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Effect of Age on the Median Effective Dose(ED50) for Motor Block With Intrathecal Ropivacaine

Effect of Age on the Median Effective Dose(ED50) for Motor Block With Intrathecal Ropivacaine

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02102607
Acronym
Spinal
Enrollment
120
Registered
2014-04-03
Start date
2014-01-31
Completion date
2015-06-30
Last updated
2015-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

intrathecal; ropivacaine; motor blockade; local anesthetics

Brief 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.

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.

Interventions

OTHERage

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).

Sponsors

China Three Gorges University, Yichang, China
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Adult patients who were undergoing transurethral, urological or lower limb surgery, primarily under the spinal anesthesia

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

Design outcomes

Primary

MeasureTime frame
the dose of intrathecal ropivacaineat 5-min after administered ropivacaine

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026