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NCT Number: NCT05078606

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

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.

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Key information

Conditions

Post-spinal Hypotension

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kasr Alainy hospital

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IJV Ultrasonography

Device

Patient will be in supine position, The linear probe with frequency of 7- 12 M hz; depth of 3 cm. maximum IJV diameter (IJV-D) and area (IJV-A) will be recorded. M-mode will be used to obtain the distance between the 2 walls of the vein during inspiration and expiration.

Then, the patient will be positioned 10° Trendelenburg and similar ultrasonographic measurements will be again performed

Carotid Intima Media Thickness

Device

US Probe is slided superiorly (toward the head) or inferiorly (toward the feet) until the bifurcation of the common carotid artery (CCA) appears on the left side of the screen. This is the ideal location for imaging and CIMT measurements.

IMT is assessed in longitudinal view from the arterial far wall, along a 10mm length. CIMT will appear as two parallel lines (leading edges of two anatomical boundaries) from it: lumen- intima and media- adventitia interfaces perpendicular to ultrasound beams.

Spinal anesthesia

Procedure

Spinal anesthesia will be performed in the sitting position at level of L3-4 or L4- 5 interspaces with a 25-gauge spinal needle. Local infiltration of skin and subcutaneous tissue with 2% lignocaine will be applied. After confirming cerebrospinal fluid flow, 10 mg of 0.5% hyperbaric bupivacaine plus 25 mcg fentanyl will be injected. The degree of sensory block (cold test by alcohol gauze) will be assessed in the study with a goal of T8 dermatomal level block.

Primary outcomes

  1. Accuracy of IJV collapsibility index as predictor of Spinal anesthesia induced hypotension.

    Time frame: 10 minutes

    (Area under receiver operating characteristic curves)

Secondary outcomes

  1. Accuracy of rate of change in IJV area with change in posture as a predictor of Spinal anesthesia induced hypotension.

    Time frame: 10 minutes

    (Area under receiver operating characteristic curves)

  2. Incidence of Spinal anesthesia induced hypotension

    Time frame: 20 minutes

    Change in mean arterial blood pressure 25% less than the preoperative baseline level.

  3. Carotid intima media thickness.

    Time frame: 10 minutes

    IMT is measured as the distance between lumen-intima and media-adventitia interfaces

  4. Norepinephrine consumption

    Time frame: 20 minutes

    the total dose of norepiniphrine and number of boluses

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Pre-anesthetic Ultrasonographic Assessment of Neck Vessels as Predictors of Spinal Anesthesia Induced Hypotension in Elderly: a Prospective Observational Study.

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Oct 14, 2021
Registry last updated
Feb 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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