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

NCT ID: NCT05078606

Last Updated: 2022-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-07

Study Completion Date

2022-01-21

Brief Summary

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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

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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.

Conditions

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Post-spinal Hypotension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Bassant M. Abdelhamid

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bassant abdelhamid

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Kasr Alainy hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 31572075 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31580292 (View on PubMed)

Other Identifiers

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MD-152-2020

Identifier Type: -

Identifier Source: org_study_id

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