — |
Countries
China
Contacts
Public ContactFu Hailong
The Second Affiliated Hospital of Naval Medical University(Shanghai Changzheng Hospital)
Outcome results
None listed