NCT04065763

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 22, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 10, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2020

Completed
Last Updated

March 11, 2020

Status Verified

March 1, 2020

Enrollment Period

4 months

First QC Date

August 12, 2019

Last Update Submit

March 9, 2020

Conditions

Elderly Patients

Outcome Measures

Primary Outcomes (1)

  • 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.

    At 30 minutes after the induction of spinal anesthesia

Secondary Outcomes (4)

  • Correlation between the dural sac dimension and duration of spinal anesthesia

    At 30 minutes after the end of surgery

  • Correlation between the dural sac dimension and body mass index

    5 minutes before spinal anesthesia

  • Correlation between the dural sac dimension and waist circumference

    5 minutes before spinal anesthesia

  • Correlation between the dural sac dimension and age

    5 minutes before spinal anesthesia

Interventions

Ultrasound assessment of dural sac dimensionOTHER

Dural sac dimension is assessed using ultrasonography in the lateral decubitus position for spinal anesthesia.

Eligibility Criteria

Age65 Years+
Sexfemale
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female patients older than 65 years of age who are undergoing elective surgery under spinal anesthesia

You may qualify if:

  • Patients who are scheduled for elective surgery under spinal anesthesia

You may not qualify if:

  • Known anatomical abnormality or pathology in the spine
  • History of lumbar spinal surgery or compression fracture
  • Height less than 150 cm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SMG-SNU Boramae Medical Center

Seoul, South Korea

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 12, 2019

First Posted

August 22, 2019

Study Start

October 10, 2019

Primary Completion

February 14, 2020

Study Completion

February 14, 2020

Last Updated

March 11, 2020

Record last verified: 2020-03

Locations

KR(1)