Effect of Body-mass Index (BMI) on Median Effective Dose of Intrathecal Hyperbaric Bupivacaine
Information source: Seoul Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Arthroplasty, Knee
Intervention: BPV6NO (Drug); BPV7NO (Drug); BPV8NO (Drug); BPV9NO (Drug); BPV10NO (Drug); BPV11NO (Drug); BPV6O (Drug); BPV7O (Drug); BPV8O (Drug); BPV9O (Drug); BPV10O (Drug); BPV11O (Drug)
Phase: N/A
Status: Completed
Sponsored by: Seoul Medical Center Official(s) and/or principal investigator(s): Won Ho Kim, M.D., Principal Investigator, Affiliation: Seoul Medical Center
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.
Clinical Details
Official title: The Effect of BMI on Median Effective Dose (ED50) of Intrathecal Hyperbaric Bupivacaine for Total Knee Replacement Arthroplasty
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
Primary outcome: success of spinal anesthesia
Secondary outcome: time to first request for supplemental analgesia
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.
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Seoul Medical Center, Seoul 135-740, Korea, Republic of
Additional Information
Starting date: January 2010
Last updated: August 2, 2011
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