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

NCT02141841 | Withdrawn DMC

• 1 other identifier: China Three Gorges University
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Mononeuropathy of the Median Nerve, Mild

Keywords

intrathecal;; bupivacaine;; concentration;

Outcome Measures

Primary Outcomes (2)

• the median effect concentration of bupivacaine

  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

  the sensory level was assessed by the pinprick or ice at interval 5 minutes and 2 0minutes after injection of spinal bupivacaine.

  20 minutes

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• China Three Gorges University, Yichang, China: lead

Study Sites (1)

China Three Gorges University

Yichang, Hubei, 443000, China

Location

Related Links

• Related Info

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: China Three Gorges University, Yichang, China

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 20, 2014
• Study Start: January 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: October 27, 2015

Record last verified: 2015-10

Locations

CN (1)