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Transcutaneous Electrical Acupoint Stimulation on Postoperative Dizziness in Hemifacial Spasm Patients

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ClinicalTrials.gov Identifier: NCT04621578
Recruitment Status : Not yet recruiting
First Posted : November 9, 2020
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
Yi Feng, MD, Peking University People's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Transcutaneous Electrical Acupoint Stimulation Hemifacial Spasm Dizziness Device: HANS 100B stimulator (4 conductors, 8 electrodes; Jisheng Co., Nanjing, China) Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Transcutaneous electrical acupoint stimulation arm
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)

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.
Sham Comparator: Sham stimulation arm
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)

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.


Outcome Measures
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Primary Outcome Measures :
  1. The incidence of dizziness at 2 hours after returning to the ward on the day of surgery [ Time Frame: 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 :
  1. Numerical rating scale (NRS) score of postoperative dizziness [ Time Frame: 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.

  2. The incidence and severity of postoperative nausea [ Time Frame: 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.

  3. The number of vomiting after surgery [ Time Frame: In PACU after extubation, and 2 hours, 6 hours, 24 hours, 48 hours, 72 hours after returning to the ward. ]
    Vomiting times after surgery.

  4. The use of remedial drugs after surgery [ Time Frame: From the day of surgery to 72 hours after surgery. ]
    Drug used for anti-emetic or anti-dizziness after surgery.

  5. The incidence and severity of postoperative headache [ Time Frame: 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.

  6. Changes in intraocular pressure before and after surgery [ Time Frame: 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.

  7. Gastrin and 5-Hydroxytryptamine (5-HT) levels in serum and cerebrospinal fluid [ Time Frame: 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.

  8. Postoperative complications monitoring [ Time Frame: From the day of surgery to the day of discharge. ]
    The Clavien-Dindo grading system will be used.

  9. Postoperative duration of stay in hospital [ Time Frame: From the day of surgery to the day of discharge. ]
    The duration when patients stay in hospital after surgery.

  10. Dizziness symptoms 2 weeks after discharge [ Time Frame: 2 weeks after discharge. ]
    Patients will be followed up by telephone 2 weeks after discharge, and the Dizziness Handicap Inventory (DHI) will be used for measurement.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04621578


Contacts
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Contact: Yi Feng, MD, PhD +861088325581 yifeng65@sina.com

Locations
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China, Beijing
Peking University People's Hospital
Beijing, Beijing, China, 100044
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: Yi Feng, MD, PhD Peking University People's Hospital
More Information
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Publications:

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Responsible Party: Yi Feng, MD, Chief of the Anesthesiology Department, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT04621578    
Other Study ID Numbers: 2020PHB232-01
First Posted: November 9, 2020    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemifacial Spasm
Vertigo
Spasm
Dizziness
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
 Sensation Disorders
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Mouth Diseases
Stomatognathic Diseases