Transcutaneous Electrical Acupoint Stimulation on Postoperative Dizziness in Hemifacial Spasm Patients

Study Overview
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Brief Summary
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To observe the prevention and treatment effect of transcutaneous electrical acupoint stimulation (TEAS) on postoperative dizziness in patients with hemifacial spasm undergoing microvascular decompression surgery, and its possible mechanisms.

Detailed Description
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Hemifacial spasm (HFS) is mainly caused by vascular compression on the roots of the VII cranial nerves from the brain stem. Microvascular decompression (MVD) is the exact surgical method for the treatment of HFS, but the incidence of dizziness and postoperative nausea and vomiting (PONV) after MVD is extremely high. Despite the use of dual antiemetic therapy during the operation, the incidence of PONV within 24 hours after MVD is still as high as 66.7%. Medication alone has limited effects on dizziness and PONV treatment after MVD. Meta-analysis shows that transcutaneous electrical acupoint stimulation (TEAS) is associated with the reduction of post-emetic remedies and the incidence of dizziness after general anesthesia, and it can be integrated into the multi-modal therapy of PONV. Therefore, the purpose of our study is to observe the prevention and treatment effect of TEAS on postoperative dizziness in patients with hemifacial spasm undergoing microvascular decompression surgery, and explore its possible mechanisms.

Official Title
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The Effect of Prevention and Treatment of Transcutaneous Electrical Acupoint Stimulation on Postoperative Dizziness in Patients With Hemifacial Spasm Undergoing Microvascular Decompression Surgery: A Randomized Controlled Trial

Conditions
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Transcutaneous Electrical Acupoint Stimulation, Hemifacial Spasm, Dizziness

Intervention / Treatment
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* Device: HANS 100B stimulator (4 conductors, 8 electrodes; Jisheng Co., Nanjing, China)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status: I-III Body mass index (BMI): 18-30 Diagnosed of hemifacial spasm Undergoing microvascular decompression surgery Exclusion Criteria: Pregnant or lactating women Poorly controlled hypertension or poorly controlled diabetes, severe cardiovascular and cerebrovascular diseases and mental illness Cardiac pacemakers Scars on bilateral Neiguan acupoints or on the mastoid area Upper limb nerve injury Raynaud's syndrome Motion sickness or PONV history Eye diseases (glaucoma, cataracts, eye trauma, etc.) or previous eye surgery Participate in other clinical trials

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcutaneous electrical acupoint stimulation arm<br>Patients will be given TEAS treatment at the maximum tolerable intensity at a frequency of 2 Hertz (Hz) after surgery in postanesthesia care unit (PACU), and after returning to the ward. | Device: HANS 100B stimulator (4 conductors, 8 electrodes; Jisheng Co., Nanjing, China)<br>* Stimulation sites: Mastoid area on the contralateral side of the operation, Fengchi acupoint on the contralateral side of the operation, and Neiguan acupoints on both sides. Timing of stimulation: In postanesthesia care unit (PACU) after extubation, 6 hours, 24 hours, 48 hours, and 72 hours after returning to the ward. 30-minutes treatment for each time-point.<br>|
| Sham Comparator: Sham stimulation arm<br>Patients will use the same device, same stimulation site, and be treated at the same time points, but the lead of the device was damaged. Therefore, although the patients can see the stimulator running, there is actually no current passing through. | Device: HANS 100B stimulator (4 conductors, 8 electrodes; Jisheng Co., Nanjing, China)<br>* Stimulation sites: Mastoid area on the contralateral side of the operation, Fengchi acupoint on the contralateral side of the operation, and Neiguan acupoints on both sides. Timing of stimulation: In postanesthesia care unit (PACU) after extubation, 6 hours, 24 hours, 48 hours, and 72 hours after returning to the ward. 30-minutes treatment for each time-point.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of dizziness at 2 hours after returning to the ward on the day of surgery | The patients and their families will be asked to record a diary about their symptoms of dizziness, nausea, vomiting and headache after surgery, and they will be followed up after surgery. | 2 hours after returning to the ward on the day of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical rating scale (NRS) score of postoperative dizziness | A 0-10 point numerical rating scale (NRS) will be used for evaluation of the severity of postoperative dizziness. 0 means no dizziness, and 10 means very severe dizziness. The degree of dizziness worsens as the number increases. | In PACU after extubation, and 2 hours, 6 hours, 24 hours, 48 hours, 72 hours after returning to the ward. | 
| The incidence and severity of postoperative nausea | Nausea severity will be evaluated by a 0-10 point numerical rating scale (NRS). 0 means no nausea, and 10 means very severe nausea. The degree of nausea worsens as the number increases. | In PACU after extubation, and 2 hours, 6 hours, 24 hours, 48 hours, 72 hours after returning to the ward. | 
| The number of vomiting after surgery | Vomiting times after surgery. | In PACU after extubation, and 2 hours, 6 hours, 24 hours, 48 hours, 72 hours after returning to the ward. | 
| The use of remedial drugs after surgery | Drug used for anti-emetic or anti-dizziness after surgery. | From the day of surgery to 72 hours after surgery. | 
| The incidence and severity of postoperative headache | Headache severity will be evaluated by a 0-10 point numerical rating scale (NRS). 0 means no headache, and 10 means very severe headache. The degree of headache worsens as the number increases. | In PACU after extubation, and 2 hours, 6 hours, 24 hours, 48 hours, 72 hours after returning to the ward. | 
| Changes in intraocular pressure before and after surgery | Intraocular pressure will be measured by a non-contact tonometer before and after surgery by the same operator. | Before anesthesia induction, and before leaving PACU on the day of surgery. | 
| Gastrin and 5-Hydroxytryptamine (5-HT) levels in serum and cerebrospinal fluid | Peripheral blood will be collected before and after surgery, and cerebrospinal fluid (CSF) will be collected during the surgery. | The peripheral blood samples will be collected on the day of surgery, and on postoperative day 1. The CSF samples will be collected on the day of surgery. | 
| Postoperative complications monitoring | The Clavien-Dindo grading system will be used. | From the day of surgery to the day of discharge. | 
| Postoperative duration of stay in hospital | The duration when patients stay in hospital after surgery. | From the day of surgery to the day of discharge. | 
| Dizziness symptoms 4 weeks after discharge | Patients will be followed up by telephone 4 weeks after discharge, and the Dizziness Handicap Inventory (DHI) will be used for measurement. | 4 weeks after discharge. |