Therapeutic (Nonsurgical) and Rehabilitative Anesthesiology Devices Associated With Adverse Incidents
Conditions
Keywords
Electroacupuncture, Analgesia, Anesthesia, Nasal septoplasty, Mammaplasty
Brief summary
The purpose of this study is to verify the intraoperative analgesia of electroacupuncture in patients undergoing selective nasal sinus surgery and mammaplasty.
Detailed description
Acupuncture therapy has been proved helpful in the patients suffering from various pain problems. And it is reported to be able to reduce the intraoperative anesthetic requirement. However, so far there is few evidence from randomized controlled studies to confirm the assistant anesthetic effect of acupuncture. Electroacupuncture (EA) is a modern non-invasive technique of traditional acupuncture. Compared to traditional acupuncture, EA is more practicable, more easily to be accepted by patients and operated by physicians. Nasal sinus surgery and mammaplasty, especially breast augmentation, mostly belong to the scope of day surgeries, which demand a rapid, smooth recovery from anesthesia with minimum adverse side effects (e.g.: pain, PONV, etc).
Interventions
PROCEDUREnon-electroacupuncture
The same procedure as electroacupuncture except stimulation
PROCEDUREElectroacupuncture
Electrodes are applied to bilateral Hegu(L14) acupoints at the time of 1h before operation, and connected to Hwato Electronic Acupuncture Treatment Instrument (Model No. SDZ-V, Suzhou Medical Appliances Co., Ltd., Suzhou, China). The acupoints are stimulated at an intensity of 3\ 6 mA and a frequency of 2/30 Hz for 30 min. The highest intensity will be chosen at which the patient can tolerate.
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
29 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* selective nasal sinus surgery * selective mammaplasty * patients who accept the follow-up and sign the informed consent * ASA 1\ 2
Exclusion criteria
* emergent surgery * pregnant or breast-feeding women * coagulopathy * history of gastrointestinal ulcer * liver or renal dysfunction * enrollment in other clinical trials at the same time not reaching the primary endpoint and probably interference the present trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the mean infusion rate of intraoperative remifentanil and propofol | during operation | To investigate the operative time and total volume of remifentanil and propofol used during operation, and then calculate the mean infusion rate. To assess whether intraoperative requirements for anesthetic drugs could be reduced by EA pretreatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue scale | post-operative 4h, 8h, 24h and 48h | To assess whether EA pretreatment could help in alleviating acute post-operative pain. |
| Extubation time | postoperation | To investigate the time from the end of propofol and remifentanil infusion to extubation. To assess whether EA pretreatment could shorten the extubation time. |
Other
| Measure | Time frame | Description |
|---|---|---|
| plasma β-endorphin and cortisol concentration | preoperation, 0h and 24h postoperation | To assess whether EA pretreatment could increase the plasma levels of β-endorphin and cortisol. |
| Ramsay score | post-operative 4h, 8h, 24h, 48h | To assess the effect of EA pretreatment on post-operative Ramsay scores. |
| incidence of post-operative nausea and vomiting (PONV) | within post-operative 24 hours | To assess the effect of EA pretreatment on PONV. |
Countries
China
Outcome results
None listed