Transcutaneous Electrical Acupoint Stimulation on Postoperative Dizziness in Hemifacial Spasm Patients
- Conditions
- Transcutaneous Electrical Acupoint StimulationHemifacial SpasmDizziness
- Interventions
- Device: HANS 100B stimulator (4 conductors, 8 electrodes; Jisheng Co., Nanjing, China)
- Registration Number
- NCT04621578
- Lead Sponsor
- Peking University People's Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
- American Society of Anesthesiologists (ASA) physical status: I-III
- Body mass index (BMI): 18-30
- Diagnosed of hemifacial spasm
- Undergoing microvascular decompression surgery
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transcutaneous electrical acupoint stimulation arm HANS 100B stimulator (4 conductors, 8 electrodes; Jisheng Co., Nanjing, China) 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. Sham stimulation arm HANS 100B stimulator (4 conductors, 8 electrodes; Jisheng Co., Nanjing, China) 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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.
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.
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.
Postoperative complications monitoring From the day of surgery to the day of discharge. The Clavien-Dindo grading system will be used.
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.
Trial Locations
- Locations (1)
Peking University People's Hospital
🇨🇳Beijing, Beijing, China