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| Name | Class |
|---|---|
| Jinhua Central Hospital | OTHER |
| Huzhou Central Hospital | OTHER |
| The First People's Hospital of Huzhou | OTHER |
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The goal of this clinical trial is to evaluate the effects of transcutaneous electrical acupoint stimulation (TEAS) combined with triple antiemetics for postoperative nausea and vomiting (PONV) in high-risk patients.
The primary question it seeks to answer is:
Does TEAS combined with triple antiemetics further reduce the incidence of PONV in high-risk subjects? Researchers will compare active TEAS with sham stimulation to determine whether the addition of TEAS to dexamethasone, palonosetron, and droperidol lowers the PONV rate beyond that achieved by the triple-drug prophylaxis alone.
780 female patients, aged between 18 to 65 y, who are scheduled for elective laparoscopic surgery requiring general anesthesia, will be randomly allocated to acustimulation group (Group TEAS), or the control group.
In Group TEAS, a surface electrode will be applied to the P6 and L14 acupoint 30 min before induction. An operator will set electric stimulating current at 1mA with frequency at 2 Hz, and gradually increased the current intensity to a little below discomfort threshold. The stimulation will be maintained until the patient is discharged from the operation. In the control group the same protocol was applied for percutaneous acupoint electrical stimulation, initiated before anesthesia induction with the minimum perceptible current (MPC) and terminated after 1 minute.
A standardized anesthetic protocol will be followed. In all groups, dexamethasone 5mg and palonosetron 0.25mg i.v. will be given after induction, and droperidol 1.25 mg i.v. will be given during the abdominal closure. After surgery, metoclopramide 10mg i.v. will be administered as a rescue therapy to any patient who experiences an episode of moderate or severe nausea, an episode of vomiting, and requests rescue medication.
The patients shall be unaware of the group assignments. An anesthesiologist, who are trained for the study and blinded to the randomization, will collect the data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The TEAS group | Experimental | The TEAS group,Nei-guan (PC6) and He-gu (LI4) were stimulated by a transcutaneous acupoint electrical stimulation instrument approximately 30 minutes before anesthesia induction until the patient is discharged from the operating room. |
|
| The control group | Sham Comparator | The same protocol was applied for percutaneous acupoint electrical stimulation, initiated before anesthesia induction with the minimum perceptible current (MPC) and terminated after 1 minute. To ensure complete blinding, both groups were covered with opaque sheets over the percutaneous acupoint electrical stimulation device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcutaneous electrical acupoint stimulation | Device | Using the Huatuo brand electronic acupuncture therapy device (Model: SDZ-â…¢, produced by Suzhou Medical Equipment Co., Ltd., China), bilateral upper limb acupoints P6+L14 were selected. Approximately 30 minutes before anesthesia induction, the electrodes were connected with the initial current set at 1 milliampere and frequency at 2/100 Hz. The current intensity was gradually increased until the patient felt pain or reached the discomfort threshold (ranging between 6 to 10 mA), and the stimulation was maintained until the patient was discharged from the PACU. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Nausea,Retching and Vomiting within 24 hours after operation. | The number of episodes of nausea, retching and vomiting within 24 hours after operation | 2 hours post-operation, 6 hours post-operation, 24 hours post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Postoperative Nausea in 48 h Postoperatively | Nausea score: The severity of PON was measured using a visual analog scale (VAS), with 0 indicating no symptoms and 10 representing the most severe imaginable symptoms. | 2 hours post-operation, 6 hours post-operation, 24 hours post-operation, 48 hours post-operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diansan Su, PhD | Contact | +8618616514088 | diansansu@yahoo.com | |
| Dongdong Tian | Contact | +8615924165551 | tddcomeon@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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Both acupoint stimulation and placebo treatment will be administered by the same investigator, who will take no part in anesthesia management or data collection. To maintain blinding, an opaque drape will be placed over the TEAS unit in both groups. All participants will be informed that they may or may not feel a tingling sensation at the wrists while the device is operating. Follow-up and data collection will be performed by a separate investigator who is uninvolved in routine anesthesia care and blinded to group allocation.
|
| Sham transcutaneous electrical acupoint stimulation | Device | The same protocol was applied for percutaneous acupoint electrical stimulation, initiated before anesthesia induction with the minimum perceptible current (MPC) and terminated after 1 minute. |
|
| triple antiemetic drugs | Drug | Dexamethasone 5mg and palonosetron 0.25mg i.v. will be given after induction, and droperidol 1.25 mg i.v. will be given during the abdominal closure. |
|
| Number of Participants Experiencing Postoperative Vomiting in 48 h Postoperatively | including retching and vomiting | 2 hours post-operation, 6 hours post-operation, 24 hours post-operation, 48 hours post-operation |
| Need of Postoperative Metoclopramide | Need of Postoperative Metoclopramide | 2 hours post-operation, 6 hours post-operation, 24 hours post-operation, 48 hours post-operation |
| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D010051 | Ovarian Neoplasms |
| D042882 | Gallstones |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D041761 | Cholecystolithiasis |
| D005705 | Gallbladder Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
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