Skip to main content
OpenTrials
Completed

NCT Number: NCT04621578

Transcutaneous Electrical Acupoint Stimulation on Postoperative Dizziness in Hemifacial Spasm Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Transcutaneous Electrical Acupoint Stimulation Dizziness Hemifacial Spasm Mouth Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Spasm Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HANS 100B stimulator (4 conductors, 8 electrodes; Jisheng Co., Nanjing, China)

Device

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.

Primary outcomes

  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 outcomes

  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 4 weeks after discharge

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 9, 2020
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.