- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07652749
Stellate Ganglion Block and Prognosis of Neurological Function After Subarachnoid Hemorrhage
Effect of Stellate Ganglion Block on the Prognosis of Neurological Function After Subarachnoid Hemorrhage
The incidence of cerebral vasospasm after aneurysm subarachnoid hemorrhage (aSAH) is as high as 70%; cerebral vasospasm(CVS) is closely related to delayed cerebral ischemia (DCI), which is one of the important reasons for poor outcomes in patients with aSAH.
In recent years, it has been reported that stellate ganglion block(SGB) can effectively alleviate cerebral vasospasm(CVS), reduce cerebral blood flow velocity and increase cerebral perfusion in patients with aneurysm subarachnoid hemorrhage(aSAH)。However, whether the alleviation of CVS after SGB is beneficial to the long-term neurological prognosis has not been confirmed Therefore, a prospective randomized controlled study is needed to further explore the role of SGB block in improving the outcomes of patients with aSAH.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Ruquan Han, M.D., Ph.D
- Telefonnummer: 8610-59976660
- E-post: ruquan.han@gmail.com
Studiesteder
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100070
- Beijing Tiantan Hospital, Capital Medical University
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Ta kontakt med:
- Ruquan Han, M.D., Ph.D
- Telefonnummer: 8610-59976660
- E-post: ruquan.han@gmail.com
-
Hovedetterforsker:
- Ruquan Han, M.D., Ph.D
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Age range: 18-65 years old;
- Within 72 hours after onset of aSAH,and planning surgical treatment(aneurysm embolizing or clipping);
- Preoperative Hunt-Hess grade 2-3
- Sign informed consent.
Exclusion Criteria:
- ASA > grade IV;
- Patients with posterior circulation aneurysm;
- Patients with severe systemic hemorrhagic diseases;
- Patients with trauma and local infection in the nerve block area;
- Local anatomic structure changes (neck structure changes caused by radiotherapy, chemotherapy and surgery);
- Allergy to known local anesthetics;
- Pregnant and lactating women.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Intervention group
In addition to routine anesthesia management and surgical operations, an ultrasound-guided stellate ganglion block was performed once prior to the initiation of surgery, and then receive standard care after operation.
Related statistical indicators were collected prospectively.
|
Prior to the initiation of surgery, a single ultrasound-guided stellate ganglion block was performed on the ipsilateral side of the lesion.The dose and concentration of local anesthesia: 0.5% ropivacaine 5-10ml.
Criteria for successful block: the patient developed Horner's syndrome, characterized by miosis, ptosis, eyeball caved in, nasal congestion, conjunctival congestion, reddish face and no sweat on the face
Andre navn:
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Ingen inngripen: Blank control group
In this study, a blank control was used.
Routine anesthesia management and surgical operation were used without any special interventions, and then receive standard care after operation.
Only relevant statistical indicators were collected prospectively.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The modified Rankin Scale (mRS) scores at 90 days
Tidsramme: 90 days postoperatively
|
The modified Rankin Scale (mRS) is used to evaluate the primary outcome.
The scale of mRS is 0 to 6.
The best neurological outcome is the mRS with 0, indicating no any symptom left.
mRS of 6 is the worst, indicating death.
mRS will be evaluated by outcomes assessor who is blinded to the grouping.
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90 days postoperatively
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The incidence of delayed cerebral ischemia (DCI) during hospitalization
Tidsramme: At discharge, an average of 2 weeks
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At discharge, an average of 2 weeks
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All cause mortality during 90 days after onset
Tidsramme: 90 days postoperatively
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90 days postoperatively
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Length of stay in the intensive care unit and hosipital
Tidsramme: At discharge, an average of two weeks
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At discharge, an average of two weeks
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Adverse events during hospitalization
Tidsramme: At discharge, an average of 2 weeks
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Myocardial infarction, cardiac arrest, pulmonary embolism, infection, SGB related complications, etc
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At discharge, an average of 2 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Ruquan Han, M.D., Ph.D, Beijing Tiantan Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Z191100006619069
Legemiddel- og utstyrsinformasjon, studiedokumenter
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