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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
102
This 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.
Wear the transcranial electrical stimulator without applying electric current
Xuanwu Hospital
Beijing, China
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.
Time frame: From the day of surgery up to postoperative day 3
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.
Time frame: 1 day before surgery, 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.
Time frame: 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.
Time frame: 1 day before surgery, 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.
Time frame: 1 day before surgery, postoperative days 1, 2, 3, and 3 months after surgery
Sleep quality assessed by Pittsburgh Sleep Quality Index score
Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index score at 1 day before surgery, the day of surgery, postoperative days 1, 2, 3, and 3 months after surgery.
Time frame: 1 day before surgery, day of surgery, postoperative days 1, 2, 3, and 3 months after surgery
Quality of recovery assessed by 15-item Quality of Recovery score
Postoperative recovery quality will be evaluated using the 15-item Quality of Recovery score on the day of surgery, postoperative days 1, 2, 3, and 1 month after surgery.
Time frame: Day of surgery, postoperative days 1, 2, 3, and 1 month after surgery
Time to ambulation
Time to first ambulation after surgery will be recorded and compared between groups.
Time frame: Day of surgery, postoperative days 1, 2, 3
Length of hospital stay
Total length of hospital stay will be recorded and compared between groups.
Time frame: From the day when patient hospitalization to 3 weeks after surgery
Incidence of adverse events, complications, and 30-day all-cause mortality
Incidence of adverse events, complications, and 30-day all-cause mortality will be monitored and compared between groups.
Time frame: Up to 30 days after surgery
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