Transcutaneous Electrical Acupoint Stimulation on Postoperative Dizziness in Hemifacial Spasm Patients

Dizziness Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04621578
• Other study ID #: 2020PHB232-01
• Status: Completed
• Phase: N/A
• Start date: December 6, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: May 2022
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: July 30, 2021
• Est. primary completion date: June 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dizziness
• Hemifacial Spasm
• Spasm
• Transcutaneous Electrical Acupoint Stimulation
• Vertigo

Intervention

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.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	In PACU after extubation, and 2 hours, 6 hours, 24 hours, 48 hours, 72 hours after returning to the ward.
Secondary	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.	In PACU after extubation, and 2 hours, 6 hours, 24 hours, 48 hours, 72 hours after returning to the ward.
Secondary	The number of vomiting after surgery	Vomiting times after surgery.	In PACU after extubation, and 2 hours, 6 hours, 24 hours, 48 hours, 72 hours after returning to the ward.
Secondary	The use of remedial drugs after surgery	Drug used for anti-emetic or anti-dizziness after surgery.	From the day of surgery to 72 hours after surgery.
Secondary	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.	In PACU after extubation, and 2 hours, 6 hours, 24 hours, 48 hours, 72 hours after returning to the ward.
Secondary	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.	Before anesthesia induction, and before leaving PACU on the day of surgery.
Secondary	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.	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.
Secondary	Postoperative complications monitoring	The Clavien-Dindo grading system will be used.	From the day of surgery to the day of discharge.
Secondary	Postoperative duration of stay in hospital	The duration when patients stay in hospital after surgery.	From the day of surgery to the day of discharge.
Secondary	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.	4 weeks after discharge.