Post-spinal Anesthesia HypotensionNCT04780139
Ultrasonographic Evaluation of Internal Jugular Vein Cross Sectional Area for Prediction of Post Spinal Hypotension
An observational study of Post-spinal Anesthesia Hypotension, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the efficacy of internal jugular cross sectional area for predicting the occurrence of PSAH. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-spinal Anesthesia Hypotension
- What is being tested?
- Ultrasonographic Evaluation of Internal Jugular Vein Cross Sectional Area
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 21 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients more than 40 years of age with American Society of Anesthesiologists' (ASA) physical status 1 or 2 who will be scheduled for elective orthopedic surgery under spinal anaesthesia in the supine position
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasonographic Evaluation of Internal Jugular Vein Cross Sectional Area for Prediction of Post Spinal Hypotension in Patients Undergoing Orthopedic Surgeries
The aim of this study is to evaluate the efficacy of internal jugular cross sectional area for predicting the occurrence of PSAH.
Read the 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. .
.
- Conditions
- Post-spinal Anesthesia Hypotension
- Being tested
- Ultrasonographic Evaluation of Internal Jugular Vein Cross Sectional Area
- Keywords
- internal jugular vein, ultrasound, spinal anesthesia, Hypotension
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographic Evaluation of Internal Jugular Vein Cross Sectional AreaDiagnostic test
Measuring the internal jugular vein cross section area and relate this to the incidence of hypotension after spinal anesthesia.
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of internal jugular vein (IJV) cross sectional area.
The primary outcome is to evaluate the predictive value of internal jugular diameter cross sectional area for detecting PSAH
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start1 Mar 2021
- Primary completion21 Jul 2021
- Study completion21 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-spinal Anesthesia HypotensionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid Nofal, Ain Shams University
- Investigators
- Sanaa Farag Mahmoud, MD, Principal investigator, Anesthesiology Department, Faculty of Medicine, Ain Shams UniversityEman Sabek, MD, Principal investigator, Radiology department, National Centre of Radiation Research and Technology, Atomic Energy AuthorityWALID Nofal, MD, Principal investigator, Anesthesiology department, Faculty of Medicine, Ain Shams Unive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780139
- Sponsor's protocol ID
- FMASU R 25/2020/2021
- Status last verified
- Jul 2021
- First submitted
- 28 Feb 2021
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Evaluation of Internal Jugular Vein Cross Sectional Area for Prediction of Post Spinal Hypotension in Patients Undergoing Orthopedic Surgeries
- ClinicalTrials.gov ID
- NCT04780139
- Acronym / sponsor ID
- FMASU R 25/2020/2021
- Conditions
- Post-spinal Anesthesia Hypotension
- Keywords
- internal jugular vein, ultrasound, spinal anesthesia, Hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 21 Jul 2021 (actual)
- Study completion
- 21 Jul 2021 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the efficacy of internal jugular cross sectional area for predicting the occurrence of PSAH.
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. .
.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients more than 40 years of age with American Society of Anesthesiologists' (ASA) physical status 1 or 2 who will be scheduled for elective orthopedic surgery under spinal anaesthesia in the supine position
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- BMI more than 35 kg m2.
- taking angiotensin converting enzyme inhibitors.
- pregnant women.
- emergency cases.
- absolute or relative contraindications to spinal anaesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonographic Evaluation of Internal Jugular Vein Cross Sectional AreaMeasuring the internal jugular vein cross section area and relate this to the incidence of hypotension after spinal anesthesia. | Diagnostic test | – |
Primary outcome
Predictive value of internal jugular vein (IJV) cross sectional area.
Time frame: 30 minutes
The primary outcome is to evaluate the predictive value of internal jugular diameter cross sectional area for detecting PSAH
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Individual participant dataSharing planned: No
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Comparison of Prophylactic Continuous Infusion of Norepinephrine, Ephedrine, and Their Combination for Prevention of Hypotension During Spinal Anaesthesia for Caesarean Delivery
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Norepinephrine With Ephedrine Versus Norepinephrine Alone During Spinal Anesthesia for Cesarean Delivery
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Pupillary Light Reflex to Predict Post-Spinal Hypotension in Elective Cesarean Delivery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanaa Farag Mahmoud, MD principal investigator
Anesthesiology Department, Faculty of Medicine, Ain Shams University
Eman Sabek, MD principal investigator
Radiology department, National Centre of Radiation Research and Technology, Atomic Energy Authority
WALID Nofal, MD principal investigator
Anesthesiology department, Faculty of Medicine, Ain Shams Unive
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-spinal Anesthesia Hypotension, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive value of internal jugular vein (IJV) cross sectional area. (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.