An interventional study of HANS 100B stimulator (4 conductors, 8 electrodes; Jisheng Co., Nanjing, China) in Transcutaneous Electrical Acupoint Stimulation, Hemifacial Spasm and Dizziness, sponsored by Peking University People's Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-06-01.
Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment
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.
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.
23 studies on the registry are indexed under Hemifacial Spasm; 3 are open to participants now.
This study's enrollment of 86 is above the median of 61 across 11 interventional studies indexed under Hemifacial Spasm.
Browse Hemifacial Spasm studies →Peking University People's Hospital is the lead sponsor of 609 studies on the registry; 247 are open to participants now.
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Exclusion Criteria:
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The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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.
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.
Time frame: 2 hours after returning to the ward on the day of surgery
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.
Time frame: 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
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.
The number of vomiting after surgery
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.
The use of remedial drugs after surgery
Drug used for anti-emetic or anti-dizziness after surgery.
Time frame: From the day of surgery to 72 hours 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.
Time frame: In PACU after extubation, and 2 hours, 6 hours, 24 hours, 48 hours, 72 hours after returning to the ward.
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.
Time frame: Before anesthesia induction, and before leaving PACU on the day of surgery.
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.
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.
Postoperative complications monitoring
The Clavien-Dindo grading system will be used.
Time frame: From the day of surgery to the day of discharge.
Postoperative duration of stay in hospital
The duration when patients stay in hospital after surgery.
Time frame: From the day of surgery to the day of discharge.
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.
Time frame: 4 weeks after discharge.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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