Anesthesia, Electroencephalogram, Postoperative Delirium
Conditions
Keywords
Transcutaneous electrical acupoint stimulation, Postoperative delirium, Electroencephalogram
Brief summary
Transcutaneous electrical acupoint stimulation (TEAS) was reported to benefit the patients undergoing surgeries by reducing anesthetics consumption and decreasing anesthesia related adverse effects. Electroencephalogram (EEG) and EEG-related indicators are important indicators reflecting the conscious state of the brain, and different anesthetic drugs and anesthesia depths cause different EEG characteristic changes. The mechanism by which TEAS improves postoperative delirium (POD) is not clear, and whether changes in EEG characteristic parameters is involved needs to be further explored. Therefore, this study aims to observe the effect of TEAS at Neiguan and Shenmen acupoint on POD in elderly patients undergoing abdominal surgery, and to explore the EEG related mechanism underlying TEAS improving POD.
Interventions
OTHERtranscutaneous electrical acupoint stimulation
Electrodes will be attached on the surface of acupoints and electrical stimulation will be given
OTHERControl
Electrodes will be attached on the surface of acupoints but no stimulation will be given
Sponsors
Zhihong LU
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Four or six patients were defined as a block group and the results were sealed in envelopes using computer-generated block randomisation by a researcher not involved in clinical anesthesia. After the patients were enrolled, the study nurse opened the envelope according to the corresponding enrollment number and obtained the group results.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. aged 65 years or older 2. American Society of Anesthesiologists (ASA) classification≤ Grade III 3. Patients scheduled for elective abdominal surgery under general anesthesia 4. Informed consent
Exclusion criteria
1. Patients with severe central nervous system injury or severe cerebrovascular disease 2. Patients with cognitive dysfunction assessed by Confusion Assessment Method before surgery 3. Patients unable to cooperate with studies, such as psychiatric disorders or difficulty in communication 4. Patients with severe hepatic and renal insufficiency 5. Patients with severe respiratory diseases 6. Patients with contraindication for transcutaneous electrical stimulation, such as implanted electrophysiological devices, skin infection and damage at acupuncture points 7. Anticipated duration of anesthesia shorter than 2 hours or postoperative hospital stay shorter than 3 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of delirium by 7 days after surgery | from end of surgery to 7 days after surgery | Delirium will be assessed by 3-minute Diagnostic Interview for Confusion Assessment Method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| electroencephalogram (EEG) alpha band power | From anesthesia induction to the end of surgery | — |
| Maximal decrease of regional cerebral oxygen saturation | From anesthesia induction to the end of surgery | — |
| Incidence of major complications | From end of surgery to discharge from hospital, at an average of 7 days | myocardial ischemia needing intervention, heart failure, respiratory failure, pneumonia, Coma, stroke, altered state of consciousness |
| The numerical rating scale of sleep quality | From end of surgery to 1 day after surgery | The scale is from 0 to 10. 0 is the worst sleep quality, 10 is the best sleep quality |
| The numerical rating scale of pain | From end of surgery to 1 day after surgery | The scale is from 0 to 10. 0 is no pain, 10 is the worst pain |
| The Quality of Recovery-15 Score by 3 days after surgery | From end of surgery to 3 days after surgery | — |
| Incidence of delirium by 1 day after surgery | From end of surgery to 1 day after surgery | — |
| Incidence of delirium by 3 days after surgery | From end of surgery to 3 days after surgery | — |
| opioid consumption for patient controlled analgesia | From end of surgery to 1 day after surgery | the consumption is converted to morphine equivalence |
| number of attempts for patient controlled analgesia | From end of surgery to 1 day after surgery | number of patients pressing the bolus button of the patient controlled analgesia device, indicating that the patient feel pain |
| total sleep time | From end of surgery to 1 day after surgery | — |
Countries
China
Outcome results
None listed