The Influence of Body-mass Index on the Outcome of Spinal Anesthesia for Total Knee Replacement Arthroplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Samsung Medical Center
- Enrollment
- 209
- Locations
- 1
- Primary Endpoint
- spinal anesthetic success/ failure
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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) (Drug)
Non-obese group
patients with BMI < 30.0 kg/m2 who received spinal anesthesia with heavy marcaine
Intervention: Spinal anesthesia (heavy bupivacaine) (Drug)
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)
Investigators
Sangmin M. Lee
Professor
Samsung Medical Center