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Clinical Trials/NCT01609517
NCT01609517
Completed
Not Applicable

The Influence of Body-mass Index on the Outcome of Spinal Anesthesia for Total Knee Replacement Arthroplasty

Samsung Medical Center1 site in 1 country209 target enrollmentMay 2012

Overview

Phase
Not Applicable
Intervention
Spinal anesthesia (heavy bupivacaine)
Conditions
Spinal Anesthesia
Sponsor
Samsung Medical Center
Enrollment
209
Locations
1
Primary Endpoint
spinal anesthetic success/ failure
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

In these prospective observational study, the investigators are trying to evaluate (1) the influence of body-mass index on spinal anesthetic outcome and (2) the determinants on spinal anesthetic outcome by logistic regression analysis.

Detailed Description

Although the spread of spinal anesthetic drug is unpredictable, patients factors (age, gender, height,weight, body-mass index), spinal anatomy, anesthetic drug dose, and lumbosacral cerebrospinal fluid volume are known to be the determinants of sensory block level. Among these determinants, the influence of body-mass index (BMI) on spinal anesthesia is controversial, and there is no specific guideline showing the relative priority of these determinants. Therefore, in these prospective observational study, the investigators are trying to evaluate (1) the influence of body-mass index on spinal anesthetic outcome and (2) the relative influence of these determinants on spinal anesthetic outcome by logistic regression analysis.

Registry
clinicaltrials.gov
Start Date
May 2012
End Date
December 2012
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sangmin M. Lee

Professor

Samsung Medical Center

Eligibility Criteria

Inclusion Criteria

  • Patients who are undergoing spinal anesthesia in Samsung Medical Center during study period
  • American Society of Anesthesiologist Physical Status classification I \~ III

Exclusion Criteria

  • Bupivacaine allergy
  • medical history of spinal surgery
  • Diabetic neuropathy
  • active infection at the lumbosacral area
  • other contraindication of spinal anesthesia

Arms & Interventions

Obese group

patients with BMI \>= 30.0 kg/m2 who received spinal anesthesia with heavy marcaine

Intervention: Spinal anesthesia (heavy bupivacaine)

Non-obese group

patients with BMI \< 30.0 kg/m2 who received spinal anesthesia with heavy marcaine

Intervention: Spinal anesthesia (heavy bupivacaine)

Outcomes

Primary Outcomes

spinal anesthetic success/ failure

Time Frame: at 2 hour after the anesthetic induction

when (1) a bilateral T12 sensory block to pinprick within 15 minutes of intrathecal drug administration with sensory/motor block scale ≥ 2 and (2) the level of sensory block at the end of surgery was higher than or equal to T12 with sensory/motor block scale ≥ 2.

Secondary Outcomes

  • Incidence of hypotension, bradycardia(during 2 hours after anesthesia induction)
  • Spinal anesthesia sensory/motor block level at the end of surgery(2 hours after induction (at the end of surgery))
  • the incidence of tourniquet pain(at 90 min afer anesthetic induction)
  • Peak level of sensory block at anesthesia induction(during 20 min after anesthetic induction)

Study Sites (1)

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