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

Anesthesia Clinical Trial

— Spinal  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02102607
• Other study ID #: intrathecal ropivacaine
• Secondary ID: China Three Gorg
• Status: Completed
• Phase: N/A
• First received: March 24, 2014
• Last updated: October 23, 2015
• Start date: January 2014
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: China Three Gorges University, Yichang, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Anesthesia

Intervention

Other:
• 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).

Locations

Country	Name	City	State
China	China Three Gorges University	Yichang	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
China Three Gorges University, Yichang, China

Country where clinical trial is conducted

China, 

References & Publications (2)

Gupta 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the dose of intrathecal ropivacaine		at 5-min after administered ropivacaine	Yes