Clinical trial NCT04621578: 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
Overall status: COMPLETED
Phase: NA
Conditions: Transcutaneous Electrical Acupoint Stimulation
Hemifacial Spasm
Dizziness
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The incidence of dizziness at 2 hours after returning to the ward on the day of surgery
timeFrame: 2 hours after returning to the ward on the day of surgery
Secondary outcomes:
measure: Numerical rating scale (NRS) score of postoperative dizziness
timeFrame: In PACU after extubation, and 2 hours, 6 hours, 24 hours, 48 hours, 72 hours after returning to the ward.
measure: The incidence and severity of postoperative nausea
timeFrame: In PACU after extubation, and 2 hours, 6 hours, 24 hours, 48 hours, 72 hours after returning to the ward.
measure: The number of vomiting after surgery
timeFrame: In PACU after extubation, and 2 hours, 6 hours, 24 hours, 48 hours, 72 hours after returning to the ward.
measure: The use of remedial drugs after surgery
timeFrame: From the day of surgery to 72 hours after surgery.
measure: The incidence and severity of postoperative headache
timeFrame: In PACU after extubation, and 2 hours, 6 hours, 24 hours, 48 hours, 72 hours after returning to the ward.
measure: Changes in intraocular pressure before and after surgery
timeFrame: Before anesthesia induction, and before leaving PACU on the day of surgery.
measure: Gastrin and 5-Hydroxytryptamine (5-HT) levels in serum and cerebrospinal fluid
timeFrame: 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.
measure: Postoperative complications monitoring
timeFrame: From the day of surgery to the day of discharge.
measure: Postoperative duration of stay in hospital
timeFrame: From the day of surgery to the day of discharge.
measure: Dizziness symptoms 4 weeks after discharge
timeFrame: 4 weeks after discharge.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Yi Feng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.