- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05342311
Preoperative Ultrasonographic Evaluation of the Right Common Femoral Vein Diameter for Predicting Spinal Anesthesia-induced Hypotension in Elderly Patients
January 5, 2024 updated by: Amr Ahmed Mahmoud AbdelKader, Cairo University
Preoperative Ultrasonographic Evaluation of the Right Common Femoral Vein Diameter for Predicting Spinal Anesthesia-induced Hypotension in Elderly Patients. A Prospective Observational Study.
In this study we will determine the ability of preoperative ultrasonographic evaluation of the right common femoral vein diameter to predict spinal anesthesia-induced hypotension in elderly patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
68
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Giza
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Cairo, Giza, Egypt, 202
- Cairo University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
A total of 68 consecutive elderly patients, aged >65 years scheduled for elective surgical operations under spinal anesthesia will be included in the study.
Description
Inclusion Criteria:
- 65 years of age or more.
- ASA score I & II.
- Patients scheduled for surgeries under spinal anesthesia.
Exclusion Criteria:
- Negative consent.
- pre-existing hypertension
- Diabetes mellitus or autonomic neuropathy.
- Emergency operations.
- Absolute contraindications or failure to perform spinal anesthesia.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The sensitivity of the transverse diameter (mm) value of the right common femoral vein as measured by ultrasound before anesthesia to predict spinal aneshesia-induced hypotension in elderly patients.
Time Frame: 30 minutes after spinal anesthesia
|
30 minutes after spinal anesthesia
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of spinal anesthesia-induced hypotension in elderly
Time Frame: 30 minutes after spinal anesthesia
|
30 minutes after spinal anesthesia
|
|
The sensitivity of the peak velocity of blood flow (mm/s) in the right common femoral vein as measured by ultrasound before anesthesia to predict spinal anesthesia-induced hypotension in elderly patients
Time Frame: 30 minutes after spinal anesthesia
|
30 minutes after spinal anesthesia
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 3, 2022
Primary Completion (Actual)
January 5, 2024
Study Completion (Actual)
January 5, 2024
Study Registration Dates
First Submitted
April 16, 2022
First Submitted That Met QC Criteria
April 16, 2022
First Posted (Actual)
April 22, 2022
Study Record Updates
Last Update Posted (Estimated)
January 8, 2024
Last Update Submitted That Met QC Criteria
January 5, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MD-10-2022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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