Postoperative Delirium
Conditions
Keywords
Elderly patients, postoperative delirium, gastrointestinal surgery, Auricular vagus nerve stimulation, Transcutaneous electrical acupoint stimulation
Brief summary
The aim of this clinical trial is to study the effect of transcutaneous electrical acupoint stimulation combined with auricular vagus nerve stimulation on postoperative delirium in elderly patients undergoing gastrointestinal surgery. The study aims to answer the following main questions 1. whether it reduces the expression of inflammatory factors in the acute postoperative period 2. whether it can reduce the incidence of postoperative delirium
Detailed description
Existing clinical studies have shown that TEAS has demonstrated value in preventing postoperative delirium (POD). Currently, taVNS is commonly used clinically to improve patients' cognitive dysfunction (POCD), and POD is often considered a precursor to the development of POCD. However, no one has yet used the two in combination, so this study aimed to combine the two to investigate their potential benefits in preventing POD.
Interventions
DEVICETranscutaneous electrical acupoint stimulation
Before induction of anaesthesia, electrodes were attached to selected acupoints and energised for 30 min, with the electrical stimulation parameter of dispersed dense wave (2/100 Hz), and the current intensity was based on the maximum current intensity that could be tolerated by the patient.
DEVICETranscutaneous electrical acupoint stimulation combined with auricular vagus nerve stimulation
Before anaesthesia induction, the electrodes were attached to the selected acupoints and energized for 30 min, with the electrical stimulation parameters of dispersed dense wave (2/100Hz), and the current intensity was based on the maximum current intensity that the patient could tolerate. At the same time, the left ear auricular region was stimulated with a fasciculus nerve stimulator, the electrical stimulation parameters were: pulse width of 250 μs, pulse frequency of 20Hz, every 30s on, 30s off, and then 30s on again, the current intensity was based on the maximum current intensity that the patient could tolerate, for 30min.
Sponsors
Affiliated Hospital of Nantong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged ≥65 years; 2. Body mass index (BMI) 18-30 kg/m²; 3. American Society of Anesthesiologists (ASA) physical status classification I-III; 4. Patients scheduled for elective laparoscopic gastrointestinal surgery; 5. Willingness to provide written informed consent and comply with the treatment regimen; 6. Absence of severe organic diseases, psychiatric disorders, or preoperative delirium.
Exclusion criteria
1. Preoperative Mini-Mental State Examination (MMSE) score \<20; 2. Electrocardiographic evidence of severe bradycardia (heart rate \<50 beats per minute); 3. Presence of skin lesions or infections at the electrical stimulation site; 4. History of preoperative chemotherapy or radiotherapy; 5. Concomitant severe organic diseases with compromised tolerance to interventions; 6. Prior exposure to Transcutaneous Electrical Acupoint Stimulation (TEAS) or transcutaneous auricular vagus nerve stimulation (taVNS) with documented insensitivity; 7. Inability to communicate normally, dementia, hearing impairment, or severe psychiatric disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative delirium | The first to third days after surgery | Whether delirium occurred after surgery（by 3D-CAM） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IL-6 andTNF-α level | before operation（Before anesthesia），the end of the operation（Immediately after the sewing is finished） | the level of IL-6 andTNF-α in the participant's serum（by ELISA） |
| VAS pain score | The first to third days after surgery | Assessed with a VAS score scale, the highest is 10 and the lowest is 0, the higher the more severe the pain |
| Early activities | Post-operative period until discharge（in about a week） | The first time to be able to get out of bed and move |
| Time to first postoperative anal defecation | Post-operative period until discharge（In about a week） | Time to first postoperative anal defecation |
| Adverse events | The first to third days after surgery | Nausea and vomiting, sore throat, itching |
Countries
China
Outcome results
None listed