Effect of Transcranial Direct Current Stimulation on Postoperative Delirium in Elderly Patients Undergoing Hip Fracture Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Incidence of postoperative delirium
研究概览
简要总结
To evaluate the efficacy of transcranial direct current stimulation (tDCS) in reducing the incidence of postoperative delirium (POD) in elderly patients undergoing hip fracture surgery.
This single-center, double-blind, randomized controlled trial will enroll participants aged 65 years and older, scheduled for elective hip surgery under spinal anesthesia. Participants will be randomly assigned to either the active-tDCS group or the sham-tDCS group. The active-tDCS group will receive two sessions: one pre-surgery and one post-surgery, with electrodes positioned over the left dorsolateral prefrontal cortex and the right supraorbital area. Each session includes 15-second ramp-up phase at the start, 20 minutes simulation with 2 mA current and 15-second ramp-down phase at the end. The sham-tDCS group will receive two sham procedures with no actual current delivered. Functional brain activity will be monitored before and after each session or sham procedure to assess changes in cortical activation and connectivity using functional near-infrared spectroscopy (fNIRS). The primary outcome measure will be the incidence of POD, assessed using the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM). Secondary outcomes include the severity of delirium, postoperative pain, anxiety, depression, cognitive function, and sleep quality.
详细描述
- Screening The trial staff will review orthopedic inpatient registration lists and elective surgery application forms to identify adults aged 65 years and older scheduled for surgical repair of clinically or radiologically diagnosed femoral neck, intertrochanteric, or subtrochanteric hip fractures. Potential participants will be screened for eligibility based on inclusion and exclusion criteria, which will be assessed through medical record reviews and face-to-face interviews.
- Specific intervention The standard intervention consists of two sessions of tDCS and four sessions of fNIRS. The tDCS sessions will be administered on the day of surgery: the first session will be conducted preoperatively and the second session will take place postoperatively in the PACU. The fNIRS assessments will be performed as part of the monitoring protocol at four designated time points throughout the study.
- Four fNIRS procedures will be conducted in relation to the tDCS interventions: (1) f1 (pre first tDCS) will be conducted before the first tDCS session; (2) f2 (post first tDCS, pre-surgery) will be conducted after the first tDCS session and before surgery; (3) f3 (post-surgery, before second tDCS) will be conducted after surgery and before the second tDCS session; (4) f4 (post second tDCS) will be conducted after the second tDCS session.
The primary outcome measure will be the incidence of POD, assessed using the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM). Secondary outcomes include the severity of delirium, postoperative pain, anxiety, depression, cognitive function, and sleep quality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All participants will remain blinded to their group assignment. Surgeons, anesthesiologists, and ward and operating room nurses will also be blinded to the group allocations and intervention protocols. Additionally, personnel involved in outcome assessment, follow-up, data collection, and data processing will remain blinded to both the intervention protocols and group assignments.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) aged ≥ 65 years; (2) scheduled for elective hip fracture, including femoral head fractures, femoral neck fractures, intertrochanteric or subtrochanteric fractures, femoral head replacement, total hip arthroplasty, or open or closed reduction; (3) platelet count > 80 × 10⁹/L; (4) ASA classification ≤ Grade III; (5) Mini-Mental State Examination (MMSE) scores ≥ 18 points (13); (6) willingness to participate and sign the informed consent form.
排除标准
- •(1) severe mental disorders,(e.g,depression or schizophrenia requiring medication treatment); (2) cranial or scalp injuries; (3) history of symptomatic cerebrovascular disease, including stroke, transient ischemic attack; (4) compound injuries, multiple fractures, periprosthetic fractures, and hip joint revisions; (5) drug or alcohol abuse; (6) severe visual or hearing impairments; (7) history of epilepsy or intracranial metal implants; (8) severe cardiovascular disease history and liver dysfunction, or kidney dysfunction; (9) coagulation abnormalities; (10) severe chronic obstructive pulmonary disease; (11) participation in other clinical studies within the past 3 months.
研究组 & 干预措施
active tDCS
The active-tDCS group will receive a 15-second ramp up phase at the start, 2 mA of tDCS for 20 minutes and a 15-second ramp down phase at the end.
干预措施: active tDCS (Device)
sham tDCS
The sham-tDCS group will only receive the 15-second ramp up phase at the beginning and the 15-second ramp down phase at the end of each session, without the continuous 2 mA current for 20 minutes
干预措施: sham tDCS (Device)
结局指标
主要结局
Incidence of postoperative delirium
时间窗: postoperative days 1, 2 and 3
Delirium will be assessed during the first three postoperative days.The Confusion Assessment Method (CAM) assessment is based on the four key features of delirium: acute onset and fluctuating course, disorganized thinking, inattention, and altered levels of consciousness. Investigators will also consult the medical record or contact a family member, friend, or health care provider who knows the patient well to gather additional information regarding the patient's symptoms.
次要结局
- pain score(postoperative days 1, 2 and 3)
- Subtypes of postoperative delirium.(postoperative days 1, 2 and 3)
研究者
Hua Zheng
Head of the Anesthesiology Department
Huazhong University of Science and Technology