NCT01091779

Brief Summary

Changes of Upper and Lower Limb Blood Flow and Vascular Resistance in Hyperbaric Spinal Anesthesia for TURP Using Duplex Ultrasonography: Comparison of Normotensive and Hypertensive Patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2009

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2010

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

Enrollment Period

4 months

First QC Date

March 23, 2010

Last Update Submit

January 26, 2012

Conditions

Keywords

Male patients scheduled to have spinal anaesthesia for TURP

Outcome Measures

Primary Outcomes (1)

  • venous flow velocity, blood volume flow, resistance index, pulsatility index, diameter of popliteal vein

    10 minutes after spinal block

Study Arms (1)

Hypertensive and normotensive

Eligibility Criteria

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

Male patients scheduled elective transurethral surgery

You may qualify if:

  • males (\> 65 yr) were scheduled to have spinal anaesthesia for TURP

You may not qualify if:

  • patients with peripheral vascular disease
  • chronic venous insufficiency
  • prior deep vein thrombosis (DVT) defined by the presence of thrombosis on duplex or the presence of ultrasonographic signs indicating a previous DVT
  • body mass index \>35
  • prior lower limb surgery due to arterial or venous trauma
  • history of diabetes or autonomic deficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea

Location

Related Publications (1)

  • Kil HK, Suk EH, Lee MH, Bang EC, Hong JY. Venous flow dynamics during spinal block in normotensive and hypertensive elderly patients: a duplex ultrasonographic study. Acta Anaesthesiol Scand. 2012 Mar;56(3):376-81. doi: 10.1111/j.1399-6576.2011.02617.x. Epub 2012 Jan 19.

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2010

First Posted

March 24, 2010

Study Start

November 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

January 31, 2012

Record last verified: 2012-01

Locations