Spinal Anesthetics Causing Adverse Effects in Therapeutic UseNCT05991063
The Ability Of Inferior Vena Caval Distensibility Index With Passive Leg Raising Test To Predict Spinal Anesthesia-induced Hypotension In Elderly Patients Undergoing Infra-umbilical Surgeries. A Prospective Observational Study.
An observational study of Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, run by Cairo University.
Trial summary
Many previous studies have investigated the ability of various methods such as passive leg raising test , and inferior vena cava collapsibility index in predicting post-spinal hypotension, but none of them have succeeded in obtaining a good predictive value. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Feb 2024
- 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 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: A total of 68 consecutive elderly patients, aged >65 years scheduled for elective infra-umbilical surgical operations under spinal anesthesia will be included in the study.
Who may be able to join
- 1. 65 years of age or more. 2. ASA score I \& II. 3. Patients are scheduled for infra umbilical surgeries under spinal anesthesia.
Who cannot join
- Negative consent. Pre-existing hypertension Diabetes mellitus or autonomic neuropathy (patients diagnosed with autonomic neuropathy or having suggestive symptoms such as orthostatic hypotension, syncopal attacks, decreased sweating, and urinary incontinence) Emergency operations Absolute contraindications or failure to perform spinal anesthesia If PLR maneuver is contraindicated (intracranial hypertension) or possibly unreliable ( venous compression stocking, intraabdominal hypertension) Difficulties in IVC visualization due to increased subcutaneous fat tissue or gastric gas interferin
About this study
Many previous studies have investigated the ability of various methods such as passive leg raising test , and inferior vena cava collapsibility index in predicting post-spinal hypotension, but none of them have succeeded in obtaining a good predictive value.
Our study aims to combine the passive leg raising test with the inferior vena cava distensibility index to aid in predicting post-spinal hypotension in elderly undergoing infra-umbilical surgeries.
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity of Δmax.IVCd in predicting post-spinal anesthesia hypotension in elderly patients.
The incremental changes of measured maximum inferior vena caval diameter after passive leg raising
Measured: 15 minutes before spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study startSep 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Anesthetics Causing Adverse Effects in Therapeutic UseStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed abdelghany ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991063
- Sponsor's protocol ID
- Ms2022
- Status last verified
- Aug 2023
- First submitted
- 6 Aug 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ability Of Inferior Vena Caval Distensibility Index With Passive Leg Raising Test To Predict Spinal Anesthesia-induced Hypotension In Elderly Patients Undergoing Infra-umbilical Surgeries. A Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT05991063
- Acronym / sponsor ID
- Ms2022
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 14 Aug 2023 (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.
Many previous studies have investigated the ability of various methods such as passive leg raising test , and inferior vena cava collapsibility index in predicting post-spinal hypotension, but none of them have succeeded in obtaining a good predictive value.
Our study aims to combine the passive leg raising test with the inferior vena cava distensibility index to aid in predicting post-spinal hypotension in elderly undergoing infra-umbilical surgeries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- A total of 68 consecutive elderly patients, aged >65 years scheduled for elective infra-umbilical surgical operations under spinal anesthesia will be included in the study.
Key inclusion criteria (1 listed)
- 1. 65 years of age or more. 2. ASA score I \& II. 3. Patients are scheduled for infra umbilical surgeries under spinal anesthesia.
Key exclusion criteria (1 listed)
- Negative consent. Pre-existing hypertension Diabetes mellitus or autonomic neuropathy (patients diagnosed with autonomic neuropathy or having suggestive symptoms such as orthostatic hypotension, syncopal attacks, decreased sweating, and urinary incontinence) Emergency operations Absolute contraindications or failure to perform spinal anesthesia If PLR maneuver is contraindicated (intracranial hypertension) or possibly unreliable ( venous compression stocking, intraabdominal hypertension) Difficulties in IVC visualization due to increased subcutaneous fat tissue or gastric gas interferin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The sensitivity of Δmax.IVCd in predicting post-spinal anesthesia hypotension in elderly patients.
Time frame: 15 minutes before spinal anesthesia
The incremental changes of measured maximum inferior vena caval diameter after passive leg raising
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, run by Cairo University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
The sensitivity of Δmax.IVCd in predicting post-spinal anesthesia hypotension in elderly patients. (time frame: 15 minutes before spinal anesthesia). 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 14 Aug 2023.