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

Post-spinal Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05078606
• Other study ID #: MD-152-2020
• Status: Completed
• Start date: October 7, 2021
• Est. completion date: January 21, 2022

Study information

• Verified date: February 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: January 21, 2022
• Est. primary completion date: November 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypotension
• Post-spinal Hypotension

Intervention

Device:
• IJV Ultrasonography
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
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.

Procedure:
• Spinal anesthesia
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.

Locations

Country	Name	City	State
Egypt	Kasr Alainy hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

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