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
1 other identifier
interventional
108
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 7, 2011
CompletedFirst Posted
Study publicly available on registry
February 8, 2011
CompletedAugust 3, 2011
January 1, 2011
11 months
February 7, 2011
August 2, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
success of spinal anesthesia
a bilateral T12 sensory level to pinprick within 10 min of the intrathecal drug administration with no additional epidural anesthetics required during the surgery
every ten minutes during the surgery
Secondary Outcomes (1)
time to first request for supplemental analgesia
every ten minutes during and after surgery
Study Arms (12)
BPV6NO
EXPERIMENTALBPV7NO
EXPERIMENTALBPV8NO
EXPERIMENTALBPV9NO
EXPERIMENTALBPV10NO
EXPERIMENTALBPV11NO
EXPERIMENTALBPV6O
ACTIVE COMPARATORBPV7O
ACTIVE COMPARATORBPV8O
ACTIVE COMPARATORBPV9O
ACTIVE COMPARATORBPV10O
ACTIVE COMPARATORBPV11O
ACTIVE COMPARATORInterventions
intrathecal bupivacaine 6 mg for BMI less than 27.5 kg/m2
intrathecal bupivacaine 7 mg for BMI less than 27.5 kg/m2
intrathecal bupivacaine 8 mg for BMI less than 27.5 kg/m2
intrathecal bupivacaine 9 mg for BMI less than 27.5 kg/m2
intrathecal bupivacaine 10 mg for BMI less than 27.5 kg/m2
intrathecal bupivacaine 11 mg for BMI less than 27.5 kg/m2
intrathecal bupivacaine 6 mg for BMI over 27.5 kg/m2
intrathecal bupivacaine 7 mg for BMI over 27.5 kg/m2
intrathecal bupivacaine 8 mg for BMI over 27.5 kg/m2
intrathecal bupivacaine 9 mg for BMI over 27.5 kg/m2
intrathecal bupivacaine 10 mg for BMI over 27.5 kg/m2
intrathecal bupivacaine 11 mg for BMI over 27.5 kg/m2
Eligibility Criteria
You may qualify if:
- Patients undergoing elective total knee replacement arthroplasty
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul Medical Center
Seoul, 135-740, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Won Ho Kim, M.D.
Seoul Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 7, 2011
First Posted
February 8, 2011
Study Start
January 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
August 3, 2011
Record last verified: 2011-01