NCT01291186

Effect of Body-mass Index (BMI) on Median Effective Dose of Intrathecal Hyperbaric Bupivacaine

The Effect of BMI on Median Effective Dose (ED50) of Intrathecal Hyperbaric Bupivacaine for Total Knee Replacement Arthroplasty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Seoul Medical Center · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The effect of Body-mass index (BMI) on requirements of local anesthetics used in spinal anesthesia has not been well established. The investigators tried to quantify the effect of BMI on spinal anesthesia by comparing the median effective dose of intrathecal bupivacaine between two different BMI groups.

Detailed description

The effect of BMI on requirements of local anesthetics used in spinal anesthesia has not been well established. The investigators tried to quantify the effect of BMI on spinal anesthesia by comparing the median effective dose (ED50)of intrathecal bupivacaine between two different BMI groups. The investigators determined the ED50 and ED 95 of intrathecal hyperbaric bupivacaine of subjects with BMI below 27.5 kg/m2, and subjects with BMI over 27.5 kg/m2, respectively. By comparing the difference of ED50 and ED95 between the groups, the investigators tried to quantify the effect of BMI on the bupivacaine dose requirement.

Conditions

• Arthroplasty, Knee

Interventions

Type	Name	Description
DRUG	BPV6NO	intrathecal bupivacaine 6 mg for BMI less than 27.5 kg/m2
DRUG	BPV7NO	intrathecal bupivacaine 7 mg for BMI less than 27.5 kg/m2
DRUG	BPV8NO	intrathecal bupivacaine 8 mg for BMI less than 27.5 kg/m2
DRUG	BPV9NO	intrathecal bupivacaine 9 mg for BMI less than 27.5 kg/m2
DRUG	BPV10NO	intrathecal bupivacaine 10 mg for BMI less than 27.5 kg/m2
DRUG	BPV11NO	intrathecal bupivacaine 11 mg for BMI less than 27.5 kg/m2
DRUG	BPV6O	intrathecal bupivacaine 6 mg for BMI over 27.5 kg/m2
DRUG	BPV7O	intrathecal bupivacaine 7 mg for BMI over 27.5 kg/m2
DRUG	BPV8O	intrathecal bupivacaine 8 mg for BMI over 27.5 kg/m2
DRUG	BPV9O	intrathecal bupivacaine 9 mg for BMI over 27.5 kg/m2
DRUG	BPV10O	intrathecal bupivacaine 10 mg for BMI over 27.5 kg/m2
DRUG	BPV11O	intrathecal bupivacaine 11 mg for BMI over 27.5 kg/m2

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2011-02-08
• Last updated: 2011-08-03

Locations

1 site across 1 country: South Korea