Postoperative acute pain, postoperative delirium (POD), postoperative sleep disturbance (PSD), surgical stress response, inflammatory response
Conditions
Interventions
Dual-modality group:Intraoperative 3M noise-reduction earmuffs plus transcutaneous auricular vagus nerve stimulation (taVNS)
Control group:No earmuffs plus sham taVNS
Noise reduction alone group:Intraoperative 3M noise-reduction earmuffs plus sham taVNS
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >=60 years old, no restriction on sex; 2.Scheduled for elective or urgent hip surgery (femoral neck fracture internal fixation, hemiarthroplasty or total hip arthroplasty), returning to ward postoperatively; 3.ASA classifications II-III; 4.Signed informed consent by the subject or legally authorized representative;
Exclusion criteria
Exclusion criteria: 1.Pre-existing dementia, delirium or severe cognitive impairment (MMSE 3 months with daily opioids); 3.Implanted pacemaker, defibrillator or other electronic devices; second-degree or higher AV block, sick sinus syndrome; 4.Ear deformity, acute infection or skin damage affecting earmuff or electrode placement; 5.Severe hearing impairment (pure-tone average >60 dB); 6.Severe hepatic/renal dysfunction (Child-Pugh C or eGFR 180 or DBP >110 mmHg); 7.Unable to cooperate with postoperative scale assessments;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve (AUC) of resting Numeric Rating Scale (NRS) for postoperative pain within 24 hours; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of postoperative sleep disturbance (PSD) on the first postoperative night;Cumulative rescue analgesic consumption within 24 hours postoperatively;Incidence of postoperative delirium (POD) within 3 days postoperatively;Activity NRS-AUC within 24 hours postoperatively;Serious adverse events (SAE);Adverse events (AE); | — |
Countries
China
Contacts
Public ContactPeng Ke
The First Affiliated Hospital of Soochow University
Outcome results
None listed