Clinical trial NCT05078606: Ultrasonographic Assessment of Neck Vessels as Predictors of Spinal Anesthesia Induced Hypotension in Elderly
Official title: Pre-anesthetic Ultrasonographic Assessment of Neck Vessels as Predictors of Spinal Anesthesia Induced Hypotension in Elderly: a Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-spinal Hypotension
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 71
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be elderly patients (above 60 years), ASA I-II-III, scheduled for elective surgeries under spinal anesthesia.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy of IJV collapsibility index as predictor of Spinal anesthesia induced hypotension.
timeFrame: 10 minutes
Secondary outcomes:
measure: Accuracy of rate of change in IJV area with change in posture as a predictor of Spinal anesthesia induced hypotension.
timeFrame: 10 minutes
measure: Incidence of Spinal anesthesia induced hypotension
timeFrame: 20 minutes
measure: Carotid intima media thickness.
timeFrame: 10 minutes
measure: Norepinephrine consumption
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy hospital
Study officials:
affiliation: Cairo University
name: Bassant abdelhamid
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.