Elderly PatientsNCT04065763
Correlation of the Dural Sac Dimension With the Spread of Spinal Anesthesia
An observational study of Elderly Patients, run by SMG-SNU Boramae Medical Center at 1 site in South Korea.
Trial summary
Cerebrospinal fluid volume is an important factor that influences peak block height and regression of sensory and motor blockade. The aim of this study is to evaluate the effect of dural sac dimension on the spread of spinal anesthesia in elderly patient using ultrasound. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Elderly Patients
- What is being tested?
- Ultrasound assessment of dural sac dimension
- How many people
- 41 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Oct 2019to 14 Feb 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 65 years and older
- Women only
- Older adult
Study population: Female patients older than 65 years of age who are undergoing elective surgery under spinal anesthesia
Who may be able to join
- Patients who are scheduled for elective surgery under spinal anesthesia
Who cannot join
- Known anatomical abnormality or pathology in the spine
- History of lumbar spinal surgery or compression fracture
- Height less than 150 cm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation of the Dural Sac Dimension With the Spread of Spinal Anesthesia in Elderly Patients
Cerebrospinal fluid volume is an important factor that influences peak block height and regression of sensory and motor blockade. The aim of this study is to evaluate the effect of dural sac dimension on the spread of spinal anesthesia in elderly patient using ultrasound.
- Conditions
- Elderly Patients
- Being tested
- Ultrasound assessment of dural sac dimension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound assessment of dural sac dimensionOther
Dural sac dimension is assessed using ultrasonography in the lateral decubitus position for spinal anesthesia.
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the dural sac dimension and spinal anesthesia spread (peak sensory block)
The dural sac dimension is assessed before spinal anesthesia. After spinal anesthesia, the sensory and motor level are evaluated. Then, the correlation between the dural sac dimension and spinal anesthesia blockade is assessed.
Measured: At 30 minutes after the induction of spinal anesthesia
Secondary outcomes (4)
Correlation between the dural sac dimension and duration of spinal anesthesia
The sensory and motor regression are assessed. Then, the correlation between the dural sac dimension and the duration of spinal blockade is assessed.
Measured: At 30 minutes after the end of surgery
Correlation between the dural sac dimension and body mass index
Correlation between the dural sac dimension and body mass index is assessed.
Measured: 5 minutes before spinal anesthesia
Correlation between the dural sac dimension and waist circumference
Correlation between the dural sac dimension and waist circumference is assessed.
Measured: 5 minutes before spinal anesthesia
Correlation between the dural sac dimension and age
Correlation between the dural sac dimension and age is assessed.
Measured: 5 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 posted22 Aug 2019
- Study start10 Oct 2019
- Primary completion14 Feb 2020
- Study completion14 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly PatientsStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- SMG-SNU Boramae Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Young Hwang, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065763
- Sponsor's protocol ID
- 2019-02
- Status last verified
- Mar 2020
- First submitted
- 12 Aug 2019
- Last updated
- 11 Mar 2020
- 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 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of the Dural Sac Dimension With the Spread of Spinal Anesthesia in Elderly Patients
- ClinicalTrials.gov ID
- NCT04065763
- Acronym / sponsor ID
- 2019-02
- Conditions
- Elderly Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- SMG-SNU Boramae Medical CenterUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 14 Feb 2020 (actual)
- Study completion
- 14 Feb 2020 (actual)
- First posted
- 22 Aug 2019 (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.
Cerebrospinal fluid volume is an important factor that influences peak block height and regression of sensory and motor blockade. The aim of this study is to evaluate the effect of dural sac dimension on the spread of spinal anesthesia in elderly patient using ultrasound.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Age groups
- Older adult
- Study population
- Female patients older than 65 years of age who are undergoing elective surgery under spinal anesthesia
Key inclusion criteria (1 listed)
- Patients who are scheduled for elective surgery under spinal anesthesia
Key exclusion criteria (3 listed)
- Known anatomical abnormality or pathology in the spine
- History of lumbar spinal surgery or compression fracture
- Height less than 150 cm
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 |
|---|---|---|
| Ultrasound assessment of dural sac dimensionDural sac dimension is assessed using ultrasonography in the lateral decubitus position for spinal anesthesia. | Other | – |
Primary outcome
Correlation between the dural sac dimension and spinal anesthesia spread (peak sensory block)
Time frame: At 30 minutes after the induction of spinal anesthesia
The dural sac dimension is assessed before spinal anesthesia. After spinal anesthesia, the sensory and motor level are evaluated. Then, the correlation between the dural sac dimension and spinal anesthesia blockade is assessed.
4 secondary outcomes
Correlation between the dural sac dimension and duration of spinal anesthesia
Time frame: At 30 minutes after the end of surgery
Correlation between the dural sac dimension and body mass index
Time frame: 5 minutes before spinal anesthesia
Correlation between the dural sac dimension and waist circumference
Time frame: 5 minutes before spinal anesthesia
Correlation between the dural sac dimension and age
Time frame: 5 minutes before spinal anesthesia
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 11 Mar 2020.
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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.
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 Elderly Patients, run by SMG-SNU Boramae Medical Center at 1 site in South Korea.
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 3 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 11 Mar 2020. 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 South Korea. 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?
Correlation between the dural sac dimension and spinal anesthesia spread (peak sensory block) (time frame: At 30 minutes after the induction of 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 11 Mar 2020.