The incidence of postoperative anxiety in surgery ranges from 4.1% to 79.6% , and among patients undergoing intraspinal tumor resection surgery, the incidence of postoperative anxiety is as high as 46.7%.Adverse effects induced by anxiety include insomnia, exacerbated pain, impaired wound healing and immune function, increased risk of adverse cardiovascular events, and postoperative cognitive dysfunction. These may lead to postoperative depression and chronic pain, significantly delaying patient recovery.
The goal of this study is to investigate the effects of intraoperative transcranial alternating current stimulation on postoperative anxiety in adult patients undergoing intraspinal tumor resection. It will also evaluate the safety of the transcranial alternating current stimulation.
This study will enroll adult patients undergoing elective intraspinal tumor resection surgery. The study will compare the transcranial alternating current stimulation with a sham stimulation to see whether the intervention can reduce the incidence of postoperative anxiety. The trial will also compare the anxiety scores, the incidence of delirium, pain scores, frial scores, sleep quality scores, recovery quality scores and adverse events between intervention and control groups. We also plan to compare the electroencephalography parameters and serum level of substance P to investigate the potential mechanism.
Age 18 to 65 years old
Scheduled for elective intraspinal tumor resection under general anesthesia
American Society of Anesthesiologists physical status I-III
Able to understand and complete the Hospital Anxiety and Depression Scale and other study-related questionnaires
Preoperative HADS-A score ≥ 8
History of psychiatric disorders (e.g., depression, psychosis) or use of psychotropic medications within the past 3 months
History of neurological diseases (e.g., epilepsy, stroke, dementia) or severe head trauma
Contraindications to transcranial alternating current stimulation, including metallic implants in the head, skull defects, or a history of seizures
Parallel
Transcranial Alternating Current Stimulation
DeviceThis study uses intraoperative transcranial alternating current stimulation (tACS) delivered via a non-invasive, portable electrical stimulation device. The intervention consists of 10 Hz alternating current at 2 mA intensity, applied bilaterally over the prefrontal cortex (F3/F4 electrode positions) for 20 minutes immediately following anesthesia induction during elective intraspinal tumor resection. The device is calibrated to deliver a consistent, low-level current that does not interfere with standard anesthesia or surgical procedures.
Sham (No Treatment)
DeviceWear the transcranial electrical stimulator without applying electric current
Incidence of Postoperative Anxiety Within 3 Days After Surgery
The primary outcome is the incidence of postoperative anxiety, defined as a Hospital Anxiety and Depression Scale-Anxiety score ≥ 8 at any time point on the day of surgery or postoperative days 1, 2, or 3. Participants will be assessed by trained evaluators blinded to group allocation.
Severity of postoperative anxiety
Anxiety severity will be evaluated using the Hospital Anxiety and Depression Scale-Anxiety score. Assessments will be performed at 1 day before surgery, the day of surgery, postoperative days 1, 2, 3, and 3 months after surgery.
Postoperative delirium assessed by 3-minute Diagnostic Confusion Assessment Method score
Postoperative delirium will be evaluated using the 3-minute Diagnostic Confusion Assessment Method score. Assessments will be performed in the morning (8:00-10:00) and afternoon (16:00-18:00) on the day of surgery and postoperative days 1, 2, 3.
Postoperative pain intensity assessed by Numeric Rating Scale score
Postoperative pain intensity will be evaluated using the Numeric Rating Scale score at 1 day before surgery and at 6, 24, 48, and 72 hours after surgery.
Frailty status assessed by Fatigue, Resistance, Ambulation, Illnesses, and Loss of weight score
Frailty will be evaluated using the Fatigue, Resistance, Ambulation, Illnesses, and Loss of weight score at 1 day before surgery, postoperative days 1, 2, 3, and 3 months after surgery.
Serum substance P concentration
Serum substance P levels will be measured by enzyme-linked immunosorbent assay (ELISA) at baseline (2 days before surgery), and at 2 days after surgery.
Changes in Electroencephalographic Oscillations
Resting-state electroencephalography will be recorded at baseline (2 days before surgery), and at 2 days after surgery. Changes in power spectral density (delta, theta, alpha, beta bands) and functional connectivity will be analyzed. The association between these changes and postoperative anxiety outcomes will be explored.
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