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

This study has been completed.
Sponsor:
Information provided by:
Seoul Medical Center
ClinicalTrials.gov Identifier:
NCT01291186
First received: February 7, 2011
Last updated: August 2, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition Intervention
Arthroplasty, Knee
 Drug: BPV6NO
Drug: BPV7NO
Drug: BPV8NO
Drug: BPV9NO
Drug: BPV10NO
Drug: BPV11NO
Drug: BPV6O
Drug: BPV7O
Drug: BPV8O
Drug: BPV9O
Drug: BPV10O
Drug: BPV11O

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: The Effect of BMI on Median Effective Dose (ED50) of Intrathecal Hyperbaric Bupivacaine for Total Knee Replacement Arthroplasty

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul Medical Center:

Primary Outcome Measures:
  • success of spinal anesthesia [ Time Frame: every ten minutes during the surgery ] [ Designated as safety issue: No ]
    a bilateral T12 sensory level to pinprick within 10 min of the intrathecal drug administration with no additional epidural anesthetics required during the surgery


Secondary Outcome Measures:
  • time to first request for supplemental analgesia [ Time Frame: every ten minutes during and after surgery ] [ Designated as safety issue: No ]
    for failure cases: it is the time of failure for success cases : it is the time of first postoperative pain


Enrollment: 108
Study Start Date: January 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BPV6NO Drug: BPV6NO
intrathecal bupivacaine 6 mg for BMI less than 27.5 kg/m2
Other Names:
  • bupivacaine
  • epinephrine
Experimental: BPV7NO Drug: BPV7NO
intrathecal bupivacaine 7 mg for BMI less than 27.5 kg/m2
Other Names:
  • bupivacaine
  • epinephrine
Experimental: BPV8NO Drug: BPV8NO
intrathecal bupivacaine 8 mg for BMI less than 27.5 kg/m2
Other Names:
  • bupivacaine
  • epinephrine
Experimental: BPV9NO Drug: BPV9NO
intrathecal bupivacaine 9 mg for BMI less than 27.5 kg/m2
Other Names:
  • bupivacaine
  • epinephrine
Experimental: BPV10NO Drug: BPV10NO
intrathecal bupivacaine 10 mg for BMI less than 27.5 kg/m2
Other Names:
  • bupivacaine
  • epinephrine
Experimental: BPV11NO Drug: BPV11NO
intrathecal bupivacaine 11 mg for BMI less than 27.5 kg/m2
Other Names:
  • bupivacaine
  • epinephrine
Active Comparator: BPV6O Drug: BPV6O
intrathecal bupivacaine 6 mg for BMI over 27.5 kg/m2
Other Names:
  • bupivacaine
  • epinephrine
Active Comparator: BPV7O Drug: BPV7O
intrathecal bupivacaine 7 mg for BMI over 27.5 kg/m2
Other Names:
  • bupivacaine
  • epinephrine
Active Comparator: BPV8O Drug: BPV8O
intrathecal bupivacaine 8 mg for BMI over 27.5 kg/m2
Other Names:
  • bupivacaine
  • epinephrine
Active Comparator: BPV9O Drug: BPV9O
intrathecal bupivacaine 9 mg for BMI over 27.5 kg/m2
Other Names:
  • bupivacaine
  • epinephrine
Active Comparator: BPV10O Drug: BPV10O
intrathecal bupivacaine 10 mg for BMI over 27.5 kg/m2
Other Names:
  • bupivacaine
  • epinephrine
Active Comparator: BPV11O Drug: BPV11O
intrathecal bupivacaine 11 mg for BMI over 27.5 kg/m2
Other Names:
  • bupivacaine
  • epinephrine

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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01291186

Locations
Korea, Republic of
Seoul Medical Center
Seoul, Korea, Republic of, 135-740
Sponsors and Collaborators
Seoul Medical Center
Investigators
Principal Investigator: Won Ho Kim, M.D. Seoul Medical Center
  More Information

No publications provided

Responsible Party: Won Ho Kim M.D., Seoul Medical Center
ClinicalTrials.gov Identifier: NCT01291186     History of Changes
Other Study ID Numbers: SMC-2010-1-14
Study First Received: February 7, 2011
Last Updated: August 2, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul Medical Center:
spinal anesthesia
intrathecal bupivacaine
median effective dose
height

Additional relevant MeSH terms:
Epinephrine
Epinephryl borate
Bupivacaine
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
 Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013