- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04065763
Correlation of the Dural Sac Dimension With the Spread of Spinal Anesthesia
March 9, 2020 updated by: Jin-Young Hwang, SMG-SNU Boramae Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
41
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
-
-
-
Seoul, Korea, Republic of
- SMG-SNU Boramae Medical Center
-
-
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
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Female patients older than 65 years of age who are undergoing elective surgery under spinal anesthesia
Description
Inclusion Criteria:
- Patients who are scheduled for elective surgery under spinal anesthesia
Exclusion Criteria:
- Known anatomical abnormality or pathology in the spine
- History of lumbar spinal surgery or compression fracture
- Height less than 150 cm
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
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At 30 minutes after the induction of spinal anesthesia
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between the dural sac dimension and duration of spinal anesthesia
Time Frame: At 30 minutes after the end of surgery
|
The sensory and motor regression are assessed.
Then, the correlation between the dural sac dimension and the duration of spinal blockade is assessed.
|
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 body mass index is assessed.
|
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 waist circumference is assessed.
|
5 minutes before spinal anesthesia
|
Correlation between the dural sac dimension and age
Time Frame: 5 minutes before spinal anesthesia
|
Correlation between the dural sac dimension and age is assessed.
|
5 minutes before 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)
October 10, 2019
Primary Completion (Actual)
February 14, 2020
Study Completion (Actual)
February 14, 2020
Study Registration Dates
First Submitted
August 12, 2019
First Submitted That Met QC Criteria
August 21, 2019
First Posted (Actual)
August 22, 2019
Study Record Updates
Last Update Posted (Actual)
March 11, 2020
Last Update Submitted That Met QC Criteria
March 9, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 2019-02
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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