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
Verified date | May 2022 |
Source | Peking University People's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Peking University People's Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University People's Hospital |
China,
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
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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