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Correlation of the Dural Sac Dimension With the Spread of Spinal Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04065763
Recruitment Status : Completed
First Posted : August 22, 2019
Last Update Posted : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
Jin-Young Hwang, SMG-SNU Boramae Medical Center

Brief 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.

Condition or disease Intervention/treatment
Elderly Patients Other: Ultrasound assessment of dural sac dimension

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Study Type : Observational
Actual Enrollment : 41 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Correlation of the Dural Sac Dimension With the Spread of Spinal Anesthesia in Elderly Patients
Actual Study Start Date : October 10, 2019
Actual Primary Completion Date : February 14, 2020
Actual Study Completion Date : February 14, 2020

Intervention Details:
  • Other: Ultrasound assessment of dural sac dimension
    Dural sac dimension is assessed using ultrasonography in the lateral decubitus position for spinal anesthesia.


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes 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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065763


Locations
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Korea, Republic of
SMG-SNU Boramae Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
SMG-SNU Boramae Medical Center
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Responsible Party: Jin-Young Hwang, Associate professor, SMG-SNU Boramae Medical Center
ClinicalTrials.gov Identifier: NCT04065763    
Other Study ID Numbers: 2019-02
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No