Spinal Anesthetics Causing Adverse Effects in Therapeutic UseIJVNCT04486612
Ultrasonographic Measurement of Internal Jugular Vein as a Predictor of Hypotension Following Spinal Anesthesia
An observational study of Spinal Anesthetics Causing Adverse Effects in Therapeutic Use and Hypotension Postprocedural, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
Hypotension after spinal anesthesia is associated with significant perioperative morbidity and mortality, especially in hypovolemic patients. Ultrasonographic measurement of internal jugular vein (IJV) has been recently shown as effective in predicting the intravascular volume status. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, Hypotension Postprocedural
- What is being tested?
- spinal anesthesia
- How many people
- 47 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 24 Sep 2020
- 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 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Patients between the ages of 18-65
Who may be able to join
- Patients between the ages of 18-65 Patients who read and accept the consent form of the study Patients undergoing elective surgery under spinal anesthesia
Who cannot join
- under 18 years old, ASA scores 3-4, presence of any significant hepatic, renal, cardiavasculary, or respiratory disease, having left ventricular ejection fraction less than 40%, and allergy to study medications.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskişehir Osmangazi Univercity
Eskişehir, 26040
About this study
Official title: Department of Anesthesiology and Reanimation, Faculty of Medicine, Osmangazi University, Eskişehir, Turkey
Hypotension after spinal anesthesia is associated with significant perioperative morbidity and mortality, especially in hypovolemic patients. Ultrasonographic measurement of internal jugular vein (IJV) has been recently shown as effective in predicting the intravascular volume status. The aim was to investigate the reliability of preanesthetic ultrasound measurements of IJV in predicting hypotension after spinal anesthesia.
Read the detailed description
Hypotension after spinal anesthesia is associated with significant perioperative morbidity and mortality, especially in hypovolemic patients. Ultrasonographic measurement of internal jugular vein (IJV) has been recently shown as effective in predicting the intravascular volume status. The aim was to investigate the reliability of preanesthetic ultrasound measurements of IJV in predicting hypotension after spinal anesthesia.
- Being tested
- spinal anesthesia
- Keywords
- spinal anesthesia, internal jugular vein, hypotension, ultrasonography
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anesthesiaOther
prospective observational study
| Study group | Role | What they receive |
|---|---|---|
| hypotension | Not described Receives: Other: spinal anesthesia | |
| non-hypotension | Not described Receives: Other: spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The association between sonographic measurements and postspinal hypotension
The aim of the study is to evaluate the association between sonographic measurements and postinduction hypotension.
Measured: first 30 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start1 Jan 2020
- Primary completion24 Sep 2020
- Study completion24 Sep 2020
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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeliz KILIÇ, Eskisehir Osmangazi University
- Investigators
- yeliz kılıç, Ass. Prof, Principal investigator, Eskişehir Osmangazi Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486612
- Sponsor's protocol ID
- 10.12.19/43
- Acronym
- IJV
- Status last verified
- Feb 2021
- First submitted
- 22 Jul 2020
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Anesthesiology and Reanimation, Faculty of Medicine, Osmangazi University, Eskişehir, Turkey
- ClinicalTrials.gov ID
- NCT04486612
- Acronym / sponsor ID
- IJV / 10.12.19/43
- Keywords
- spinal anesthesia, internal jugular vein, hypotension, ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 24 Sep 2020 (actual)
- Study completion
- 24 Sep 2020 (actual)
- First posted
- 24 Jul 2020 (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.
Hypotension after spinal anesthesia is associated with significant perioperative morbidity and mortality, especially in hypovolemic patients. Ultrasonographic measurement of internal jugular vein (IJV) has been recently shown as effective in predicting the intravascular volume status. The aim was to investigate the reliability of preanesthetic ultrasound measurements of IJV in predicting hypotension after spinal anesthesia.
Detailed description
Hypotension after spinal anesthesia is associated with significant perioperative morbidity and mortality, especially in hypovolemic patients. Ultrasonographic measurement of internal jugular vein (IJV) has been recently shown as effective in predicting the intravascular volume status. The aim was to investigate the reliability of preanesthetic ultrasound measurements of IJV in predicting hypotension after spinal anesthesia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypotension | – | Other: spinal anesthesia |
| non-hypotension | – | Other: spinal anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients between the ages of 18-65
Key inclusion criteria (1 listed)
- Patients between the ages of 18-65 Patients who read and accept the consent form of the study Patients undergoing elective surgery under spinal anesthesia
Key exclusion criteria (1 listed)
- under 18 years old, ASA scores 3-4, presence of any significant hepatic, renal, cardiavasculary, or respiratory disease, having left ventricular ejection fraction less than 40%, and allergy to study medications.
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 |
|---|---|---|
| spinal anesthesiaprospective observational study | Other | hypotension, non-hypotension |
Primary outcome
The association between sonographic measurements and postspinal hypotension
Time frame: first 30 minute
The aim of the study is to evaluate the association between sonographic measurements and postinduction hypotension.
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 3 Feb 2021.
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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.
yeliz kılıç, Ass. Prof principal investigator
Eskişehir Osmangazi Univercity
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 Spinal Anesthetics Causing Adverse Effects in Therapeutic Use and Hypotension Postprocedural, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 3 Feb 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 Turkey (Türkiye). 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?
The association between sonographic measurements and postspinal hypotension (time frame: first 30 minute). 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 3 Feb 2021.