Clinical Trial: Effect of Age on the Median Effective Concentration(EC50) for Motor Block With Spinal Plain Bupivacaine

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational [Patient Registry]

Official Title: Effect of Age on the Median Effective Concentration(EC50) for Motor Block With Spinal Plain Bupivacaine

Brief Summary: 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.

Detailed Summary:
Sponsor: China Three Gorges University, Yichang, China

Current Primary Outcome:

  • 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 ]
    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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: China Three Gorges University, Yichang, China

Dates:
Date Received: May 13, 2014
Date Started: January 2013
Date Completion: January 2015
Last Updated: October 23, 2015
Last Verified: October 2015