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

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

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.

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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