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

NCT01609517 | Completed

• 1 other identifier: 2012-04-089-001
• Study Type: observational
• Target: 209
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Anesthesia; Success or Failure of Spinal Anesthesia

Keywords

Spinal anesthesia; determinant; duration

Outcome Measures

Primary Outcomes (1)

• spinal anesthetic success/ failure

  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.

  at 2 hour after the anesthetic induction

Secondary Outcomes (4)

• Peak level of sensory block at anesthesia induction

  during 20 min after anesthetic 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

• Incidence of hypotension, bradycardia

  during 2 hours after anesthesia induction

Study Arms (2)

Obese group

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

Drug: Spinal anesthesia (heavy bupivacaine)

Non-obese group

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

Drug: Spinal anesthesia (heavy bupivacaine)

Interventions

Spinal anesthesia (heavy bupivacaine) DRUG

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

Also known as: Spinal anesthesia, heavy bupivacaine

Non-obese group; Obese group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are undergoing spinal anesthesia in Samsung Medical Center during study period

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Sangmin M. Lee, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

• Ji Sun Hahm, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 29, 2012
• First Posted: June 1, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 30, 2014

Record last verified: 2014-10

Locations

KR (1)