AnesthesiaSpinalNCT02102607
Effect of Age on the Median Effective Dose(ED50) for Motor Block With Intrathecal Ropivacaine
An observational study of Anesthesia, run by China Three Gorges University, Yichang, China at 1 site in China.
Trial summary
The primary aim of this study was to determine the median effective dose (ED50) for motor block of intrathecally-administered ropivacaine in adults (20-80 years), and to assess the effect of age on ED50 required for motor block. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- age
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who were undergoing transurethral, urological or lower limb surgery, primarily under the spinal anesthesia
Who may be able to join
- Adult patients who were undergoing transurethral, urological or lower limb surgery, primarily under the spinal anesthesia
Who cannot join
- Patients with diabetes, obesity, neuromuscular diseases, bleeding diathesis, hypersensitivity to amide local anesthetics, lumbar vertebrae abnormality, chronic back pain, or who were pregnant
Trial locations and contacts
1 site in 1 country.
About this study
The primary aim of this study was to determine the median effective dose (ED50) for motor block of intrathecally-administered ropivacaine in adults (20-80 years), and to assess the effect of age on ED50 required for motor block.
Read the detailed description
This study was performed in 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 various up-and-down doses of 0.75% ropivacaine, determined by Dixon's method, with the first patient receiving 15 mg, and with testing intervals of 1.5 mg according to failure or success of the preceding patient's motor block. The degree of motor block after intrathecal administration of each dose was evaluated by the modified Bromage and Hip motor function score. The primary outcome was obtained by administration of the mean dosage that was determined from the midpoints of all independent pairs of patients involving a crossover from failure to success during 5 minutes after the spinal injection. The ED50 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.
- Conditions
- Anesthesia
- Being tested
- age
- Keywords
- intrathecal; ropivacaine; motor blockade; local anesthetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ageOther
subjects stratified according to age: 20-30 years (Group 1), 31-40 years (Group 2), 41-50 years (Group 3), 51-60 years (Group 4), 61-70 years (Group 5), and 71-80 years (Group 6).
| Study group | Role | What they receive |
|---|---|---|
| age | subjects stratified according to age: 20-30 years (Group 1), 31-40 years (Group 2), 41-50 years (Group 3), 51-60 years (Group 4), 61-70 years (Group 5), and 71-80 years (Group 6). Receives: Other: age |
What is being measured
The primary outcome is the main question the study is designed to answer.
the dose of intrathecal ropivacaine
Measured: at 5-min after administered ropivacaine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Three Gorges University, Yichang, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingquan Chen, China Three Gorges University, Yichang, China
- Investigators
- jun yang, PhD, Study director, China Three Gorges University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102607
- Sponsor's protocol ID
- intrathecal ropivacaine
- Other IDs
- China Three Gorges University
- Acronym
- Spinal
- Status last verified
- Oct 2015
- First submitted
- 24 Mar 2014
- Last updated
- 27 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee YY, Ngan Kee WD, Fong SY, Liu JT, Gin T. The median effective dose of bupivacaine, levobupivacaine, and ropivacaine after intrathecal injection in lower limb surgery. Anesth Analg. 2009 Oct;109(4):1331-4. doi: 10.1213/ane.0b013e3181b1912b.
PubMed 19762766Gupta R, Bogra J, Singh PK, Saxena S, Chandra G, Kushwaha JK. Comparative study of intrathecal hyperbaric versus isobaric ropivacaine: A randomized control trial. Saudi J Anaesth. 2013 Jul;7(3):249-53. doi: 10.4103/1658-354X.115326.
PubMed 24015125
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Age on the Median Effective Dose(ED50) for Motor Block With Intrathecal Ropivacaine
- ClinicalTrials.gov ID
- NCT02102607
- Acronym / sponsor ID
- Spinal / intrathecal ropivacaine
- Conditions
- Anesthesia
- Keywords
- intrathecal; ropivacaine; motor blockade; local anesthetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- China Three Gorges University, Yichang, ChinaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 3 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study was to determine the median effective dose (ED50) for motor block of intrathecally-administered ropivacaine in adults (20-80 years), and to assess the effect of age on ED50 required for motor block.
Detailed description
This study was performed in 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 various up-and-down doses of 0.75% ropivacaine, determined by Dixon's method, with the first patient receiving 15 mg, and with testing intervals of 1.5 mg according to failure or success of the preceding patient's motor block. The degree of motor block after intrathecal administration of each dose was evaluated by the modified Bromage and Hip motor function score. The primary outcome was obtained by administration of the mean dosage that was determined from the midpoints of all independent pairs of patients involving a crossover from failure to success during 5 minutes after the spinal injection. The ED50 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 design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| age | – | Other: agesubjects stratified according to age: 20-30 years (Group 1), 31-40 years (Group 2), 41-50 years (Group 3), 51-60 years (Group 4), 61-70 years (Group 5), and 71-80 years (Group 6). |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who were undergoing transurethral, urological or lower limb surgery, primarily under the spinal anesthesia
Key inclusion criteria (1 listed)
- Adult patients who were undergoing transurethral, urological or lower limb surgery, primarily under the spinal anesthesia
Key exclusion criteria (1 listed)
- Patients with diabetes, obesity, neuromuscular diseases, bleeding diathesis, hypersensitivity to amide local anesthetics, lumbar vertebrae abnormality, chronic back pain, or who were pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| agesubjects stratified according to age: 20-30 years (Group 1), 31-40 years (Group 2), 41-50 years (Group 3), 51-60 years (Group 4), 61-70 years (Group 5), and 71-80 years (Group 6). | Other | age |
Primary outcome
the dose of intrathecal ropivacaine
Time frame: at 5-min after administered ropivacaine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2015.
- Background: PubMed 19762766Lee YY, Ngan Kee WD, Fong SY, Liu JT, Gin T. The median effective dose of bupivacaine, levobupivacaine, and ropivacaine after intrathecal injection in lower limb surgery. Anesth Analg. 2009 Oct;109(4):1331-4. doi: 10.1213/ane.0b013e3181b1912b.
- Background: PubMed 24015125Gupta R, Bogra J, Singh PK, Saxena S, Chandra G, Kushwaha JK. Comparative study of intrathecal hyperbaric versus isobaric ropivacaine: A randomized control trial. Saudi J Anaesth. 2013 Jul;7(3):249-53. doi: 10.4103/1658-354X.115326.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jun yang, PhD study director
China Three Gorges University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by China Three Gorges University, Yichang, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the dose of intrathecal ropivacaine (time frame: at 5-min after administered ropivacaine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02102607, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2015.