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This is a single center, randomized, double-blinded, controlled clinical trial.The purpose of this study is to compare the effect of TEAS pretreatment with single acupoint or two acupoints for postoperative nausea and vomiting in patients undergoing laparoscopic operation.
Patients were randomly assigned to four groups, receiving TEAS 30 minutes before induction.The stimulation was applied until the end of the operation. Postoperative nausea and vomiting was recorded 30 minute, 2 hour, 6 hour and 24 hour after the operation. The adverse events were recorded as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| shuangxuezu | Experimental | Patients were given 30min of TEAS before induction until the end of the operation at two acupoints. |
|
| neiguanxuezu | Experimental | Patients were given TEAS at neiguan acupoint. |
|
| zusanlixuezu | Experimental | Patients were given TEAS at Zusanli acupoint. |
|
| duizhaozu | Sham Comparator | Patients were not given TEAS at two acupoints. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEAS (transcutaneous electrical acupoint stimulation) | Device | Electric stimulation was given through electrode attached to specific acupoints |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of postoperative nausea and vomiting | within 24 hours after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of other postoperative complications | 30minutes, 2hours, 6hours and 24 hours after operation | |
| Postoperative nausea and vomiting(PONV) score | 30minutes, 2hours, 6hours and 24 hours after operation |
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Inclusion Criteria:
Exclusion Criteria:
ASA IV
Hypertension that is not controlled
Severe hepatic or renal dysfunction
Ever had received electrical stimulation treatment
Severe systemic infection
With contraindications to the use of TEAS, such as skin damage or infection at the acupoints
For any reason one can not cope with the studies, such as the following:
language comprehension, mental illness
Participate in the other clinical trial 3 month before the enrollment
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haifeng Duan | Contact | 15091626182 | 875939063@qq.com | |
| Zhihong Lu, M.D.;Ph D | Contact | 029-84775343 | deerlu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lizhe Xiong, M.D.;Ph D | Air Force Military Medical University, China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital, Fourth Military Medical University | Xi'an | Shaanxi | 710032 | China |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| Visual Analogue Scale (VAS) pain score in PACU | 30 minutes after operation |
| Change of concentration of serum 5-HT | intraoperative |
| Change of concentration of serum dopamine | intraoperative |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |