Dizziness, Hemifacial Spasm, Transcutaneous Electrical Acupoint Stimulation
Conditions
Brief summary
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
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.
Interventions
DEVICEHANS 100B stimulator (4 conductors, 8 electrodes; Jisheng Co., Nanjing, China)
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.
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of dizziness at 2 hours after returning to the ward on the day of surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence and severity of postoperative nausea | In PACU after extubation, and 2 hours, 6 hours, 24 hours, 48 hours, 72 hours after returning to the ward. | 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. |
| The number of vomiting after surgery | In PACU after extubation, and 2 hours, 6 hours, 24 hours, 48 hours, 72 hours after returning to the ward. | Vomiting times after surgery. |
| The use of remedial drugs after surgery | From the day of surgery to 72 hours after surgery. | Drug used for anti-emetic or anti-dizziness after surgery. |
| The incidence and severity of postoperative headache | In PACU after extubation, and 2 hours, 6 hours, 24 hours, 48 hours, 72 hours after returning to the ward. | 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. |
| Numerical rating scale (NRS) score of postoperative dizziness | In PACU after extubation, and 2 hours, 6 hours, 24 hours, 48 hours, 72 hours after returning to the ward. | 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. |
| Gastrin and 5-Hydroxytryptamine (5-HT) levels in serum and cerebrospinal fluid | 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. | Peripheral blood will be collected before and after surgery, and cerebrospinal fluid (CSF) will be collected during the surgery. |
| Postoperative complications monitoring | From the day of surgery to the day of discharge. | The Clavien-Dindo grading system will be used. |
| Postoperative duration of stay in hospital | From the day of surgery to the day of discharge. | The duration when patients stay in hospital after surgery. |
| Dizziness symptoms 4 weeks after discharge | 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. |
| Changes in intraocular pressure before and after surgery | Before anesthesia induction, and before leaving PACU on the day of surgery. | Intraocular pressure will be measured by a non-contact tonometer before and after surgery by the same operator. |
Countries
China
Outcome results
None listed