Skip to main content
OpenTrials
Completed

NCT Number: NCT02102607

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

China Three Gorges University

Yichang, Hubei, 443003, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

age

Other

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).

Primary outcomes

  1. the dose of intrathecal ropivacaine

    Time frame: at 5-min after administered ropivacaine

Sponsors and collaborators

Lead sponsor

China Three Gorges University, Yichang, China

Other

Registry information

Acronym: Spinal

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 3, 2014
Registry last updated
Oct 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.