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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04621578
Other study ID # 2020PHB232-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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