Postoperative Complications, Postoperative Nausea and Vomiting, Postoperative Infection, Postoperative Delirium, Postoperative Pneumonia, Deep Vein Thrombosis, Postoperative Retention of Urine, Postoperative Recovery
Conditions
Keywords
Acupoint Stimulation, postoperative recovery, Postoperative Complications, Peri-operation
Brief summary
This study investigates electrical acupoint stimulation (EAS) administered in peri-operation for improving postoperative recovery in elder patients, who accept knee arthroplasty. the surgery cause to change of stress response, which might be associated with postoperative recovery of patient Totally, three groups are created, 1/3 participants receive transcutaneous electrical acupoint stimulation, 1/3 participants receive electroacupuncture, the rest 1/3 will use sham transcutaneous electrical acupoint stimulation.
Detailed description
Theoretically, the application of electrical acupoint stimulation (EAS) base on the theory of traditional Chinese medicine. It deems that a surgery might consume Qi, then cause to imbalance of Qi and Blood, especially in elder patients. Besides, surgery lead to change of stress response (hormones). The EAS administration intra-operatively perhaps be beneficial to recovery of patients, reduce the incidence of postoperative complications. The main possible mechanism was stress response regulation. The hypothesis is that the EAS improve postoperative recovery of patient through regulating stress response.
Interventions
DEVICETranscutaneous Electrical Acupoint Stimulation
The intervention will be administered by electrical acupoint machine, the brand is Great Wall.
DEVICEElectroacupuncture
The intervention will be administered by electrical acupoint machine, the brand is Great Wall.
The intervention will be administered by transcutaneous electrical acupoint machine, even no truly actualized.
Sponsors
Shandong University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The intervention administered randomly to the participants. The participants, care providers, investigator, outcomes assessor done their job, separately. The blind will be controlled by a assigned investigator.
Intervention model description
The participants divided into 3 groups randomized, one group receive transcutaneous electrical acupoint stimulation, one group receive electroacupuncture, the third group only connect to acupoints without stimulation.
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Agree to sign the contract * The patients receive total hip or knee arthroplasty * Epidural anesthesia administered
Exclusion criteria
* The patients' age out of range setting * Forbidden to the administration of transcutaneous electrical acupoint stimulation * Communication disorder * The patients who had medical history of cerebral vascular diseases, deep vein thrombosis, urinary retention, nausea and vomiting. * The patients who attended another trial in the past three months * Emergency surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The postoperative recovery | 7 days | Record the postoperative recovery after surgery through quality of recovery-40 questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The adverse event | 7 days | Record all the adverse events appeared during the entire trail, which might cause to skin rash, allergic reaction, et al. |
| The level of stress response | up to 7 days | Assess the level of preoperative stress response at 1, 3, 7 days after operation. It mainly include Adrenocorticotropic Hormone (ACTH), Cortisol (COR), Adrenaline (E), norepinephrine (NE). All measures unit is pg/ml. |
| Postoperative complications | 7 days | Record the incidence of any postoperative complications during 7 days |
| The level of inflammatory response by TNF-a, IL-1, IL-6, IL-10 | up to 7 days | Assess the level of perioperative inflammatory response at 1, 3, 7 days after operation. It mainly include Tumor Necrosis Factor-a (TNF-a), Interleukins-1 (IL-1), Interleukins-6 (IL-6), Interleukins-10 (IL-10). All measures unit is ng/ml. |
| The level of inflammatory response by C-reactive protein | up to 7 days | Assess the level of perioperative inflammatory response at 1, 3, 7 days after operation through C-reactive protein. the unit is mg/L. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Age in years | 1 day | Once patients enrolled, the age (years) need to be recorded ahead of operation. |
| ASA classification status | 1 day | Once patients enrolled, the ASA condition need to be recorded ahead of operation depend on the ASA classification. |
| Gender | 1 day | Once patients enrolled, the gender need to be recorded ahead of operation. |
| Weight in kilograms | 1 day | Once patients enrolled, the weight (kilograms) need to be recorded ahead of operation. |
| Height in meters | 1 day | Once patients enrolled, the height (meters) need to be recorded ahead of operation. |
| BMI in kg/m^2 | 1 day | Once patients enrolled, the BMI (weight and height will be combined to report BMI in kg/m\^2) will be reported base on weight and height ahead of operation. |
Countries
China
Contacts
Primary Contactzhang weiliang, MD
Backup ContactSu Fan, MD
Outcome results
None listed