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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

Page last updated: August 23, 2015

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