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

NCT05078606 | Completed DMC

• 1 other identifier: MD-152-2020
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-spinal Hypotension

Outcome Measures

Primary Outcomes (1)

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

  (Area under receiver operating characteristic curves)

  10 minutes

Secondary Outcomes (4)

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

  10 minutes

• Incidence of Spinal anesthesia induced hypotension

  20 minutes

• Carotid intima media thickness.

  10 minutes

• Norepinephrine consumption

  20 minutes

Interventions

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.

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult patients (\>60 years)
• ASA I-II-III
• Patients scheduled for elective surgeries under spinal anesthesia.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy hospital

Cairo, Egypt

Location

Related Publications (2)

• 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.

  PMID: 31572075 BACKGROUND

• 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.

  PMID: 31580292 BACKGROUND

MeSH Terms

Interventions

Carotid Intima-Media Thickness; Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Ultrasonography, Carotid Arteries; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Bassant abdelhamid

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 14, 2021
• Study Start: October 7, 2021
• Primary Completion: November 10, 2021
• Study Completion: January 21, 2022
• Last Updated: February 21, 2022

Record last verified: 2022-02

Locations

EG (1)