- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02141841
Effect of Age on the Median Effective Concentration(EC50) for Motor Block With Spinal Plain Bupivacaine
October 23, 2015 updated by: Mingquan Chen, China Three Gorges University, Yichang, China
This study was performed in 131 adult patients undergoing transurethral, urological or lower limb surgery under combined spinal and epidural anesthesia.
Patients were stratified according to age: 20-30, 31-40, 41-50, 51-60, 61-70, and 71-80 years.
The spinal component of the anesthetic was established by bolus administration of up-and-down doses of 0.75% plain bupivacaine, determined by Dixon's method.
The degree of motor block after intrathecal administration of each concentration was evaluated by the modified Bromage and Hip motor function score.
The EC50 were estimated from the up-and-down sequences using the method of Dixon and Massey and logistic regression.
Other endpoints were included on the basis of sensory block level, duration of motor blockade, hypotension, and vasopressor requirements.
Study Overview
Status
Withdrawn
Conditions
Study Type
Observational
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
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Hubei
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Yichang, Hubei, China, 443000
- China Three Gorges University
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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
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
This study was performed in 131 adult patients undergoing transurethral, urological or lower limb surgery under combined spinal and epidural anesthesia.
Description
Inclusion Criteria:
- ASA physical status I-II adult patients who were undergoing transurethral, urological or lower limb surgery, primarily under the spinal component of established combined epidural-spinal anesthesia, with the epidural component to be used if there was a need for intra-operative analgesic supplementation or for postoperative analgesia.
Exclusion Criteria:
- Patients with diabetes, obesity, neuromuscular diseases, bleeding diathesis, hypersensitivity to amide local anesthetics, lumbar vertebrae abnormality, chronic back pain, or who were pregnant were excluded from this study
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the median effect concentration of bupivacaine
Time Frame: The endpoint was determined according to the degree of motor power in any lower limb (according to the modified Bromage scale and the Hip motor function scale) within 5 minutes after intrathecal administration of the tested bupivacaine concentration
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The endpoint was determined according to the degree of motor power in any lower limb (according to the modified Bromage scale and the Hip motor function scale) within 5 minutes after intrathecal administration of the tested bupivacaine concentration
|
The endpoint was determined according to the degree of motor power in any lower limb (according to the modified Bromage scale and the Hip motor function scale) within 5 minutes after intrathecal administration of the tested bupivacaine concentration
|
sensory block level
Time Frame: 20 minutes
|
the sensory level was assessed by the pinprick or ice at interval 5 minutes and 2 0minutes after injection of spinal bupivacaine.
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20 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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
January 1, 2013
Primary Completion (Anticipated)
January 1, 2015
Study Completion (Anticipated)
January 1, 2015
Study Registration Dates
First Submitted
May 13, 2014
First Submitted That Met QC Criteria
May 19, 2014
First Posted (Estimate)
May 20, 2014
Study Record Updates
Last Update Posted (Estimate)
October 27, 2015
Last Update Submitted That Met QC Criteria
October 23, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- China Three Gorges University (China Three Gorges University)
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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