- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05078606
Ultrasonographic Assessment of Neck Vessels as Predictors of Spinal Anesthesia Induced Hypotension in Elderly
Pre-anesthetic Ultrasonographic Assessment of Neck Vessels as Predictors of Spinal Anesthesia Induced Hypotension in Elderly: a Prospective Observational Study.
Spinal anesthesia induces sympathetic blockade and venodilation, thus reducing venous return and the cardiac output. Therefore, assessment of intravascular volume deficit before anesthesia might predict a critical decrease in blood pressure after anesthesia.
Recently, ultrasonographic evaluation of the internal jugular vein (IJV) has been used to reflect intravascular volume status and fluid and as a predictor of hypotension after induction of general anesthesia.
Carotid intima-media thickness (CIMT) has been used to predict atherosclerosis-related events, such as stroke, myocardial infarction, peripheral artery disease, and hypotension after induction of anesthesia with a cut-off value of 0.65 mm of CIMT as a threshold level.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study aims to evaluate the ability of preoperative Ultrasonographic assessment of the internal jugular vein (IJV) and Carotid intima-media thickness (CIMT) to predict spinal anesthesia induced hypotension (SAIH).
Participants will be elderly patients (above 60 years), ASA I-II-III, scheduled for elective surgeries under spinal anesthesia.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Cairo, Egypten
- Kasr Alainy hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Adult patients (>60 years)
- ASA I-II-III
- Patients scheduled for elective surgeries under spinal anesthesia.
Exclusion Criteria:
- Operations which will last for less than 15 minutes.
- Deep vein thrombosis in the upper extremities.
- History of radiotherapy or neck surgery.
- Previous sonographic data show tricuspid or mitral regurgitation or a very distended right atrium and ventricle.
- Patients with history of valvular or carotid artery surgery, arrhythmia, heart failure.
- Being unable to lie in a supine position for the necessary measurements.
- Technical limitations to imaging of the IJV and carotid artery.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Accuracy of IJV collapsibility index as predictor of Spinal anesthesia induced hypotension.
Tidsramme: 10 minutes
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(Area under receiver operating characteristic curves)
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10 minutes
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Accuracy of rate of change in IJV area with change in posture as a predictor of Spinal anesthesia induced hypotension.
Tidsramme: 10 minutes
|
(Area under receiver operating characteristic curves)
|
10 minutes
|
Incidence of Spinal anesthesia induced hypotension
Tidsramme: 20 minutes
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Change in mean arterial blood pressure 25% less than the preoperative baseline level.
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20 minutes
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Carotid intima media thickness.
Tidsramme: 10 minutes
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IMT is measured as the distance between lumen-intima and media-adventitia interfaces
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10 minutes
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Norepinephrine consumption
Tidsramme: 20 minutes
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the total dose of norepiniphrine and number of boluses
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20 minutes
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Bassant abdelhamid, Cairo University
Publikationer og nyttige links
Generelle publikationer
- Singh Y, Anand RK, Gupta S, Chowdhury SR, Maitra S, Baidya DK, Singh AK. Role of IVC collapsibility index to predict post spinal hypotension in pregnant women undergoing caesarean section. An observational trial. Saudi J Anaesth. 2019 Oct-Dec;13(4):312-317. doi: 10.4103/sja.SJA_27_19.
- Pre-operative ultrasonographic evaluation of inferior vena cava collapsibility index and caval aorta index as new predictors for hypotension after induction of spinal anaesthesia: A prospective observational study: erratum. Eur J Anaesthesiol. 2019 Nov;36(11):888. doi: 10.1097/EJA.0000000000001094. No abstract available.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MD-152-2020
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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