Dysphagia Clinical Trial
— SGBOfficial title:
A Random Controlled Study to Explore the Effect of Stellate Ganglion Block on Post-Stroke Pharyngeal Dysphagia
Verified date | March 2024 |
Source | People's Hospital of Zhengzhou University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group (n=33) or the control group (n=33). Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment, Kubota water swallowing test, video fluoroscopic swallowing study (VFSS), and Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function.
Status | Terminated |
Enrollment | 65 |
Est. completion date | May 17, 2023 |
Est. primary completion date | May 2, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 80 Years |
Eligibility | Inclusion Criteria: - Age between 30 and 80 years; - New-onset stroke, confirmed by head CT or MRI; - The course of disease between 1 to 6 months; - With pharyngeal dysphagia shown by VFSS; - Stable vital signs; - Voluntary participation in the study. Exclusion Criteria: - Allergy to Lidocaine injection or vitamin B12 injection; - Severe cognitive impairment; - Coagulation disorders; - Severe dysfunction of organs including heart, lungs, kidney, liver, etc.; - Complicated with other neurological diseases; - With severe oral dysphagia (results of the VFSS oral phase as 2 or 3 points); - Dysphagia caused by other diseases or reasons. |
Country | Name | City | State |
---|---|---|---|
China | Zheng da yi fu yuan hospital | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Zeng Changhao |
China,
Bejot Y, Bailly H, Graber M, Garnier L, Laville A, Dubourget L, Mielle N, Chevalier C, Durier J, Giroud M. Impact of the Ageing Population on the Burden of Stroke: The Dijon Stroke Registry. Neuroepidemiology. 2019;52(1-2):78-85. doi: 10.1159/000492820. Epub 2019 Jan 2. — View Citation
Doi S, Cho N, Obara T. Stellate ganglion block increases blood flow in the anastomotic artery after superficial temporal artery-middle cerebral artery bypass. Br J Anaesth. 2016 Sep;117(3):395-6. doi: 10.1093/bja/aew230. No abstract available. — View Citation
GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3. — View Citation
Gilman RH, Marquis GS, Miranda E, Vestegui M, Martinez H. Rapid reinfection by Giardia lamblia after treatment in a hyperendemic Third World community. Lancet. 1988 Feb 13;1(8581):343-5. doi: 10.1016/s0140-6736(88)91131-2. — View Citation
Jones CA, Colletti CM, Ding MC. Post-stroke Dysphagia: Recent Insights and Unanswered Questions. Curr Neurol Neurosci Rep. 2020 Nov 2;20(12):61. doi: 10.1007/s11910-020-01081-z. — View Citation
Li TT, Wan Q, Zhang X, Xiao Y, Sun LY, Zhang YR, Liu XN, Yang WC. Stellate ganglion block reduces inflammation and improves neurological function in diabetic rats during ischemic stroke. Neural Regen Res. 2022 Sep;17(9):1991-1997. doi: 10.4103/1673-5374.3 — View Citation
ter Laan M, van Dijk JM, Elting JW, Staal MJ, Absalom AR. Sympathetic regulation of cerebral blood flow in humans: a review. Br J Anaesth. 2013 Sep;111(3):361-7. doi: 10.1093/bja/aet122. Epub 2013 Apr 24. — View Citation
Zhang G, Li Z, Gu H, Zhang R, Meng X, Li H, Wang Y, Zhao X, Wang Y, Liu G; Chinese Stroke Center Alliance investigators. Dysphagia Management and Outcomes in Elderly Stroke Patients with Malnutrition Risk: Results from Chinese Stroke Center Alliance. Clin Interv Aging. 2022 Mar 17;17:295-308. doi: 10.2147/CIA.S346824. eCollection 2022. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Video fluoroscopic swallowing study | The patient was required to take a sitting position with the head naturally upright. Under the guidance of the examiner, the patient first swallowed 5ml of iohexol solution (50ml:17.5g in iodine terms). If the patient exhibited aspiration, the test would stop. If not, the patient was instructed to swallow 10ml of iohexol solution mixed with breadcrumbs, and the patient's swallowing condition was observed with immediate measures ready to take for safety. Specially, the esophageal phase was not included in the study, because it was commonly regarded as an independent phase. The swallowing were divided into 3 phases in this assessment: Oral phase, Pharyngeal phase, and Aspiration, with maximum 3,3,4 points were given to each phase. The total score was calculated as the final result. The final score was positively correlated with the swallowing function. | day 1 and day 20 | |
Secondary | Kubota water swallowing test | During the test, patients were required to drink 30 ml of warm water. According to the situation, the swallowing function was rated from Level 1 (excellent) to Level 5 (poor). Specifically, Grade 1: The patient drank all the water at once without choking; Grade II: The patient drank all the water in two or more times without choking; Grade III: The patient drank all the water at once with choking; Grade IV: The patient drank all the water in two or more times with choking; Grade V: The patient exhibited difficulty drinking with frequent choking. Besides, we evaluated the efficacy as: 1) Recovery: The patient's symptoms of dysphagia disappear with grade 1 in the test. 2) Improvement: The patient shows improvement in dysphagia with the water the grade of the test improved. 3) Invalid: The patient's dysphagia deteriorates or did not improve, with the grade of the test not improved. (Overall effective rate = Recovery rate + Improvement rate). | day 1 and day 20 | |
Secondary | Rosenbek penetration-aspiration scale | Based on VFSS, this assessment evaluated the patient's swallowing of contrast medium and whether there was retention, penetration, and aspiration. It included multiple items, each with the corresponding criteria, Specifically, whether the swallowed material entered the airway, passed through or contacted the vocal cords, and whether the patient exhibited the corresponding ability to clear. There were 8 levels in the results, with higher levels indicating more severe aspiration. | day 1 and day 20 |
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