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

NCT ID: NCT01609517

Last Updated: 2014-10-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 209 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2012-12-31

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.

Conditions

Spinal Anesthesia; Success or Failure of Spinal Anesthesia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Obese group

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

Spinal anesthesia (heavy bupivacaine)

Intervention Type: DRUG

Spinal anesthesia with heavy bupivacaine of 6, 7, 8, 9, 10, 11 mg

Non-obese group

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

Spinal anesthesia (heavy bupivacaine)

Intervention Type: DRUG

Spinal anesthesia with heavy bupivacaine of 6, 7, 8, 9, 10, 11 mg

Interventions

Spinal anesthesia (heavy bupivacaine)

Spinal anesthesia with heavy bupivacaine of 6, 7, 8, 9, 10, 11 mg

Intervention Type: DRUG

Other Intervention Names

Spinal anesthesia; heavy bupivacaine

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sangmin M. Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sangmin M. Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Ji Sun Hahm, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2012-04-089-001

Identifier Type: -

Identifier Source: org_study_id