UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009850
Receipt number R000011476
Scientific Title The effect of lithotomy position on peripheral vascular resistance after spinal anesthesia
Date of disclosure of the study information 2013/01/24
Last modified on 2013/01/23 18:51:01

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Basic information

Public title

The effect of lithotomy position on peripheral vascular resistance after spinal anesthesia

Acronym

The effect of lithotomy position on peripheral vascular resistance after spinal anesthesia

Scientific Title

The effect of lithotomy position on peripheral vascular resistance after spinal anesthesia

Scientific Title:Acronym

The effect of lithotomy position on peripheral vascular resistance after spinal anesthesia

Region

Japan


Condition

Condition

ASA physical status 1 or 2 ,undergoing surgery with spinal anesthesia

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The perfusion index (PI)is the ratio of the pulsatile blood flow to the nonpulsatile blood flow and static blood in peripheral tissue.this is likely to useful for measuring change in peripheral vascular resistance in real time.It has been reported that the blood flow increases in the lower extremity and decreases in the upper extremity during spinal anesthesia.We hypothesize that PI in upper extremity in lithotomy position induces a smaller decrease compare with that in supine position.We evaluated the influence of position on PI changes in upper extremity and hemodynamics during spinal anesthesia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Blood pressure, heart rate and PI were recorded for 20min. Anesthetic level was checked by cold thermal hypesthesia using ice.

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

ASA physical status1or2,undergoing surgery with spinal anesthesia

Key exclusion criteria

More than ASA phisical status 3, arteriosclerosis obliterans or cesarean section

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tanabe Kumiko

Organization

Gifu University Hospital

Division name

Department of Anesthesiology&Pain Medicine

Zip code


Address

1-1 Yanagido Gifu-city

TEL

058-230-6404

Email



Public contact

Name of contact person

1st name
Middle name
Last name Kato Mayumi

Organization

Gifu University Hospital

Division name

Department of Anesthesiology&Pain Medicine

Zip code


Address

1-1 Yanagido Gifu-city

TEL

058-230-6404

Homepage URL


Email



Sponsor or person

Institute

Gifu University Hospital
Department of Anesthesiology&Pain Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

岐阜大学医学部付属病院(岐阜県)


Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 24 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2010 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 10 Month 14 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

ASA physical status 1 or 2 were enrolled in the present study. Pulse oximetry with tissue PI monitor was used. The probes were placed on the left finger and toe, and then spinal anesthesia was performed at the left lateral position. After intrathecal administration of 10-13mg of hyperbaric bupivacine, the patients were returned to the supine position. L-group patients were placed in the lithotomy position soon after the injection of local anesthetics. S-group patients were maintained in the supine position. Blood pressure, heart rate and PI were recorded for 20min. Anesthetic level was checked by cold thermal hypesthesia using ice. Ephedrine 5mg was administrated intravenously against hypotension more than 20% from baseline.


Management information

Registered date

2013 Year 01 Month 23 Day

Last modified on

2013 Year 01 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011476


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name