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
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
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
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
