- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04780139
Ultrasonographic Evaluation of Internal Jugular Vein Cross Sectional Area for Prediction of Post Spinal Hypotension
Ultrasonographic Evaluation of Internal Jugular Vein Cross Sectional Area for Prediction of Post Spinal Hypotension in Patients Undergoing Orthopedic Surgeries
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is to evaluate the efficacy of internal jugular cross sectional area for predicting the occurrence of PSAH. Spinal anaesthesia is frequently used in daily clinical practice. Postspinal anaesthesia hypotension (PSAH) is a common side effect with an incidence of 15.3 to 33% that may result in organ hypoperfusion and ischaemic events. Patients' susceptibility to intraoperative hypotension can be influenced by the sensory block level, age, preoperative volume status , physical status, pre-operative medications and fasting.
PSAH due to spinal blockade is principally a consequence of diminished systemic vascular resistance after blockade of preganglionic sympathetic fibres. Many attempts have been tried to prevent PSAH, such as intravenous volume preload or prophylactic vasopressors. However, fluid infusion has been proved to lower the incidence of PSAH and significantly decrease vasopressor requirements. At the same time, empirical volume loading carries the potential of volume overload, particularly in patients with cardiac disease. Consequently, the search for predictors of PSAH is becoming mandatory to avoid blind volume loading and reserve it only for patients who are expected to develop PSAH. .
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Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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القاهرة
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Cairo, القاهرة, Egypt
- Ain Shams University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients more than 40 years of age.
- American Society of Anesthesiologists' (ASA) physical status 1 or 2.
- scheduled for elective surgery under spinal anaesthesia in the supine position.
Exclusion Criteria:
- BMI more than 35 kg m2.
- taking angiotensin converting enzyme inhibitors.
- pregnant women.
- emergency cases.
- absolute or relative contraindications to spinal anaesthesia.
- Also, patients with a baseline arterial systolic blood pressure less than 90 mmHg or mean arterial blood pressure (MBP) less than 70 mmHg will be excluded.
Study Plan
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Predictive value of internal jugular vein (IJV) cross sectional area.
Time Frame: 30 minutes
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The primary outcome is to evaluate the predictive value of internal jugular diameter cross sectional area for detecting PSAH
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30 minutes
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sanaa Farag Mahmoud, MD, Anesthesiology department, Faculty of Medicine, Ain Shams University
- Principal Investigator: Eman Sabek, MD, Radiology department, National Centre of Radiation Research and Technology, Atomic Energy Authority
- Principal Investigator: WALID Nofal, MD, Anesthesiology department, Faculty of Medicine, Ain Shams Unive
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMASU R 25/2020/2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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