Transcutaneous Electrical Acupoint Stimulation on Postoperative Dizziness in Hemifacial Spasm Patients
Primary Purpose
Transcutaneous Electrical Acupoint Stimulation, Hemifacial Spasm, Dizziness
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
HANS 100B stimulator (4 conductors, 8 electrodes; Jisheng Co., Nanjing, China)
Sponsored by
About this trial
This is an interventional treatment trial for Transcutaneous Electrical Acupoint Stimulation
Eligibility 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
Sites / Locations
- Peking University People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Transcutaneous electrical acupoint stimulation arm
Sham stimulation arm
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
The number of vomiting after surgery
Vomiting times after surgery.
The use of remedial drugs after surgery
Drug used for anti-emetic or anti-dizziness 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.
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.
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.
Postoperative complications monitoring
The Clavien-Dindo grading system will be used.
Postoperative duration of stay in hospital
The duration when patients stay in hospital after surgery.
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.
Full Information
NCT ID
NCT04621578
First Posted
November 3, 2020
Last Updated
May 27, 2022
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04621578
Brief Title
Transcutaneous Electrical Acupoint Stimulation on Postoperative Dizziness in Hemifacial Spasm Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 6, 2020 (Actual)
Primary Completion Date
June 25, 2021 (Actual)
Study Completion Date
July 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transcutaneous Electrical Acupoint Stimulation, Hemifacial Spasm, Dizziness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transcutaneous electrical acupoint stimulation arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham stimulation arm
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
HANS 100B stimulator (4 conductors, 8 electrodes; Jisheng Co., Nanjing, China)
Intervention Description
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 Outcome Measure Information:
Title
The incidence of dizziness at 2 hours after returning to the ward on the day of surgery
Description
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.
Time Frame
2 hours after returning to the ward on the day of surgery
Secondary Outcome Measure Information:
Title
Numerical rating scale (NRS) score of postoperative dizziness
Description
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.
Time Frame
In PACU after extubation, and 2 hours, 6 hours, 24 hours, 48 hours, 72 hours after returning to the ward.
Title
The incidence and severity of postoperative nausea
Description
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.
Time Frame
In PACU after extubation, and 2 hours, 6 hours, 24 hours, 48 hours, 72 hours after returning to the ward.
Title
The number of vomiting after surgery
Description
Vomiting times after surgery.
Time Frame
In PACU after extubation, and 2 hours, 6 hours, 24 hours, 48 hours, 72 hours after returning to the ward.
Title
The use of remedial drugs after surgery
Description
Drug used for anti-emetic or anti-dizziness after surgery.
Time Frame
From the day of surgery to 72 hours after surgery.
Title
The incidence and severity of postoperative headache
Description
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.
Time Frame
In PACU after extubation, and 2 hours, 6 hours, 24 hours, 48 hours, 72 hours after returning to the ward.
Title
Changes in intraocular pressure before and after surgery
Description
Intraocular pressure will be measured by a non-contact tonometer before and after surgery by the same operator.
Time Frame
Before anesthesia induction, and before leaving PACU on the day of surgery.
Title
Gastrin and 5-Hydroxytryptamine (5-HT) levels in serum and cerebrospinal fluid
Description
Peripheral blood will be collected before and after surgery, and cerebrospinal fluid (CSF) will be collected during the surgery.
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.
Title
Postoperative complications monitoring
Description
The Clavien-Dindo grading system will be used.
Time Frame
From the day of surgery to the day of discharge.
Title
Postoperative duration of stay in hospital
Description
The duration when patients stay in hospital after surgery.
Time Frame
From the day of surgery to the day of discharge.
Title
Dizziness symptoms 4 weeks after discharge
Description
Patients will be followed up by telephone 4 weeks after discharge, and the Dizziness Handicap Inventory (DHI) will be used for measurement.
Time Frame
4 weeks after discharge.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Feng, MD, PhD
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
22168965
Citation
Miller LE, Miller VM. Safety and effectiveness of microvascular decompression for treatment of hemifacial spasm: a systematic review. Br J Neurosurg. 2012 Aug;26(4):438-44. doi: 10.3109/02688697.2011.641613. Epub 2011 Dec 15.
Results Reference
background
PubMed Identifier
30534153
Citation
Thongrong C, Chullabodhi P, Kasemsiri P, Kitkhuandee A, Plailaharn N, Sabangban L, Jimarsa T. Effects of Intraoperative Dexamethasone and Ondansetron on Postoperative Nausea and Vomiting in Microvascular Decompression Surgery: A Randomized Controlled Study. Anesthesiol Res Pract. 2018 Nov 11;2018:6297362. doi: 10.1155/2018/6297362. eCollection 2018.
Results Reference
background
PubMed Identifier
31704425
Citation
Chen J, Tu Q, Miao S, Zhou Z, Hu S. Transcutaneous electrical acupoint stimulation for preventing postoperative nausea and vomiting after general anesthesia: A meta-analysis of randomized controlled trials. Int J Surg. 2020 Jan;73:57-64. doi: 10.1016/j.ijsu.2019.10.036. Epub 2019 Nov 6.
Results Reference
background
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Transcutaneous Electrical Acupoint Stimulation on Postoperative Dizziness in Hemifacial Spasm Patients
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