Ultrasonographic Assessment of Neck Vessels as Predictors of Spinal Anesthesia Induced Hypotension in Elderly

Completed

• Conditions: Post-spinal Hypotension

• Registration Number: NCT05078606
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2021-10-04
• Study First Submitted QC: 2021-10-04
• Study Start: 2021-10-07
• Study First Posted: 2021-10-14
• Primary Completion: 2021-11-10
• Study Completion: 2022-01-21
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-03
• Last Update Posted: 2022-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of IJV collapsibility index as predictor of Spinal anesthesia induced hypotension.	10 minutes	(Area under receiver operating characteristic curves)

Secondary Outcome Measures

Name	Time	Method
Accuracy of rate of change in IJV area with change in posture as a predictor of Spinal anesthesia induced hypotension.	10 minutes	(Area under receiver operating characteristic curves)
Carotid intima media thickness.	10 minutes	IMT is measured as the distance between lumen-intima and media-adventitia interfaces
Norepinephrine consumption	20 minutes	the total dose of norepiniphrine and number of boluses
Incidence of Spinal anesthesia induced hypotension	20 minutes	Change in mean arterial blood pressure 25% less than the preoperative baseline level.

Trial Locations

Locations (1)

Kasr Alainy hospital; 🇪🇬 Cairo, Egypt