Transcutaneous Electrical Acupoint Stimulation on Postoperative Dizziness in Hemifacial Spasm Patients

NCT04621578 | Completed

• 1 other identifier: 2020PHB232-01
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Transcutaneous Electrical Acupoint Stimulation; Hemifacial Spasm; Dizziness

Outcome Measures

Primary Outcomes (1)

• 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.

  2 hours after returning to the ward on the day of surgery

Secondary Outcomes (10)

• 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.

• 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.

• 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.

• The use of remedial drugs after surgery

  From the day of surgery to 72 hours 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.

Study Arms (2)

Transcutaneous electrical acupoint stimulation arm

EXPERIMENTAL

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)

Sham stimulation arm

SHAM COMPARATOR

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)

Interventions

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.

Sham stimulation arm; Transcutaneous electrical acupoint stimulation arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status: I-III
• Body mass index (BMI): 18-30
• Diagnosed of hemifacial spasm
• Undergoing microvascular decompression surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Related Publications (3)

• 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.

  PMID: 22168965 BACKGROUND

• 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.

  PMID: 30534153 BACKGROUND

• 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.

  PMID: 31704425 BACKGROUND

MeSH Terms

Conditions

Hemifacial Spasm; Dizziness

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sensation Disorders

Study Officials

• Yi Feng, MD, PhD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Anesthesiology Department

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 9, 2020
• Study Start: December 6, 2020
• Primary Completion: June 25, 2021
• Study Completion: July 30, 2021
• Last Updated: June 1, 2022

Record last verified: 2022-05

Locations

CN (1)