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

Seoul Medical Center

Status: Completed

Conditions: Arthroplasty, Knee

Treatments: Drug: BPV6NO; Drug: BPV11NO; Drug: BPV10NO; Drug: BPV11O; Drug: BPV7O; Drug: BPV8O; Drug: BPV8NO; Drug: BPV9O; Drug: BPV10O; Drug: BPV6O; Drug: BPV9NO; Drug: BPV7NO

Study type: Interventional

Funder types: Other

Identifiers

NCT01291186

SMC-2010-1-14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing elective total knee replacement arthroplasty

Exclusion criteria

• Patients with previous spine surgery, diabetic and other neuropathy, skin infection at the site of injection, allergy to bupivacaine and other common contraindications for spinal anesthesia were excluded from this study.
• The patients with height less than 140 cm or more than 160 cm, body-mass index (BMI) less than 20 or greater than 35 were also excluded.

Trial design

108 participants in 12 patient groups

BPV6NO

Experimental group

Treatment:

Drug: BPV6NO

BPV7NO

Experimental group

Treatment:

Drug: BPV7NO

BPV8NO

Experimental group

Treatment:

Drug: BPV8NO

BPV9NO

Experimental group

Treatment:

Drug: BPV9NO

BPV10NO

Experimental group

Treatment:

Drug: BPV10NO

BPV11NO

Experimental group

Treatment:

Drug: BPV11NO

BPV6O

Active Comparator group

Treatment:

Drug: BPV6O

BPV7O

Active Comparator group

Treatment:

Drug: BPV7O

BPV8O

Active Comparator group

Treatment:

Drug: BPV8O

BPV9O

Active Comparator group

Treatment:

Drug: BPV9O

BPV10O

Active Comparator group

Treatment:

Drug: BPV10O

BPV11O

Active Comparator group

Treatment:

Drug: BPV11O